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WO2022036462A1 - Formes galéniques buccales comprenant des oligosaccharides - Google Patents

Formes galéniques buccales comprenant des oligosaccharides Download PDF

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Publication number
WO2022036462A1
WO2022036462A1 PCT/CA2021/051161 CA2021051161W WO2022036462A1 WO 2022036462 A1 WO2022036462 A1 WO 2022036462A1 CA 2021051161 W CA2021051161 W CA 2021051161W WO 2022036462 A1 WO2022036462 A1 WO 2022036462A1
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WO
WIPO (PCT)
Prior art keywords
oligosaccharides
dosage form
buccal dosage
lozenge
polymerization
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CA2021/051161
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English (en)
Inventor
Qingru ZHOU
Jeremie Adrien DOIRON
Jason Mathieu HARQUAIL
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Organigram Inc
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Organigram Inc
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Filing date
Publication date
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Publication of WO2022036462A1 publication Critical patent/WO2022036462A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733—Fructosans, e.g. inulin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/348—Cannabaceae
    • A61K36/3482—Cannabis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present application relates to buccal dosage of one or more cannabinoids, and/or a cannabinoid extract and one or more oligosaccharides such as fructo-oligosaccharide and optionally with one or more polysaccharides and/or glycerin and to methods of preparation thereof.
  • the present application also relates to buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer such glycerin. More particularly, the buccal dosage forms are hard molded lozenges, soft chew lozenges, and/or compressed tablets.
  • Buccal dosage forms such as hard molded lozenge, soft chew lozenges, and compressed tablets comprising one or more cannabinoid and/or cannabinoid extracts and one or more oligosaccharides such as fructo-oligosaccharide alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin have been prepared.
  • Buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer such glycerin have also been prepared. Accordingly, the present application includes a buccal dosage form comprising:
  • the present application also includes a buccal dosage wherein the buccal dosage form is a hard molded lozenge comprising:
  • the present application also includes a buccal dosage wherein the buccal dosage form is a hard molded lozenge comprising:
  • (d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying agents.
  • the present application also includes a buccal dosage wherein the buccal dosage form is a hard molded lozenge comprising:
  • flavourant optionally about 0.1% (w/w) to about 1% (w/w) of a flavourant.
  • the present application also includes a buccal dosage wherein the buccal dosage form is a hard molded lozenge comprising:
  • the present application also includes a hard molded lozenge comprising:
  • the present application also includes a hard molded lozenge comprising:
  • (d) optionally about 0.1 (w/w) to about 3% (w/w) of one or more emulsifying agents.
  • the present application also includes a buccal dosage form wherein the buccal dosage form is a soft chew lozenge, the soft chew lozenge comprising:
  • the present application includes a soft chew lozenge comprising:
  • the present application includes a soft chew lozenge comprising: (a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a cannabinoid extract;
  • the present application includes a soft chew lozenge comprising:
  • the present application also includes a buccal dosage form wherein the buccal dosage form is a compressed tablet lozenge, the compressed tablet lozenge comprising:
  • the present application includes a compressed tablet lozenge comprising:
  • the present application includes a compressed tablet lozenge comprising: (a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a cannabinoid extract;
  • oils and/or fats optionally 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats.
  • the present application includes a compressed tablet lozenge comprising:
  • the buccal dosage forms have been prepared without any added sugars, sweeteners, or sweetening agents.
  • the present application also includes a method of treating diseases, disorders or conditions that benefit from treatment from one or more cannabinoids and/or cannabinoid extract.
  • the present application also includes methods of preparing the buccal dosage forms of the application.
  • the buccal dosage forms of the present application optionally comprises, consists of, or consists essentially of the embodiments described herein.
  • Figure 1 is a picture showing an exemplary hard molded lozenge (top panel) and exemplary soft chew lozenge (bottom panel).
  • Figure 2 shows exemplary hard molded lozenges that have been portioned and sized using a drop roller machine.
  • A is a picture showing a slab of formed exemplary hard molded lozenges using a drop roller machine.
  • B is a picture showing individual exemplary hard molded lozenge produced using a drop roller machine after they have been cooled, separated and polished using a jewelry tumbler.
  • Figure 3 is a graph showing the change in appropriate drop roller manipulation temperature of exemplary hard molded FOS lozenge compositions with varying concentration of glycerin, various exemplary hard molded FOS:lnulin lozenge compositions and comparative traditional sugar candy compositions.
  • Figure 4 is a graph (expressed in log scale cP) showing glycerin’s ability to reduce the temperature dependant viscosity of exemplary hard molded lozenges comprising fructooligosaccharide or fructo-oligosaccharide and inulin as a function of glycerin concentration.
  • Figure 5 is a graph showing the change in dissolution time of exemplary hard molded FOS lozenges with increasing concentrations of glycerin, various exemplary hard molded FOS: Inulin lozenges, exemplary hard molded inulin:glycerin lozenges and comparative traditional sugar candy formulations,
  • Figure 6 is a graph showing the increase in dissolution time of FOS lozenges with increasing amounts of inulin.
  • oligosaccharide As used in this application, the singular forms “a”, “an” and “the” include plural references unless the content clearly dictates otherwise. For example, an embodiment including “a oligosaccharide” should be understood to present certain aspects with one oligosaccharide or two or more oligosaccharides.
  • suitable means that the selection of the particular compound or conditions would depend on the specific synthetic manipulation to be performed, and the identity of the species to be transformed, but the selection would be well within the skill of a person trained in the art. All method steps described herein are to be conducted under conditions sufficient to provide the desired product. A person skilled in the art would understand that all reaction conditions, including, for example, reaction solvent, reaction time, reaction temperature, reaction pressure, reactant ratio and whether or not the reaction should be performed under an anhydrous or inert atmosphere, can be varied to optimize the yield of the desired product and it is within their skill to do so.
  • subject as used herein includes all members of the animal kingdom including mammals, and suitably refers to humans. Thus the methods and uses of the present application are applicable to both human therapy and veterinary applications.
  • the term “effective amount” or “therapeutically effective amount” means an amount of a compound, or one or more compounds of the application that is effective, at dosages and for periods of time necessary to achieve the desired result.
  • cannabinoid refers to one of a group of compounds that acts on cannabinoid receptors.
  • cannabinoid extract refers to any extract from a cannabis plant comprising one or more cannabinoids.
  • pill refers a solid or semi-solid buccal dosage form that is dissolvable in the mouth.
  • hard molded lozenge refers to a lozenge having rigid structure that will not deform once biting pressure is applied, and may split into pieces once biting pressure is sufficient to break the rigid structure.
  • soft chew lozenge refers to a lozenge having a structure that is deformable under biting pressure.
  • buccal dosage form refers to a dosage form that is generally intended to be held in the mouth and used to deliver an active compound through one or more membranes in the buccal cavity, including the buccal mucosa, buccal gingiva, mucous membrane of the tongue, sublingual membrane and the soft palate.
  • the term encompasses all suitable solid and semi-solid dosage forms.
  • a buccal form may be swallowed if so desired by a user.
  • polysaccharide refers to a saccharide comprising two or more monosaccharide units joined by glycosidic bonds and having various degrees of polymerization.
  • the term encompasses heterogenous mixtures of polysaccharides having various degrees of polymerization and also encompasses polysaccharides, such as those polysaccharides obtained from natural sources, and which may comprise polysaccharides having various degrees of polymerization and may also comprise some amount of oligosaccharides and/or heterogeneous mixtures of oligosaccharides.
  • polysaccharides refers to polysaccharides having an average degree of polymerization of about 9 or greater.
  • oligosaccharide refers to a saccharide comprising two or more monosaccharide units joined by glycosidic bonds and having a degree of polymerization of about 10 or less.
  • the term encompasses heterogenous mixtures of oligosaccharides having various degrees of polymerization of about 10 or less.
  • saccharide refers to a carbohydrate comprising monosaccharides, disaccharides, oligosaccharide, and/or polysaccharides.
  • inulin refers to a heterogeneous mixture of polysaccharides having various molecular weights or degrees of polymerization.
  • Inulin belongs to a class of fibres known as fructans and generally comprises fructose units with beta 1-2 bonds which may end in a glucose unit and generally comprises a relatively high degree of polymerization.
  • the term encompasses raw inulin obtained from natural sources and fractions of inulin.
  • inulin comprising heterogenous mixtures of polysaccharides having various average degrees of polymerization and also encompasses inulin which may comprise polysaccharides having various average degrees of polymerization and may also comprise some amount of naturally occurring oligosaccharides or mixtures of oligosaccharides.
  • Inulin as used herein refers to inulin having an average degree of polymerization of about 9 or greater.
  • degree of polymerization refers to the number of monosaccharide residues present in an oligo- or polysaccharide.
  • the degree of polymerization is a measure of molecular weight (MW) and can be calculated as the ratio of the total MW of the polymer or oligomer and the MW of the repeating units.
  • average degree of polymerization refers to the mean of the degree of polymerization of all the molecules present in the oligo- or polysaccharide.
  • a saccharide with a DP in a certain range may include a mixture of saccharides with different average DPs.
  • FOS oligosaccharide
  • oligofructose refers to an oligosaccharide generally comprising fructose units linked by a glycosidic bond which may end in a glucose unit.
  • FOS may be obtained by partial hydrolysis or by physical separation of inulin obtained from plant sources or FOS may be enzymatically synthesized from sucrose.
  • galacto-oligosaccharide refers to an oligosaccharide generally comprising galactose units linked by a glycosidic bond.
  • glycolin or “glycerol” or “glycerine” as used herein refers to a compound having the ILJPAC name: propane-1 , 2, 3-triol, and having the chemical formula
  • % (w/w) or “weight percent” as used herein means, unless otherwise noted, the ratio of the mass of one component of a composition compared to the mass on a dry solids basis of the entire buccal dosage form.
  • Buccal dosage forms such as hard molded lozenge, soft chew lozenges, and compressed tablets comprising one or more cannabinoid and/or cannabinoid extracts and one or more oligosaccharides such as fructo-oligosaccharide alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin have been prepared.
  • Buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer such glycerin have also been prepared.
  • the buccal dosage forms have been prepared without any added sugars, sweeteners, or sweetening agents
  • a challenge in manufacturing buccal dosage forms without any added sugars, sweeteners, or sweetening agents is to provide a buccal dosage form that tastes and performs comparably to a buccal dosage forms comprising sugar.
  • Oligosaccharides such as fructooligosaccharide and polysaccharides such as inulin are not as sweet as sugar.
  • Oligosaccharides such as fructo-oligosaccharide have about 30% (w/w) to 50% the sweetness of sugar, while inulin has only about 10% the sweetness of sugar.
  • formulations comprising a cannabinoid such as tetrahydrocannabinol (THC) are known to provide a bitter taste with unpleasant “grassy” notes, particularly in the case of lower-purity cannabinoid extracts, which contains within it various waxes, flavonoids, and/or other plant compounds.
  • a cannabinoid such as tetrahydrocannabinol (THC)
  • THC tetrahydrocannabinol
  • the Applicant has found that the buccal dosage forms of the application comprising one or more oligosaccharides such as fructo-oligosaccharide alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin, or comprising one or more polysaccharides such as inulin and a plasticizer such glycerin have a sufficiently sweet and pleasant flavour and “mouth-feel” without any added sugars, sweeteners, or sweetening agents.
  • high potency dosage forms of the application such as hard molded lozenges comprising, for example, up to 10mg of THC.
  • the buccal dosage forms of the application have also been found to have a dissolution profile comparable to that of buccal dosage forms comprising sugar. Further, the rate of dissolution of the buccal dosage forms such as the hard molded lozenge dosage forms can be adjusted (e.g increased) by the addition of a plasticizer such as glycerin. Therefore, the Applicant has advantageously found the rate of dissolution of the hard molded lozenge dosage can be modulated by varying the amount of a plasticizer such as glycerin added to the dosage form.
  • a plasticizer such as glycerin was also found to advantageously decrease the temperature of solidification of the bulk lozenge product in the preparation of the hard molded lozenge dosage forms thereby increasing the efficiency and workability of the manufacturing process. Decreasing the temperature of solidification increases the time available to work the bulk lozenge product to provide the individual hard molded lozenges.
  • the Applicant has surprisingly found that the buccal dosage forms of the application comprising one or more oligosaccharides such as fructo-oligosaccharide alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin, or buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer such glycerin both provide both a satisfying tactile or “mouth feel” and/or a pleasant flavor experience and excellent manufacturing workability and moldability without added sugars, sweeteners, or sweetening agents.
  • oligosaccharides such as fructo-oligosaccharide alone or in combination with one or more polysaccharides such as inulin
  • a plasticizer such as glycerin
  • the addition of a plasticizer such as glycerin to the hard molded lozenge dosage forms provides a favourable and controllable rate of dissolution, low resulting viscosity in solution, a controllable temperature and rate of solidification and improved moldability, without added sugars, sweeteners, or sweetening agents.
  • the buccal forms of the application provide surprising advantages in reclaiming rework from the manufacturing process of the buccal dosage forms such as hard lozenge buccal dosage forms.
  • Rework refers to the scrap or unused product from one manufacturing batch that that is subsequently used and/or incorporated into the next manufacturing batch.
  • rework is reclaimed by being ground up and added to the next batch or by being ground up, filtered, and put into solution using specialized and costly rework reclamation equipment.
  • only about 2-5% of rework can be used in each subsequent batch in the first manner while about 10% of rework can be used in each subsequent batch by the second process.
  • rework resulting form the preparation of the hard lozenge buccal dosage forms of the application can be simply and efficiently reheated and remolded or incorporated into a single new batch with essentially no loss of product. Maximizing the usability of rework without needing to distribute such rework in stages across multiple subsequent batches is very advantageous as it affects both quality of product and costs. For example, the ability to reheat and re-process rework in isolation, without needing to mix across subsequent batches minimizes loss, maintains active pharmaceutical ingredient tracking, controls input variation across lots, and mitigates cross contamination risk.
  • Minimizing the amount of rework and having further control over product variability is also particularly advantageous when using high cost and highly regulated actives such as cannabinoids and/or cannabinoid extracts (e.g., cannabinoid distillates and infusions).
  • actives such as cannabinoids and/or cannabinoid extracts (e.g., cannabinoid distillates and infusions).
  • oligosaccharides such as fructo-oligosaccharide or galacto-oligosaccharide are non-digestible oligosaccharides.
  • Non-digestible oligosaccharides are known to have many health benefits.
  • the one or more non-digestible oligosaccharides is a prebiotic and/or a soluble fibre. Soluble fibre dissolves in ambient water and can attract water and form a gel. Soluble fibre can slow down digestion and delay the emptying of a stomach. Therefore, the one or more non-digestible oligosaccharides contributes to the dietary fibre fraction of the diet and/or a feeling of satiety.
  • the one or more non-digestible oligosaccharides have a reduced calorie content and a lower glycemic index compared to sucrose (table sugar).
  • the soft chew lozenge forms comprising one or more oligosaccharides such as fructo-oligosaccharide were found to be surprisingly stable.
  • the humectant properties of the one or more oligosaccharides help maintain moisture levels and lower water activity thereby contributing to restraining microorganism development and to lengthening shelf-life.
  • a buccal dosage form comprising:
  • the buccal dosage form is a solid or semi-solid form.
  • the buccal dosage form is suitable for chewing, sucking, buccal dissolution or swallowing.
  • a person of skill in the art would appreciate that a subject may choose to swallow the buccal dosage form.
  • the choice of chewing, sucking, buccal dissolution or swallowing may be at the discretion of the subject.
  • the buccal dosage form is intended to be held in the mouth of a subject.
  • the buccal dosage form is suitable for sucking or buccal dissolution.
  • the buccal dosage form dissolves in a subject's mouth by passive incubation in the oral cavity, or actively by sucking or mastication to deliver the one or more cannabinoids, and/or a cannabinoid extract to the oral cavity and esophagus. In an embodiment, the buccal dosage form dissolves in a subject's mouth by passive incubation in the oral cavity, or actively by sucking to deliver the one or more cannabinoids, and/or a cannabinoid extract to the oral cavity and esophagus. In an embodiment, the buccal dosage form is a sublingual dosage form.
  • the buccal dosage form is a lozenge.
  • the lozenge is a hard molded lozenge, soft chew lozenge, compressed tablet lozenge, a soft lozenge, troche, cachou, pill, capsule, tab, a pellet, a dragee or a pastille.
  • the lozenge is a hard molded lozenge, compressed tablet lozenge or a soft chew lozenge.
  • the lozenge is a hard molded lozenge or compressed tablet lozenge.
  • the lozenge is a hard molded lozenge.
  • the buccal dosage form comprises about 10% (w/w) to about 99.9% (w/w), about 15% (w/w) to about 99.9% (w/w), about 20% (w/w) to about 99.9% (w/w), about 25% (w/w) to about 99.9% (w/w), about 30% (w/w) to about 99.9% (w/w), about 35% (w/w) to about 99.9% (w/w), about 40% (w/w) to about 99.9% (w/w), about 45% (w/w) to about 99.9% (w/w), about 50% (w/w) to about 99.9% (w/w), about 55% (w/w) to about 99.9% (w/w), about 60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to about 99.9% (w/w/w), about 10% (
  • the buccal dosage form comprises about 10% (w/w) to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about 95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 40% (w/w) to about 60% (w/w), about 45% (w/w) to about 50% (w/w), about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about 50% (w/w),
  • the buccal dosage form comprises about 10% (w/w), about 15% (w/w), about 20% (w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w), about 45% (w/w), about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w), about 80% (w/w), about 85% (w/w), about 90% (w/w), about 95% (w/w), about 96% (w/w), about 97% (w/w), about 98% (w/w), about 99% (w/w) or about 99% (w/w) or about 99% (w/w) or about 99% (w/w) or more of the one or more oligosaccharides.
  • a buccal dosage form comprising:
  • the buccal dosage form is comprised primarily of the one or more oligosaccharides. In an embodiment, the buccal dosage form comprises more than about 70% of the one or more oligosaccharides having a degree of polymerization of about 10 or less.
  • the present application also includes a buccal dosage form comprising:
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6, or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the one or more oligosaccharides are selected from digestible oligosaccharides and non-digestible oligosaccharides and combinations thereof.
  • the one or more oligosaccharides are one or more digestible oligosaccharide. In an embodiment, the one or more oligosaccharides is malto-oligosaccharide.
  • the one or more oligosaccharides are one or non-digestible oligosaccharide.
  • the one or more non-digestible oligosaccharides is a prebiotic.
  • the one or more non-digestible oligosaccharides is a soluble fibre. Soluble fibre dissolves in ambient water and can attract water and form a gel. Soluble fibre can slowdown digestion and delay the emptying of a stomach. Therefore, in an embodiment, the one or more non-digestible oligosaccharides contributes to the dietary fibre fraction of the diet and/or a feeling of satiety. In an embodiment, the one or more non-digestible oligosaccharides have a reduced calorie content and a lower glycemic index compared to sucrose (table sugar).
  • the one or more oligosaccharides are selected from one or more oligosaccharides comprising one type of sugar monomer, and one or more oligosaccharide comprising one two or more different types of sugar monomers and combinations thereof.
  • the one or more non-digestible oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), gluco-oligosaccharides arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto- oligosaccharides (IMO), raffinose family of oligosaccharides (RFO), gluco-galacto- oligosaccharides, gluco-fructo-oligosaccharides, gluco-manno-oligosaccharides, gluco-arabino- oligosaccharides, gluco-xylo-oligosaccharides, galacto-fructo-oligosaccharides, galacto-manno- oligosaccharides, galacto-arabino-oligosaccharides,
  • the one or more non-digestible oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabinooligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more non-digestible oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more non-digestible oligosaccharides is fructo-oligosaccharides (FOS).
  • the galacto-oligosaccharides are selected from transgalactooligosaccharides (TGOS) and beta-galacto-oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are commercially available or can be prepared by methods known in the art.
  • fructo-oligosaccharides are produced by the partial enzymatic hydrolysis from inulin from natural sources such as from chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana, or agave or the FOS is produced by the partial enzymatic hydrolysis from chicory inulin.
  • FOS is prepared by enzymatic synthesis with sucrose by methods known in the art, for example, by the transfructosylation of sucrose by p-fructofuranosidases.
  • fructooligosaccharides are commercially available under the tradenames Orafti® Oligofructose from Beneo GmbH New Jersey, U.S.A) and Fossence ® by Tata NQ (Maharashtra, India), galacto-oligosaccharides are commercially available under the tradenames Ariya Purity® GOS by Ariya Health (Queensland, Australia) and isomalto-oligosaccharides are commercially available under the tradename IMO Fibre® by Nutra Food ingredients (Michegan, U.S.A).
  • the FOS is Orafti® Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the buccal dosage forms of the application comprising one or more oligosaccharides alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin, or buccal dosage forms comprising one or more polysaccharides such as inulin and a plasticizer such glycerin provide a satisfying tactile or “mouth feel” and/or a pleasant flavor experience without added sugars, sweeteners, or sweetening agents.
  • the buccal dosage forms of the present application are free of added sugars, sweeteners, and/or sweetening agents.
  • the one or more oligosaccharides having a degree of polymerization (DP) of, for example, about 10 or less comprise a heterogenous mixture of oligosaccharides of different DPs.
  • the fructo-oligosaccharide having a DP of about 10 or less comprises a heterogenous mixture of oligosaccharides of different DPs of about 10 or less including, for example, kestose, nystose, fructosylnystose, bifurcose, inulobiose (two D-fructose residues linked together or fructo-oligosaccharide having a DP of 2), inulotriose (three D-fructose residues linked together or fructo-oligosaccharide having a DP of 3), and inulotetraose (four D- fructose residues linked together or fructo-oligosaccharide having a DP of 4).
  • the one or more oligosaccharides having a DP of about 10 or less also comprise sugars (i.e. , monosaccharides and/or disaccharides) as natural components of the one or more oligosaccharides having a DP of about 10 or less. Accordingly, in an embodiment, the one or more oligosaccharides having a DP of, for example, about 10 or less comprise naturally occurring sugars (i.e., monosaccharides and/or disaccharides).
  • the one or more oligosaccharides having a DP of, for example, about 10 or less comprise naturally occurring monosaccharides and/or disaccharides resulting, for example, from the isolation or manufacturing process of the one or more oligosaccharides.
  • the one or more oligosaccharides comprise about 45% (w/w) or less, about 40%(w/w) or less, about 30%(w/w) or less, about 20%(w/w) or less, about 15% (w/w) or less, about 10% (w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w), about 2%(w/w) or less, or about 1%(w/w) or less of the monosaccharides and/or disaccharides on a dry solid basis of the total weight of the one or more oligosaccharides.
  • the one or more oligosaccharides comprise about 15% (w/w) or less, about 10% (w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the one or more oligosaccharides.
  • the one or more oligosaccharides comprise about 40% (w/w) or less, about 30%(w/w) or less, about 15% (w/w) or less, about 10% (w/w) or less, about 8%(w/w) or less, about 5%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the one or more oligosaccharides.
  • the one or more oligosaccharides comprise about 5%(w/w) or less of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the one or more oligosaccharides.
  • the one or more oligosaccharides comprise about 0.1 % (w/w) to about 40 % (w/w), about 0.1 % (w/w) to about 35 % (w/w), about 0.1 % (w/w) to about 30 % (w/w), about 0.1 % (w/w) to about 25 % (w/w), about 0.1 % (w/w) to about 20 % (w/w), about 1 % (w/w) to about 40 % (w/w), about 1 % (w/w) to about 35 % (w/w), about 1 % (w/w) to about 30 % (w/w), about 1 % (w/w) to about 25 % (w/w), about 1 % (w
  • the one or more oligosaccharides comprise about 0.1 % (w/w) to about 10% (w/w), about 0.25 % (w/w) to about 10% (w/w), about 1% (w/w) to about 10% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.25 % (w/w) to about 5% (w/w), about 1% (w/w) to about 5% (w/w), about 0.1 % (w/w) to about 3% (w/w), about 0.25 % (w/w) to about 3% (w/w), about 1% (w/w) to about 3% (w/w), about 0.1 % (w/w) to about 2% (w/w), about 0.25 % (w/w) to about 2% (w/w), about 1% (w/w) to about 2% (w/w), about 1% (w/w) to about 2% (w/w), about 1% (w/w)
  • the one or more oligosaccharides comprise about 1% (w/w) to about 10% (w/w), about 1% (w/w) to about 8% (w/w), or about 1 % (w/w) to about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the one or more oligosaccharides.
  • fructo-oligosaccharide having a DP of about 10 or less comprises a heterogenous mixture of oligosaccharides of different DPs including, for example, kestose, nystose, fructosylnystose, bifurcose, inulotriose, inulotetraose and inulobiose.
  • Inulobiose is composed of two D-fructose residues linked together (i.e., fructo-oligosaccharide having a DP of 2) and is a disaccharide.
  • inulobiose is both a sugar (i.e., disaccharide) and an oligosaccharide (i.e., fructo-oligosaccharide of DP of 2) and can be categorized as either a sugar or an oligosaccharide.
  • oligosaccharide i.e., fructo-oligosaccharide of DP of 2
  • inulobiose would be appreciated by a person skilled in the art, see for example, Cummings, J., Stephen, A. Carbohydrate terminology and classification. Eur J Clin NutrQ , S5-S18 (2007), and Marcel B. Roberfroid, Inulin-Type Fructans: Functional Food Ingredients, The Journal of Nutrition, Volume 137, Issue 11, November 2007, Pages 2493S-2502S.
  • inulobiose as either a fibre (i.e., oligosaccharide) or a sugar.
  • Health Canada considers a dietary fibre to consist of, for example, carbohydrates with a DP of 3 or more that naturally occur in foods of plant origin and that are not digested and absorbed by the small intestine
  • the Australian food agency considers the term dietary fibre to comprise, for example, oligosaccharides with a DP of greater than 2, while manufacturers of oligosaccharides such as Beneo GmbH New Jersey (Orafti® Oligofructose) generally define inulobiose as a dietary fiber (e.g. oligosaccharide) and make note that regulatory agencies may require inulobiose to be considered a sugar.
  • fructo-oligosaccharide comprising a DP of 2, for example, as in a DP of about 2 to about 10 or less, is considered to include inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide is fructooligosaccharide having a DP of 2).
  • fructo-oligosaccharide having a DP of, for example, 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is an oligosaccharide having a DP of 2.
  • fructooligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a heterogenous mixture of oligosaccharides of different DPs of about 2 to about 10 or less including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) not including inulobiose.
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component described above is fructo-oligosaccharide having a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to about 9 or about 3 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is included as a component of the naturally occurring sugars in the fructo-oligosaccharide.
  • fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component is fructooligosaccharide having a DP of about 3 to about 10 or less which comprises a heterogenous mixture of oligosaccharides of different DPs of about 3 to about 10 or less not including inulobiose and comprises naturally occurring sugars ( i.e. , monosaccharides and/or disaccharides) including inulobiose.
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 8% (w/w), about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 % (w/w) to about 7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7% (w/w), about 0.1 % (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 % (w/w) to about 6% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5% (w/w), about 1 % (w/w) to about 1 % (w/
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises 0.1 % (w/w) to about 4% (w/w), about 1 % (w/w) to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to about 3% (w/w), of inulobiose on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • “free of added sugars, sweeteners and/or sweetening agents” and the like means that the buccal dosage form does not comprise sugars, sweeteners and/or sweetening agents that are added in addition to the one or more oligosaccharides and any monosaccharides and/or disaccharides that may be naturally present in the one or more oligosaccharides as described above or in addition to any monosaccharides and/or disaccharides that may be naturally present in any other additive in the buccal dosage form, including but not limited to, polysaccharides, emulsifying agents, oils and/or fats, gelling agents, lubricants, plasticizers, flavouring agents or pH modifying agents as described below, and those naturally present monosaccharides and/or disaccharides are present at levels that are not above the naturally occurring level for each of the additives.
  • the sugars, sweeteners and sweetening agents are sugars, sweeteners and sweetening agents as defined in section B.01.001 (1 ) of the Food and Drug Regulations C.R.C., c. 870 (2020).
  • the sugars are selected from monosaccharides and disaccharides and combinations thereof.
  • the monosaccharides and disaccharides are selected from glucose, fructose, sucrose, galactose, ribose, lactose, and maltose and combinations thereof.
  • the disaccharide is inulobiose. Accordingly, in an embodiment, the buccal dosage form does not comprise inulobiose that is added in addition to the inulobiose occurring as a natural component in the fructo-oligosaccharide as described above.
  • section B.01.001 (1 ) of the Food and Drug Regulations C.R.C., c. 870 (2020) defines sweetener as any sweetener referred to in section 2 of the Marketing Authorization for Food Additives That May Be Used as Sweeteners (SOR/2012-210).
  • Section 2 of the Marketing Authorization for Food Additives That May Be Used as Sweeteners refers to sweeteners as defined in the List of Permitted Sweeteners published by the Department of Health of Canada.
  • the sweeteners are sweeteners as referred to section 2 of the Marketing Authorization for Food Additives That May Be Used as Sweeteners (SOR/2012-210) and defined in column 1 of the List of Permitted Sweeteners published by the Department of Health of Canada.
  • the sweeteners are selected from aspartame, ascesulfame potassium, advantame, erythritol, saccharin, including calcium saccharin, potassium saccharin, sodium saccharin, hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, maltitol syrup, mannitol, monk fruit extract, neotame, sorbitol, sorbitol syrup, stevia, steviosides, steviol glycosides from Stevia rebaudiana Bertoni, steviol glycosides from Saccharomyces cerevisiae CD15380, steviol glycosides from Saccharomyces cerevisiae CD15407, sucralose, thaumatin, and xylitol, and combinations thereof.
  • section B.01.001 (1 ) of the Food and Drug Regulations C.R.C., c. 870 (2020) defines sweetening agent as any food for which a standard is provided in Division 18 of the Food and Drug Regulations C.R.C., c. 870 (2020) but not including those food additives listed in the tables to Division 16 of the Food and Drug Regulations C.R.C., c. 870 (2020).
  • the sweetening agent is selected from any food for which a standard is provided in Division 18 of the Food and Drug Regulations C.R.C., c. 870 (2020) but not including those food additives listed in the tables to Division 16 of the Food and Drug Regulations C.R.C., c.
  • the sweetening agent is selected from table sugar, liquid sugar, invert sugar, liquid invert sugar, icing sugar, brown sugar, yellow sugar, golden sugar, refined sugar syrup, refiners’ syrup, golden syrup, fancy molasses, table molasses, refiners’ molasses, blackstrap molasses, cooking molasses, dextrose anhydrous, dextrose monohydrate, glucose, glucose syrup, glucose solids, dried glucose syrup, syrup, lactose, and honey and combinations thereof.
  • the cannabinoid extract is a crude or purified extract from a cannabis plant.
  • the cannabinoid extract is obtained from a cannabis plant by supercritical CO2 extraction, subcritical CO2 extraction, or organic solvent extraction such as hydrocarbon extraction or ethanol extraction, and water extraction.
  • the cannabinoid extract is obtained from a cannabis plant without solvent such as by using a mechanic press, a hydraulic separator, or a sieve.
  • the cannabinoid extract is a dry sift.
  • the cannabinoid extract is isolated trichomes.
  • the cannabinoid extract is selected from kief, hash such as drysift hash or bubble hash, butane, hash oil, shatter, budder, honeycomb, crumble, sap, RSO (Rick Simpson Oil), rosin, and resin and combinations thereof.
  • the cannabinoid extract obtained from a cannabis plant is purified.
  • the cannabinoid extract is purified by dewaxing.
  • the cannabinoid extract is purified by fractional distillation.
  • the cannabinoid extract is a cannabinoid distillate.
  • the cannabinoid distillate is the product of short path distillation, spinning band distillation, wiped film distillation, or falling film distillation.
  • the cannabinoid extract is purified by chromatography and solvent crystallization.
  • the chromatography is centrifugal partition chromatography.
  • the cannabinoid extract is purified such that one or more cannabinoid is present at greater than 60% (w/w), greater than 70% (w/w), greater than 80% (w/w), greater than 85% or greater than 95% of the total extract (w/w). In an embodiment, the cannabinoid extract is purified such that one or more cannabinoid is present greater than 85% or greater than 95% of the total extract (w/w). In an embodiment, the cannabinoid extract is purified such that one or more cannabinoid is present at greater than 95% of the total extract (w/w). In an embodiment, the cannabinoid extract is purified such that one or more cannabinoid is present at greater than 98% of the total extract (w/w).
  • the one or more cannabinoids are selected from one of more of cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabidivarinic acid (CBDVA), cannabigerol (CBG), cannabigerol acid (CBGA), cannabigerol propyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabitriol (CBT), cannabichromenic acid (CBCA), cannabidiphorol (CBDP), cannabidiphorolic acid (CBDPA), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabipgorolic acid (
  • the one or more cannabinoids are synthetic. In an embodiment, the one or more cannabinoids are obtained through biofermentation methods or other biogenerating methods. In an embodiment, the biofermentation method is a yeast biofermentation method.
  • the present application includes a buccal dosage form comprising one or more cannabinoids, and/or a cannabinoid extract as described above.
  • the present application includes a buccal dosage form comprising one or more cannabinoids as described above.
  • the present application includes a buccal dosage form comprising one or more cannabinoid extracts as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations.
  • the one or more cannabinoids is THC.
  • the buccal dosage form of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoids in the cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the buccal dosage form comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the buccal dosage form comprises THC and CBD, and the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the buccal dosage form comprises 10mg of THC and 2mg of CBD.
  • the buccal dosage form comprises equal amounts of THC and CBD.
  • the buccal dosage form comprises 5mg of THC and 5mg of CBD.
  • the buccal dosage form comprises 2.5mg of THC and 2.5mg of CBD.
  • the buccal dosage form comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the cannabinoid extract is purified such that one or more cannabinoid is present at greater than about 80% (w/w), greater than about 85% or greater than about 95% of the total extract (w/w).
  • the buccal dosage form comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about.1 mg to about 1 mg of THC.
  • the cannabinoid extract comprises about 0.1 mg to about 10 mg of THC.
  • the buccal dosage form comprises about 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg of THC.
  • the Applicant has prepared a hard molded lozenge comprising about 1% (w/w) of a cannabinoid extract that comprises about 10mg of THC, the Applicant has prepared a high potency buccal dosage form. Therefore, in an embodiment, the buccal dosage form is a high potency buccal dosage form. Accordingly, in an embodiment, the present application includes high potency buccal dosage forms.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 :900 to about 1 :5, about 1 :800 to about 1:5, about 1 :700 to about 1 :5, about 1 :600 to about 1:5, about 1 :500 to about 1 :5, about 1 :400 to about 1:5, about 1 :300 to about 1:5, about 1 :200 to about 1 :5, about 1 :150 to about 1 :5, about 1: 100 to about 1 :5, about 1 :50 to about 1:5, of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the buccal dosage form optionally further comprises one or more polysaccharides.
  • the one or more polysaccharides have a degree of polymerization of up to about 80 and have an average degree of polymerization of about 9 or greater.
  • the added % (w/w) of the one or more polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides in the buccal dosage form.
  • replaces an equal % (w/w) of the one or more oligosaccharides it is meant that the combined amount of the one or more oligosaccharides and the one or more polysaccharides in the buccal dosage form is the same as the total amount of the one or more oligosaccharides in an otherwise identical buccal dosage form except for the absence one or more the one or more polysaccharides.
  • the one or more polysaccharides having a degree of polymerization of up to about 80 and having an average degree of polymerization of about 9 or greater may comprise a heterogenous mixture of polysaccharides having various degrees of polymerization up to about 80 and having an average degree of polymerization of about 9 or greater. It would also be appreciated by a person skilled in the art that the one or more polysaccharides may also comprise oligosaccharides or a mixture of oligosaccharides. In an embodiment, the oligosaccharides or mixture of oligosaccharides are naturally occurring in the one or more polysaccharides, and for example, result from the isolation or manufacturing process.
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the buccal dosage form comprises about 0.1% (w/w) to about 89.9% (w/w), about 0.5% (w/w) to about 89.9% (w/w), about 1% (w/w) to about 89.9% (w/w), about 5% (w/w) to about 89.9% (w/w), about 10% (w/w) to about 89.9%(w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about 89.9%(w/w), about 30% (w/w) to about 89.9% (w/w), about 35% (w/w) to about 89.9% (w/w), about 40% (w/w) to about 89.9%(w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w) to about 89.9% (w/w), about
  • the buccal dosage form comprises about 0.1% (w/w) to about 80% (w/w), about 0.1% (w/w) to about 75% (w/w), about 0.5% (w/w) to about 80% (w/w), about 1% (w/w) to about 80% (w/w), about 5% (w/w) to about 80% (w/w), about 10% (w/w) to about 80%(w/w), about 15% (w/w) to about 80% (w/w), about 20% (w/w) to about 80% (w/w), about 25% (w/w) to about 80%(w/w), about 30% (w/w) to about 80% (w/w), about 35% (w/w) to about 80% (w/w), about 40% (w/w) to about 80%(w/w), about 45% (w/w) to about 80% (w/w), about 50% (w/w) to about 80% (w/w), about 55% (w/w) to about
  • the buccal dosage form comprises about 0.1 % (w/w) to about 88 % (w/w), about 0.5% (w/w) to about 88% (w/w), about 1% (w/w) to about 88% (w/w), about 5% (w/w) to about 88% (w/w), about 10% (w/w) to about 88%(w/w), about 15% (w/w) to about 88% (w/w), about 20% (w/w) to about 88% (w/w), about 25% (w/w) to about 88%(w/w), about 30% (w/w) to about 88% (w/w), about 35% (w/w) to about 88% (w/w), about 40% (w/w) to about 88%(w/w), about 45% (w/w) to about 88% (w/w), about 50% (w/w) to about 88% (w/w), about 55% (w/w) to about 88%(w/w), about 60% (w/w/w/w
  • the buccal dosage form comprises about 0.1% (w/w) to about 89.9% (w/w), about 0.5% (w/w) to about 89.9% (w/w), about 1% (w/w) to about 89.9% (w/w), about 5% (w/w) to about 89.9% (w/w), about 10% (w/w) to about 89.9%(w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about 89.9%(w/w), about 30% (w/w) to about 89.9% (w/w), about 35% (w/w) to about 89.9% (w/w), about 40% (w/w) to about 89.9%(w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w)
  • the buccal dosage form comprises about 0.1% (w/w) to about 88.9% (w/w), about 0.1% (w/w) to about 80% (w/w), about 0.1 % (w/w) to about 60% (w/w), about 0.
  • the buccal dosage form comprises about 70% (w/w) to about 97.9% (w/w), about 75% (w/w) to about 97.9% (w/w), about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w), about 97% (w/w) to about 97.9% (w/w) of one or more oligosaccharides.
  • the buccal dosage form comprises about 10% (w/w) to about 89.9% (w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about 89.9% (w/w), about 30% (w/w) to about 89.9% (w/w), about 40 (w/w) to about 89.9% (w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w) to about 89.9% (w/w), about 55% (w/w) to about 89.9% (w/w), about 65% (w/w) to about 89.9% (w/w), about 70% (w/w) to about 89.9% (w/w), about 75% (w/w) to about 89.9% (w/w), about 80% (w/w) to about
  • the buccal dosage form comprises about 1% (w/w), about 5% (w/w), about 10% (w/w), about 15% (w/w), about 20% (w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w), about 45% (w/w), about 50% (w/w), about 55% (w/w), about 60% (w/w), about 65% (w/w), about 70% (w/w), about 75% (w/w), about 80% (w/w), about 85% (w/w), or about 89% (w/w) of one or more polysaccharides.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 99.9 % (w/w) of the buccal dosage form.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to about 99.9% (w/w), about 80% (w/w) to about 99.9% (w/w), about 85% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w) .
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 89.9% (w/w) to about 98% (w/w), about 95% (w/w) to about 98% (w/w), about 97% (w/w) to about 98% (w/w), or about 98% (w/w) to about 98% (w/w) of the buccal dosage form.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w), about 60% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or about 85% (w/w) to about 90% (w/w), about 90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w) or about 90% (w/w) to about 95% (w/w) of the total weight of the buccal dosage form.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 80% (w/w), about 60% (w/w) to about 70% (w/w), about 90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w) or about 90% (w/w) to about 95% (w/w) of the total weight of the buccal dosage form.
  • the one or more polysaccharides are selected from modified starches, maltodextrin, polydextrose, fructans, glucans, xylans and galactans and combinations thereof.
  • the one or more polysaccharides are fructans.
  • the one or more polysaccharides is inulin.
  • the buccal dosage form comprises about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater.
  • the buccal dosage comprises about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater, wherein the one or more oligosaccharides and the inulin combined comprise about 55% (w/w) to about 99.9% (w/w) of the buccal dosage form.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60 or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater. In an embodiment, inulin is commercially available, for example, under the trade name Orafti® inulin by Beneo Inc. (New Jersey, U.S.A).
  • the one or more cannabinoids, and/or a cannabinoid extract, the one or more oligosaccharides and the one or more polysaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 :900 to about 1:5, about 1 :800 to about 1 :5, about 1 :700 to about 1 :5, about 1:600 to about 1 :5, about 1 :500 to about 1 :5, about 1 :400 to about 1 :5, about 1 :300 to about 1 :5, about 1 :200 to about 1:5, about 1 :150 to about 1 :5, about 1 :100 to about 1 :5, about 1 :50 to about 1 :5 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides and the one or more polysaccharides combined.
  • the one or more cannabinoids, and/or a cannabinoid extract, the one or more oligosaccharides and the one or more polysaccharides are present in a weight ratio of about 1: 1000 to about 1 :5, about 1 :1000 to about 1 :100, about 1:1000 to about 1:200, about 1 :1000 to about 1 :300, about 1 :1000 to about 1:400, about 1 :1000 to about 1 :500, about 1 :1000 to about 1 :600, or about 1 :1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides and the one or more polysaccharides combined.
  • the one or more cannabinoids, and/or a cannabinoid extract, the one or more oligosaccharides are present in a weight ratio of about 1 :900 to about 1 :5, about 1 :800 to about 1 :5, about 1 :700 to about 1 :5, about 1 :600 to about 1:5, about 1 :500 to about 1 :5, about 1:400 to about 1 :5, about 1 :300 to about 1 :5, about 1 :200 to about 1:5, about 1 :150 to about 1 :5, about 1 :100 to about 1 :5, about 1 :400 to about 1 :50, about 1 :400 to about 1 :100, about 1 :300 to about 1 :100, about 1 :300, about 1 :200, about 1 : 150 or about 1 : 100 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides and the one or more polysaccharides
  • the buccal dosage form optionally further comprises one or more additives selected from plasticizers, emulsifying agents, oils and/or fats, flavourants, gelling agents, pH modifying agents and lubricants.
  • the buccal dosage form when the buccal dosage form is, for example, a hard molded lozenge, the buccal dosage form optionally further comprises one or more plasticizers.
  • the buccal dosage form comprises about 2 % (w/w) to about 15% (w/w), about 2 % (w/w) to about 12% (w/w), about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the plasticizer.
  • the buccal dosage form comprises about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizer.
  • the lozenge comprises about 5% (w/w) of the plasticizer.
  • the one or more plasticizers is selected from glycerin and polyethylene glycol and combinations thereof. In an embodiment, the one or more plasticizers is glycerin. [00131] In an embodiment, the buccal dosage form optionally further comprises one or more emulsifying agents.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, about 5%(w/w) or less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less, about 9% (w/w) or less, or about 10% (w/w) or less of an emulsifying agent.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
  • the buccal dosage form comprises about 0.1 % (w/w) to about 5% (w/w), about 0.1 % (w/w) to about 4% (w/w), about 0.1 % (w/w) to about 3% (w/w), about 0.1 % (w/w) to about 2% (w/w), about 0.1 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), about 1 % (w/w) to about 2% (w/w) of the one or more emulsifying agents.
  • the buccal dosage form further comprises from about 0.5% (w/w) to about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w) of the one or more emulsifying agents.
  • the buccal dosage form comprises about 0.1 % (w/w) to about 2% (w/w), or about 0.1 % (w/w) to about 1% (w/w) of the one or more emulsifying agents.
  • the buccal dosage form optionally comprises about 1.0%( w/w) or less of the one or more emulsifying agents. In an embodiment, the buccal dosage form optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents. In an embodiment, the buccal dosage form comprises about 0.1 % (w/w) to about 1% (w/w) of the one or more emulsifying agents.
  • the buccal dosage form optionally further comprises one or more oils and/or fats.
  • the buccal dosage form further comprises about 10%(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the buccal dosage form comprises about 0.1 % (w/w) to about 1% (w/w), about 0.1 % (w/w) to about 2% (w/w), about 0.1 % (w/w) to about 3% (w/w), about 0.1 % (w/w) to about 4% (w/w) or about 0.1 % (w/w) to about 5% (w/w) of the one or more oils and/or fats.
  • the buccal dosage form further comprises from about 0.5% (w/w) to about 10% (w/w), from about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w) of the one or more oils and/or fats.
  • the buccal dosage form optionally further comprises about 1.0%(w/w) or less of one or more oils and/or fats. In an embodiment, the buccal dosage form further comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more oils and/or fats. In an embodiment, the buccal dosage form comprises about 0.1 % (w/w) to about 1% (w/w) of the one or more oils and/or fats
  • the buccal dosage form when the buccal dosage form is a soft chew lozenge, the buccal dosage form optionally further comprises one or more gelling agents. In an embodiment, the buccal dosage form further comprises about 25% or less, about 20% or less, about 15% (w/w) or less, about 10% (w/w) or less or about 5% (w/w) or less of the gelling agent.
  • the buccal dosage form further comprises of from about 1% (w/w) to about 25% (w/w), about 1% (w/w) to about 20% (w/w), about 1% (w/w) to about 15% (w/w), about 1 % (w/w) to about 10% (w/w), about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents.
  • the buccal dosage form optionally further comprises one or more flavourants.
  • the buccal dosage form comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the buccal dosage form comprises about 1.0%(w/w) or less of the one or more flavourants. In an embodiment, the buccal dosage form comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more flavourants.
  • the buccal dosage form comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants.
  • the buccal dosage form optionally further comprises one or more pH modifying agents.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3%(w/w) or less, or about 4%(w/w) or less of the one or more pH modifying agents.
  • the buccal dosage form comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 2% (w/w) of the one or more pH modifying agents.
  • the buccal dosage form comprises about 1.0%(w/w) or less of the pH modifying agent. In an embodiment, the buccal dosage form further comprises about 0.1% (w/w), about 0.2%(w/w), or about 0.3% (w/w) of the pH modifying agent. [00142] In an embodiment, when the buccal dosage form, for example, is a compressed tablet lozenge, the buccal dosage form optionally further comprises one or more lubricants.
  • the buccal dosage form comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more lubricants.
  • the buccal dosage form comprises about 0.1% (w/w) to about 5% (w/w), about 0.1% (w/w) to about 4% (w/w), about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of the one or more lubricants.
  • the emulsifying agent is otherwise known as a surfactant or emulsifier.
  • the emulsifying agent or surfactants for use in the buccal dosage forms of the present invention comprise surfactants commonly used in the formulation of pharmaceuticals.
  • the one or more emulsifying agents are selected from ionic- and non-ionic surfactants and wetting agents.
  • the one or more emulsifying agents are selected from monoglycerides of fatty ester, diglycerides of fatty esters, sucrose esters of fatty acids, polyglycerol esters of fatty acids, acetylated tartaric acid esters of monoglycerides, acetylated tartaric acid esters of diglycerides, citric acid esters of monoglycerides, citric acid esters of diglycerides, lactylated monoglycerides, lactylated diglycerides, lactylic esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of interesterified castor oil fatty acids, polyoxyethylene fatty esters, propylene glycol alginates, propylene glycol ether of methylcellulose, propylene glycol mono fatty acid esters, quillaia extract, sodium stearoyl-2- lactylate, sodium stearate, stearyl monoglycerides,
  • Cremophor® polyglycolyzed glycerides, acetylated monoglycerides, sorbitan fatty acid esters, poloxamers, polyoxyethylene sorbitan fatty acid esters (e.g Tween® series), polyoxyethylene derivatives (e.g., Brij® series), monoglycerides or ethoxylated derivatives thereof, diglycerides or polyoxyethylene derivatives thereof, sodium docusate, sodium laurylsulfate, cholic acid or derivatives thereof, lecithin, hydroxylated lecithin, hydrolyzed lecithin, gum Arabic, modified gum Arabic, phospholipids, hydrocolloids and combinations thereof.
  • Cremophor® polyglycolyzed glycerides, acetylated monoglycerides, sorbitan fatty acid esters, poloxamers, polyoxyethylene sorbitan fatty acid esters (e.g Tween® series), polyoxyethylene derivatives (e
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy lecithin.
  • the one or more oils are selected from long chain triglycerides (LOT) and medium chain triglycerides (MCTs). In an embodiment, the one or more oils are medium chain triglycerides (MCTs). In an embodiment, the one or more oils are vegetable oils. In an embodiment, the one or more vegetable oils are selected from soybean oil, sunflower oil, olive oil, palm oil, coconut oil, canola oil, peanut oil, cottonseed oil, corn oil, safflower oil, sesame oil, grape seed oil, hemp seed oil, and flaxseed oil, and combinations thereof. In an embodiment, the oils are selected from sunflower oil or coconut oil. In an embodiment, the oil is coconut oil. In an embodiment, the coconut oil is fractionated coconut oil.
  • the one or more fats are animal fats or animal derived fats.
  • the animal or animal derived fats are selected from butter, ghee, and milk fat.
  • the one or more gelling agents are selected from gelatin, pectin, agar, carrageenan, alginate, gellan gum, xanthan gum, cellulose gum, and modified starch and combinations thereof. In an embodiment, the one or more gelling agents are selected from gelatin, agar, carrageenan, alginate, gellan gum, xanthan gum, cellulose gum, and modified starch and combinations thereof. In an embodiment, the gelling agent is gelatin.
  • the one or more pH modifying agents are food grade acids or salts thereof.
  • the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof.
  • the pH modifying agent is citric acid.
  • the pH modifying agent is sodium bicarbonate or potassium bitartrate.
  • the one or more flavourants is an unsweetened flavourant.
  • the one or more flavourants are selected from synthetic flavor oils, flavoring aromatics, natural oils, extracts from plants, leaves, flowers, fruits and combinations thereof.
  • the one or more flavourants are selected from cinnamon oil, oil of Wintergreen, peppermint oils, clove oil, bay oil, anise oil, eucalyptus, thyme oil, cedar leave oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, vanilla, citrus oil, fruit essences and menthol.
  • the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the one or lubricants are selected from calcium stearate, hydrogenated castor oil, hydrogenated coconut oil, glyceryl tristearate, lauric acid NF32, magnesium stearate, light mineral oil, myristic acid, hydrogenated palm oil, palmitic acid, polyethylene glycol, potassium benzoate, sodium benzoate, sodium lauryl sulfate, sodium stearate, sodium stearyl fumarate, stearic acid, stearic acid, talc, hydrogenated vegetable oil type I and zinc stearate.
  • the lubricant is magnesium stearate.
  • a buccal dosage form comprising:
  • the present application includes a buccal dosage form comprising:
  • (c) optionally about 1% (w/w) to about 2% (w/w) or less of one or more emulsifying agents.
  • the present application also includes a buccal dosage form comprising:
  • the present application also includes a buccal dosage form comprising:
  • oils and/or fats optionally 0.1% (w/w) to about 5% (w/w) of one or more oils and/or fats.
  • the buccal dosage form is free of added sugars, sweeteners and/or sweetening agents as described above.
  • the one or more oligosaccharides having a DP of about 10 or less are as described above.
  • the one or more polysaccharides are as described above.
  • the one or more emulsifying agents are as described above.
  • the one or more oils and/or fats are as described above.
  • the buccal dosage form optionally further comprises one or more plasticizers, flavourants, gelling agents, pH modifying agents and lubricants as described above.
  • the buccal dosage form optionally further comprises one or more flavourants.
  • the buccal dosage form may also comprise further excipients used in the formation of buccal dosage forms such as carriers (e.g., lactose or corn starch) and binding agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate); disintegrants (e.g., potato starch, sodium starch glycolate, croscarmellose sodium, and crospovidone); or wetting agents (e.g., sodium lauryl sulphate).
  • carriers e.g., lactose or corn starch
  • binding agents e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose
  • fillers e.g., lactose, microcrystalline cellulose or calcium phosphate
  • disintegrants e.g., potato starch, sodium starch glycolate, cro
  • the buccal dosage form optionally further comprises a coating.
  • the coating comprises carnauba wax, beeswax, gelatin, acetylated monoglyceride, starch, zein, shellac, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations thereof.
  • the coating provides a glossy or semi-glossy appearance, a smooth surface, and/or a pleasant visual aesthetic. In some cases, the coating provides a hard outer coating.
  • the buccal forms of the application do not comprise a coating.
  • the Applicant has prepared lozenges comprising one or more cannabinoids and/or cannabinoid extract and one or more oligosaccharides having a degree of polymerization of about 10 or less. Therefore, in an embodiment, the buccal dosage form is a lozenge.
  • the lozenge is a hard molded lozenge, a soft chew lozenge, a compressed tablet lozenge, a soft lozenge, a troche, a cachou, a pill, a capsule, a tab, a pellet, a dragee or a pastille.
  • the lozenge is a compressed tablet or troche.
  • the lozenge is adapted for administration sublingually.
  • the lozenge is adapted for administration as a lollipop.
  • the lozenge can be swallowed.
  • the lozenge is a hard molded lozenge, soft chew lozenge, or a compressed tablet lozenge.
  • the lozenge is a hard molded lozenge, or a compressed tablet lozenge.
  • the Applicant has prepared hard molded lozenges comprising the one or more oligosaccharides such as fructo-oligosaccharides alone or in combination with one or more polysaccharides such as inulin, and optionally including a plasticizer such as glycerin.
  • the Applicant has also prepared one or more polysaccharides such as inulin and a plasticizer such glycerin.
  • the buccal dosage forms have been prepared without any added sugars, sweeteners, or sweetening agents.
  • the present application also includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 10% (w/w) to about 99.9% (w/w), about 15% (w/w) to about 99.9% (w/w), about 20% (w/w) to about 99.9% (w/w), about 25% (w/w) to about 99.9% (w/w), about 30% (w/w) to about 99.9% (w/w), about 35% (w/w) to about 99.9% (w/w), about 40% (w/w) to about 99.9% (w/w), about 45% (w/w) to about 99.9% (w/w), about 50% (w/w) to about 99.9% (w/w), about 55% (w/w) to about 99.9% (w/w), about 60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to about 99.9% (
  • the hard molded lozenge comprises about 10% (w/w) to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about 95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 40% (w/w) to about 60% (w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w) to about 10% (
  • the hard molded lozenge comprises about 85% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about 96% (w/w) to about 99.9% (w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w), about 99.9% (w/w) to about 99.9% (w/w), about 99.8% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99% (w/w), about 96% (w/w) to about 99% (w/w), about 97% (w/w) to about 99% (w/w), about 98% (w/w) to about 99% (
  • the hard molded lozenge comprises about 96% (w/w) to about 99% (w/w) of one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises about 96% (w/w) to about 98.5% (w/w) of one or more oligosaccharides.
  • the present application includes a hard molded lozenge comprising:
  • the hard molded lozenge is comprised primarily of the one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises more than about 70% of the one or more oligosaccharides having a degree of polymerization of about 10 or less
  • the present application also includes a hard molded lozenge comprising:
  • the present application includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 96% (w/w) to about 99.9% (w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w), about 99.7% (w/w) to about 99.9% (w/w) or about 99.8% (w/w) to about 99.9% (w/w) of the one or more oligosaccharides.
  • the hard molded lozenge comprises about 96% (w/w) to about 99% (w/w) of the one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises about 96% (w/w) to about 98.5% (w/w) of the one or more oligosaccharides.
  • the hard molded lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8.
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In some embodiments, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the hard molded lozenge comprises the one or more oligosaccharides having a degree of polymerization of about 10 or less as described above.
  • the one or more oligosaccharides are selected from digestible oligosaccharides and non- digestible oligosaccharides and combinations thereof as described above.
  • the one or more oligosaccharides are one or non-digestible oligosaccharide as described above.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the fructo-oligosaccharide is produced by the partial enzymatic hydrolysis of inulin from natural sources such as from chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana or agave, or the FOS is produced by the partial enzymatic hydrolysis from chicory inulin.
  • FOS is prepared by enzymatic synthesis with sucrose by methods known in the art, for example, by the transfructosylation of sucrose by p- fructofuranosidases.
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the one or more oligosaccharides is fructo-oligosaccharides.
  • the fructo-oligosaccharides has a degree of polymerization of about 10 or less, about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less.
  • the fructo-oligosaccharides has degree of polymerization of about 10 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 8 or less.
  • the fructo-oligosaccharides has a degree of polymerization of about 9 or less.
  • the fructo-oligosaccharides has a degree of polymerization of about 8 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about
  • the fructooligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about
  • the fructooligosaccharide has a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8. In an embodiment, the fructo-oligosaccharides has a degree of polymerization of about 3 to about 10. In an embodiment, the fructooligosaccharide has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5.
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 8.
  • fructo-oligosaccharide is considered to include inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide is fructo-oligosaccharide having a DP of 2).
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is an oligosaccharide having a DP of 2.
  • fructooligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a heterogenous mixture of oligosaccharides of different DPs of about 2 to about 10 or less including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) not including inulobiose.
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component described above is fructo-oligosaccharide having a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to about 9 or about 3 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is included as a component of the naturally occurring sugars in the fructo-oligosaccharide.
  • fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component is fructooligosaccharide having a DP of about 3 to about 10 or less which comprises a heterogenous mixture of oligosaccharides of different DPs of about 3 to about 10 or less not including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) including inulobiose.
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 8% (w/w), about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 % (w/w) to about 7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7% (w/w), about 0.1 % (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 % (w/w) to about 6% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5% (w/w), about 1 % (w/w) to about 1 % (w/
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 4% (w/w), about 1 % (w/w) to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to about 3% (w/w), of inulobiose on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the fructo-oligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 2 to about 10 or less comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructooligosaccharide.
  • the fructooligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 3 to about 10 or less comprises about 1 % (w/w) to about 8% (w/w) or 1% (w/w) to about 10% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the buccal dosage forms of the present application are free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the hard molded lozenges of the application may comprise residual water resulting from the manufacturing process.
  • the buccal dosage form comprises about 5% (w/w) or less, about 4% (w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the buccal dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the present application includes a hard molded lozenge comprising the one or more cannabinoids, and/or a cannabinoid extract as described above. In an embodiment, the present application also includes a hard molded lozenge comprising the one or more cannabinoids as described above. In an embodiment, the present application includes a hard molded lozenge comprising the one or more cannabinoid extracts as described above. In an embodiment, the one or more cannabinoid extracts is a cannabinoid distillate. In an embodiment, the one or more cannabinoids is selected from THC and CBD and combinations thereof and combinations thereof. In an embodiment, the one or more cannabinoids is THC.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1 :400, about 1 :1000 to about 1:500, about 1 :1000 to about 1 :600, or about 1: 1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the hard molded lozenge comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the hard molded lozenge comprises THC and CBD
  • the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the hard molded lozenge comprises 10mg of THC and 2mg of CBD.
  • the hard molded lozenge comprises equal amounts of THC and CBD. In an embodiment, the hard molded lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the hard molded lozenge comprises 2.5mg of THC and 2.5mg of CBD.
  • the cannabinoid extract is purified such that one or more cannabinoid is present at greater than about 80% (w/w), greater than about 85% or greater than about 95% of the total extract (w/w).
  • the hard molded lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or 0.1 mg to about 1 mg of THC.
  • the cannabinoid extract comprises THC of about 0.1 mg to about 10 mg.
  • the hard molded lozenge comprises 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg of THC.
  • the Applicant has prepared a hard molded lozenge comprising about 1% (w/w) of a cannabinoid extract that comprises about 10mg of THC. Accordingly, the Applicant has prepared a high potency hard molded lozenge. Therefore, in an embodiment, the hard molded lozenge is a high potency hard molded lozenge. Accordingly, in an embodiment, the present application includes a high potency hard molded lozenge.
  • the hard molded lozenge optionally further comprises one or more polysaccharides.
  • the one or more polysaccharides have a degree of polymerization of up to about 80 and have an average degree of polymerization of about 9 or greater.
  • the added % (w/w) of the one or more polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides in the hard molded lozenge.
  • the present application also includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 10% (w/w) to about 99.8% (w/w), about 15% (w/w) to about 99.8% (w/w), about 20% (w/w) to about 99.8.9% (w/w), about 25% (w/w) to about 99.8% (w/w), about 30% (w/w) to about 99.8% (w/w), about 35% (w/w) to about 99.8% (w/w), about 40% (w/w) to about 99.8% (w/w), about 45% (w/w) to about 99.8% (w/w), about 50% (w/w) to about 99.8% (w/w), about 55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8% (w/w), about 65% (w/w) to about 99.8% (w/w), about 70% (w/w) to about 99.8% (w/w),
  • the buccal dosage form comprises about 50% (w/w) to about 99.8% (w/w), about 55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8% (w/w), about 65% (w/w) to about 99.8% (w/w), about 70% (w/w) to about 99.8% (w/w), about 75% (w/w) to about 99.8% (w/w), about 80% (w/w) to about 99.8% (w/w), about 85% (w/w) to about 99.8% (w/w), about 90% (w/w) to about 99.8% (w/w), about 95% (w/w) to about 99.8% (w/w), about 96% (w/w) to about 99.8% (w/w), about 97% (w/w) to about 99.8% (w/w), about 98% (w/w) to about 99.8% (w/w), about 99% (w/w) to about 99.8% (w/w),
  • the hard molded lozenge comprises about 10% (w/w) to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about 95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about 95%
  • the buccal dosage form comprises about 50% (w/w) to about 99.8% (w/w), about 55% (w/w) to about 99.8% (w/w), about 60% (w/w) to about 99.8% (w/w). In an embodiment, the buccal dosage form comprises about 85% (w/w) to about 99.8% (w/w), about 90% (w/w) to about 99.8% (w/w), about 95% (w/w) to about 99.8% (w/w), about 96% (w/w) to about 99.8% (w/w), about 97% (w/w) to about 99.8% (w/w), about 98% (w/w) to about 99.8% (w/w), about 99% (w/w) to about 99.8% (w/w), about 99.5% (w/w) to about 99.8% (w/w), about 99.8% (w/w) to about 99.8% (w/w) or about 99.8% (w/w) to about 99.8% (w/w)
  • the hard molded lozenge comprises about 0.1% (w/w) to about 89.9% (w/w), about 0.5% (w/w) to about 89.9% (w/w), about 1% (w/w) to about 89.9% (w/w), about 5% (w/w) to about 89.9% (w/w), about 10% (w/w) to about 89.9%(w/w), about 15% (w/w) to about 89.9% (w/w), about 20% (w/w) to about 89.9% (w/w), about 25% (w/w) to about 89.9%(w/w), about 30% (w/w) to about 89.9% (w/w), about 35% (w/w) to about 89.9% (w/w), about 40% (w/w) to about 89.9%(w/w), about 45% (w/w) to about 89.9% (w/w), about 50% (w/w) to about 89.9% (w/w/w/w), about
  • the buccal dosage form comprises about 0.1% (w/w) to about 88.9% (w/w), about 0.1% (w/w) to about 80% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 50% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70% (w/w), about 5% (w/w) to about 50% (w/w), about 10% (w/w) to about 70%(w/w), about 15% (w/w) to about 60% (w/w), about 20% (w/w) to about 75% (w/w), about 25% (w/w) to about 75%(w/w), 0.1% (w/w) to about 74% (w/w), about 40% (w/w) to about 70% (w/w), about 10% (w/w) to about 30%(w/w), about 15% (w/w) to about 25% (w/w), about 50% (w/w/w),
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 99.9 % (w/w) of the buccal dosage form.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 99.9% (w/w), about 65% (w/w) to about 99.9% (w/w), about 70% (w/w) to about 99.9% (w/w), about 75% (w/w) to about 99.9% (w/w), about 80% (w/w) to about 99.9% (w/w), about 85% (w/w) to about 99.9% (w/w), about 90% (w/w) to about 99.9% (w/w), about 95% (w/w) to about 99.9% (w/w), about 97% (w/w) to about 99.9% (w/w), about 98% (w/w/w/w), about 60% (w/w) to
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the one or more polysaccharides are selected from the polysaccharides described above.
  • the one or more polysaccharides is inulin.
  • the buccal dosage form comprises about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree of polymerization of upto 60 and having an average degree of polymerization of about 9 or greater.
  • the buccal dosage comprises about 0.1% (w/w) to about 89.9% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater, wherein the one or more oligosaccharides and the inulin combined comprise about 95% (w/w) to about 99.9% (w/w) of the buccal dosage form.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater. In an embodiment, the inulin is Orafti® inulin by Beneo Inc. (New Jersey, U.S.A).
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1:400, about 1 :1000 to about 1 :500, about 1 :1000 to about 1:600, or about 1 :1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the hard molded lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, flavourants, and pH modifying agents as described above.
  • the hard molded lozenge optionally further comprises one or more emulsifying agents.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, about 5%(w/w) or less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less, about 9% (w/w) or less, or about 10% (w/w) or less of an emulsifying agent.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
  • the hard molded lozenge comprises about 0.5% (w/w) or less, about 1% (w/w) or less, about 2%(w/w), about 3% (w/w) or less, about 4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
  • the hard molded lozenge comprises about 0.5% (w/w) or less, about 1% (w/w) or less or about 2%(w/w) or less of the one or more emulsifying agents. In an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to about 0.5% (w/w), about 0.1% (w/w) to about 1% (w/w), about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or about 0.1% (w/w) to about 4% (w/w) of the one or more emulsifying agents.
  • the hard molded lozenge further comprises from about 0.5% (w/w) to about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w), about 0.5% (w/w) to about 3%(w/w), about 0.5% (w/w) to about 2%(w/w), about 0.5% (w/w) to about 1 %(w/w) of the one or more emulsifying agents.
  • the hard molded lozenge comprises from about 0.5% (w/w) to about 5%(w/w), or from about 0.5% (w/w) to about 4%(w/w)
  • the hard molded lozenge optionally comprises about 2.0%( w/w) or less of the one or more emulsifying agents. In an embodiment, the hard molded lozenge optionally comprises about 1.0% (w/w) or less of the one or more emulsifying agents. In an embodiment, the buccal dosage form optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents. In an embodiment, the hard molded lozenge comprises about 0.1% (w/w) to about 1% (w/w) of the one or more emulsifying agents.
  • the hard molded lozenge optionally further comprises one or more oils and/or fats.
  • the hard molded lozenge further comprises about 10%(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less, about 0.5% (w/w) or less of the one or more oils and/or fats.
  • the hard molded lozenge further comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1%(w/w) or less, about 0.5% (w/w) or less of the one or more oils and/or fats.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 0.5% (w/w), 0.1% (w/w) to about 1% (w/w), about 0.5% (w/w) to about 1% (w/w), about 0.5% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 4% (w/w) or about 0.1% (w/w) to about 5% (w/w) of the one or more oils and/or fats.
  • the hard molded lozenge further comprises from about 0.5% (w/w) to about 10% (w/w), about 0.5% (w/w) to about 9%(w/w), about 0.5% (w/w) to about 8%(w/w), about 0.5% (w/w) to about 7%(w/w), about 0.5% (w/w) to about 6%(w/w), about 0.5% (w/w) to about 5%(w/w), about 0.5% (w/w) to about 4%(w/w), about 0.5% (w/w) to about 3%(w/w), about 0.5% (w/w) to about 3%(w/w), about 0.5% (w/w) to about 2% (w/w) or about 0.5% (w/w) to about 1%(w/w) of the one or more oils and/or fats.
  • the hard molded lozenge optionally further comprises about 2%(w/w) or less of one or more oils and/or fats. In an embodiment, the hard molded lozenge optionally further comprises about 1%(w/w) or less of one or more oils and/or fats. In an embodiment, the buccal dosage form further comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more oils and/or fats.
  • the hard molded lozenge comprises about 0.5 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more oils and/or fats.
  • the hard molded lozenge optionally further comprises one or more flavourants.
  • the hard molded lozenge comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the hard molded lozenge comprises about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 1% (w/w), or about 0.1% (w/w) to about 0.5% (w/w) of the one or more flavourants.
  • the hard molded lozenge comprises about 2%(w/w) or less of the one or more flavourants. In an embodiment, the hard molded lozenge comprises about 1%(w/w) or less of the one or more flavourants. In an embodiment, the hard molded lozenge comprises about 0.1% (w/w), about 0.2%(w/w), about 0.3% (w/w), about 0.4% (w/w), about 0.5% (w/w), about 0.6% (w/w), or about 0.7% (w/w) of the one or more flavourants.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 0.5% (w/w), about 0.1% (w/w) to about 1.5% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants.
  • the hard molded lozenge optionally further comprises one or more pH modifying agents.
  • the hard molded lozenge comprises about 1.0%(w/w) or less of the pH modifying agent.
  • the hard molded lozenge further comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, or about 0.3% (w/w) or less of the pH modifying agent.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 0.5% (w/w), about 0.5 % (w/w) to about 1% (w/w), about 0.1% (w/w) to about 1% (w/w) of the one or more flavourants.
  • the hard molded lozenge is comprised primarily of the one or more oligosaccharides. Accordingly, in an embodiment, the present application includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 96% (w/w) to about 99.9% (w/w) of one or more oligosaccharides, about 97% (w/w) to about 99.9% (w/w), about 98% (w/w) to about 99.9% (w/w), about 99% (w/w) to about 99.9% (w/w), about 99.5% (w/w) to about 99.9% (w/w), about 99.7% (w/w) to about 99.9% (w/w) or about 99.8% (w/w) to about 99.9% (w/w) of one or more oligosaccharides.
  • the hard molded lozenge comprises about 96% (w/w) to about 99% (w/w) of one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises about 96% (w/w) to about 98.5% (w/w) of one or more oligosaccharides.
  • the present application also includes a hard molded lozenge comprising:
  • the present application also includes a hard molded lozenge m comprising: (a) one or more cannabinoids, and/or a cannabinoid extract;
  • (d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying agents.
  • the present application also includes a buccal dosage form comprising:
  • (d) optionally about 0.1% (w/w) to about 5% (w/w) of one or more emulsifying agents.
  • the hard molded lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the one or more emulsifying agents are as described above.
  • the one or more oils and/or fats are as described above.
  • the hard molded lozenge optionally further comprises one or more plasticizers, flavourants, gelling agents, pH modifying agents and lubricants as described above.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents as described above. In an embodiment, the hard molded lozenge further comprises about 1%( w/w) or less of the one or more emulsifying agents as described above.
  • the hard molded lozenge further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.1 % (w/w) to about 1 % (w/w) about 0.1 % (w/w) to about 0.5 % (w/w) or about 0.5 % (w/w) to about 1% (w/w) of one or more emulsifying agents as described above.
  • the hard molded lozenge optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents. In an embodiment, the hard molded lozenge optionally comprises about 0.5% (w/w) or less of the one or more emulsifying agents
  • the one or more emulsifying agents are as described above.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the hard molded lozenge comprises about 1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the buccal dosage form comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.1 % (w/w) to about 1% (w/w), about 0.5 % (w/w) to about 1% (w/w) or about 0.1 % (w/w) to about 2% (w/w one or more oils and/or fats. In an embodiment, the one or more oils and/or fats are as described above. In an embodiment, the one or more oils are vegetable oils. In an embodiment, the hard molded lozenge does not comprise a fat.
  • the hard molded lozenge optionally comprises about 1% (w/w) or less of the one or more pH modifying agents. In an embodiment, the hard molded lozenge optionally comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about 1% (w/w) or about 0.1% (w/w) to about 1% (w/w) of the one or more pH modifying agents. In an embodiment, the one or more pH modifying agents are as described above. In an embodiment, the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof, thereof. In an embodiment, the pH modifying agent is citric acid.
  • the hard molded lozenge optionally comprises about 1% (w/w) or less of the one or more flavourants. In an embodiment, the hard molded lozenge optionally comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about 1% (w/w) or about 0.1% (w/w) to about 1% (w/w) of the one or more flavourants. In an embodiment, the one or more flavourants are as described above. In an embodiment, the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises the composition as described in Example 1.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 2% (w/w) of a cannabinoid extract; about 95% (w/w) to about 99% of one or more oligosaccharides; optionally about 0.1 (w/w) to about 1%(w/w) of an emulsifying agent; optionally about 0.1 to about 1% of a fat/oil; and optionally about 0.1% (w/w) to about 1% (w/w) of a flavourant.
  • the cannabinoid extract comprises about 0.1 mg to about 10mg of THC.
  • the hard molded lozenge comprises about the hard molded lozenge comprises about of the one or more oligosaccharides selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the hard molded lozenge comprises about 0.1 to about 1% of the one or more emulsifying agents selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 1% (w/w) of the one or more oils and/or fats and the one or more oils and/or fats are as described above.
  • the one or more oils are vegetable oils.
  • the one or more oils is fractionated coconut oil.
  • the more oils and/or fats comprises about 0.1 % (w/w) to about 1% (w/w) of the one or more flavourants selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 1% (w/w) of a cannabinoid extract (e.g.
  • cannabis distillate about 95% (w/w) to about 99% of FOS having a degree of polymerization of about 2 to about 8; optionally about 0.1% (w/w) to about 1% (w/w) of soy lecithin; optionally about 0.1 % (w/w) to about 1% (w/w) of fractionated coconut oil; and optionally about 0.1%(w/w) to about 1% (w/w) of peppermint oil.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 99.9% (w/w) of one or more oligosaccharides having a degree of polymerization of about 2 to about 9 selected from fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylooligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof; about 0.1 (w/w) to about 0.2% (w/w) of an emulsifying agent; optionally about 0.1% (w/w) to about 2% (w/w) of one or more oils and/or fats; and optionally about 0.1 % (w/w) to about 1% (w/
  • a plasticizer such as glycerin provides a favourable and controllable rate of dissolution and also decreases the temperature of solidification and increases moldability of the bulk lozenge product in the preparation of the hard molded lozenge dosage forms. Decreasing temperature of the solidification advantageously decreases the amount of hydrolysis of the one or more oligosaccharides by eliminating exposure to thermal abuse.
  • the hard molded lozenge optionally further comprises one or more plasticizers.
  • the present application also includes a hard molded lozenge comprising:
  • the one or more oligosaccharides having a degree of polymerization of about 10 or less are as described above.
  • the buccal dosage form is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the lozenge comprises about 2% (w/w) to about 15% (w/w), about 2 % (w/w) to about 12% (w/w), about 2% (w/w) to about 10% (w/w), about 2% (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the plasticizer.
  • the lozenge comprises about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizer. In an embodiment, the lozenge comprises about 5% (w/w) of the plasticizer.
  • the one or more plasticizers is selected from glycerin and polyethylene glycol and combinations thereof. In an embodiment, the one or more plasticizers is glycerin.
  • the hard molded lozenge comprises about 10% (w/w) to about 97.9% (w/w), about 15% (w/w)to about 97.9% (w/w), about 20% (w/w) to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w), about 30% (w/w) to about 97.9% (w/w), about 35% (w/w) to about 97.9% (w/w), about 40% (w/w) to about 97.9% (w/w), about 45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about 97.9% (w/w), about 55% (w/w) to about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w), about 65% (w/w) to about 97.9% (w/w), about 70% (w/w) to about 97.9% (w/w),
  • the hard molded lozenge comprises about 10% (w/w) to about 95% (w/w), about 15% (w/w) to about 95% (w/w), about 20% (w/w) to about 95% (w/w), about 25% (w/w) to about 95% (w/w), about 25% (w/w) to about 90% (w/w), about 25% (w/w) to about 85% (w/w), about 25% (w/w) to about 80% (w/w), about 25% (w/w) to about 75% (w/w), about 25% (w/w) to about 60% (w/w), about 25% (w/w) to about 50% (w/w), about 30% (w/w) to about 50% (w/w), about 40% (w/w) to about 50% (w/w), about 45% (w/w) to about 50% (w/w), about 45% (w/w) to about 55% (w/w), about 20% (w/w) to about 60% (w/w), about 20% (w/w) to about 95%
  • the hard molded lozenge comprises about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), or about 96% (w/w) to about 97.9% (w/w).
  • the hard molded lozenge when a plasticer is present, comprises about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w), about 92% (w/w) to about 97.9% (w/w), or about 94% (w/w) to about 96% (w/w) of one or more oligosaccharides. In an embodiment, when a plasticer is present, the hard molded lozenge comprises about 92% (w/w) to about 96% (w/w) of one or more oligosaccharides.
  • the present application includes a hard molded lozenge comprising:
  • the hard molded lozenge is comprised primarily of the one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises more than about 70% of the one or more oligosaccharides having a degree of polymerization of about 10 or less.
  • the present application also includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 75% (w/w) to about 97.9% (w/w), about 80% (w/w) to about 97.9% (w/w), about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w), about 92% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w), about 97% (w/w) to about 97.9% (w/w), about 80% (w/w) to about 96% (w/w), about 80% (w/w) to about 95% (w/w), about 85% (w/w) to about 95% (w/w), about 85% (w/w) to about 90% (w/w), about 85% (w/w) to about 97% (w/w), about 90% (w/w), about 85% (
  • the hard molded lozenge comprises 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w) or about 95% (w/w) to about 97.9% of one or more oligosaccharides. In an embodiment, the hard molded lozenge comprises about 90% (w/w) to about 97.9% (w/w) or about 95% (w/w) to about 97.9% (w/w) of one or more oligosaccharides.
  • the hard molded lozenge comprises the one or more oligosaccharides having a degree of polymerization of about 10 or less as described above.
  • the one or more oligosaccharides are selected from digestible oligosaccharides and non- digestible oligosaccharides and combinations thereof as described above.
  • the one or more oligosaccharides are one or non-digestible oligosaccharide as described above.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the fructo-oligosaccharide (FOS) is produced by the partial enzymatic hydrolysis of inulin from natural sources such as from chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana or agave.
  • the FOS is produced by the partial enzymatic hydrolysis from chicory inulin.
  • FOS is prepared by enzymatic synthesis with sucrose by methods known in the art, for example, by the transfructosylation of sucrose by p-fructofuranosidases.
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less. In an embodiment, the one or more oligosaccharides have degree of polymerization of about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5.
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8. [00240] In an embodiment, the one or more oligosaccharides is fructo-oligosaccharides.
  • the fructo-oligosaccharides has a degree of polymerization of about 10 or less, about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less. In an embodiment, the fructo-oligosaccharides has degree of polymerization of about 10 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the fructo-oligosaccharides has a degree of polymerization of about 9 or less. In an embodiment, the fructo-oligosaccharides has a degree of polymerization of about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10. In an embodiment, the fructo-oligosaccharides has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the fructooligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about
  • the fructooligosaccharides has a degree of polymerization of about 2 to about 9, about 3 to about 9, about
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 8.
  • fructo-oligosaccharide is considered to include inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide is fructo-oligosaccharide having a DP of 2).
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is an oligosaccharide having a DP of 2.
  • fructooligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a heterogenous mixture of oligosaccharides of different DPs of about 2 to about 10 or less including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) not including inulobiose.
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component described above is fructo-oligosaccharide having a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to about 9 or about 3 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is included as a component of the naturally occurring sugars in the fructo-oligosaccharide.
  • fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component is fructooligosaccharide having a DP of about 3 to about 10 or less which comprises a heterogenous mixture of oligosaccharides of different DPs of about 3 to about 10 or less not including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) including inulobiose.
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 8% (w/w), about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 % (w/w) to about 7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7% (w/w), about 0.1 % (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 % (w/w) to about 6% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5% (w/w), about 1 % (w/w) to about 1 % (w/
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 1 % (w/w) to about 4%(w/w), about 1 % (w/w) to about 3 (w/w), about 1.5 % (w/w) to about 3%(w/w), about 2 % (w/w) to about 3% (w/w), of inulobiose on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the fructo-oligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 2 to about 10 or less comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructooligosaccharide.
  • the fructooligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 3 to about 10 or less comprises about 1% (w/w) to about 8% (w/w) or 1% (w/w) to about 10% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the hard molded lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the hard molded lozenges of the application may comprise residual water resulting from the manufacturing process.
  • the buccal dosage form comprises than about 5% (w/w) or less, about 4% (w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the buccal dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the hard molded lozenge comprises about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total weight of the hard molded lozenge basis.
  • the hard molded lozenge comprises about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total weight of the hard molded lozenge basis.
  • the monosaccharides and disaccharides are present as a natural component of the one or more oligosaccharides and/or formed as a by-product of the manufacturing process.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1 :5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1 :400, about 1 :1000 to about 1:500, about 1 :1000 to about 1 :600, or about 1: 1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is or comprises THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is or comprises CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the hard molded lozenge comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the hard molded lozenge comprises THC and CBD
  • the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the hard molded lozenge comprises 10mg of THC and 2mg of CBD.
  • the hard molded lozenge comprises equal amounts of THC and CBD. In an embodiment, the hard molded lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the hard molded lozenge comprises 2.5mg of THC and 2.5mg of CBD.
  • the cannabinoid extract is purified such that one or more cannabinoid is present at greater than about 80% (w/w), greater than about 85% or greater than about 95% of the total extract (w/w).
  • the hard molded lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or 0.1 mg to about 1 mg of THC.
  • the cannabinoid extract comprises THC of about 0.1 mg to about 10 mg.
  • the hard molded lozenge comprises 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of a cannabinoid extract and the cannabinoid extract comprises about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg of THC.
  • the Applicant has prepared a hard molded lozenge comprising a plasticizer and comprising about 1% (w/w) of a cannabinoid extract that comprises about 10mg of THC
  • the Applicant has prepared a high potency hard molded lozenge. Therefore, in an embodiment, the hard molded lozenge is a high potency hard molded lozenge. Accordingly, in an embodiment, the present application includes a high potency hard molded lozenge.
  • the hard molded lozenge optionally further comprises one or more polysaccharides.
  • the one or more polysaccharides have a degree of polymerization of up to about 80 and have an average degree of polymerization of about 9 or greater.
  • the added % (w/w) of the one or more polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides in the buccal dosage form.
  • the present application also includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 10% (w/w) to about 97.8% (w/w), about 15% (w/w) to about 97.8% (w/w), about 20% (w/w) to about 97.8% (w/w), about 25% (w/w) to about 97.8% (w/w), about 30% (w/w) to about 97.8% (w/w), about 35% (w/w) to about 97.8% (w/w), about 40% (w/w) to about 97.8% (w/w), about 45% (w/w) to about 97.8% (w/w), about 50% (w/w) to about 97.8% (w/w), about 55% (w/w) to about 97.8% (w/w), about 60% (w/w) to about 97.8% (w/w), about 65% (w/w) to about 97.8% (w/w), about 70% (w/w/w/w), about 10% (w/w) to about 97.8% (w
  • the hard molded lozenge comprises about 85% (w/w) to about 97.8% (w/w), about 90% (w/w) to about 97.8% (w/w), about 95% (w/w) to about 97.8% (w/w), or about 96% (w/w) to about 97.8% (w/w) of one or more oligosaccharides.
  • the hard molded lozenge comprises about 85% (w/w) to about 97.8% (w/w), about 90% (w/w) to about 97.8% (w/w), about 92% (w/w) to about 97.8% (w/w), or about 94% (w/w) to about 96% (w/w) of one or more oligosaccharides.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 87.9% (w/w), about 0.5% (w/w) to about 87.9% (w/w), about 1% (w/w) to about 87.9% (w/w), about 5% (w/w) to about 87.9% (w/w), about 10% (w/w) to about 87.9%(w/w), about 15% (w/w) to about 87.9% (w/w), about 20% (w/w) to about 87.9% (w/w), about 25% (w/w) to about 87.9%(w/w), about 30% (w/w) to about 87.9% (w/w), about 35% (w/w) to about 87.9% (w/w), about 40% (w/w) to about 87.9%(w/w), about 45% (w/w) to about 87.9% (w/w), about 50% (w/w)
  • the hard molded lozenge comprises about 0.1% (w/w) to about 87.9% (w/w), about 0.1% (w/w) to about 80% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 50% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70% (w/w), about 5% (w/w) to about 50% (w/w), about 10% (w/w) to about 70%(w/w), about 15% (w/w) to about 60% (w/w), about 20% (w/w) to about 74% (w/w), about 25% (w/w) to about 75%(w/w), about 25% (w/w) to about 75% (w/w), 0.1% (w/w) to about 74% (w/w), about 40% (w/w) to about 70% (w/w), about 10% (w/w) to about 80% (w/w), about 0.1% (w
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 97.8 % (w/w) of the hard molded lozenge. In an embodiment, when a plasticer is present, the one or more oligosaccharides and the one or more polysaccharides comprise about 55% (w/w) to about 97.8% (w/w) of the hard molded lozenge.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 97.8 % (w/w), about 65% (w/w) to about 97.8 % (w/w), about 70% (w/w) to about 97.8 % (w/w), about 75% (w/w) to about 97.8 % (w/w), about 80% (w/w) to about 97.8 % (w/w), about 85% (w/w) to about 97.8 % (w/w), about 90% (w/w) to about 97.8 % (w/w), about 95% (w/w) to about 97.8 % (w/w), about 90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w), about 90% (w/w) to about 98%
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 97.8% (w/w), about 65% (w/w) to about 97.8% (w/w), about 70% (w/w) to about 97.8% (w/w), about 75% (w/w) to about 97.8% (w/w), about 80% (w/w) to about 97.8% (w/w), about 85% (w/w) to about 97.8% (w/w), ), about 90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w), about 90% (w/w) to about 95% (w/w), about 90% (w/w) to about 97.8% (w/w), about 95% (w/w) to about 97.8% (w/w), about 97% (w/w) to to
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the one or more polysaccharides are as described above.
  • the one or more polysaccharides is inulin.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 87.9% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 87.9% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater, wherein the one or more oligosaccharides and the inulin combined comprise about 55% (w/w) to about 97.9% (w/w) of the hard molded lozenge.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60.
  • the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater. In an embodiment, the inulin is Orafti® inulin by Beneo Inc. (New Jersey, U.S.A).
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1:400, about 1 :1000 to about 1 :500, about 1 :1000 to about 1 :600, or about 1 :1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides
  • the lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, plasticizers, flavourants, gelling agents, pH controlling agents, and lubricants as described above.
  • the present application includes a hard molded lozenge comprising:
  • (d) optionally about 0.1% (w/w) to about 3% (w/w) or less of one or more emulsifying agents.
  • the present application includes a lozenge comprising:
  • (d) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying agents.
  • the present application also includes a lozenge comprising:
  • the present application also includes a lozenge comprising:
  • (d) optionally about 0.1% (w/w) to about 3% (w/w) of one or more emulsifying agents.
  • the hard molded lozenge comprises the one or more oligosaccharides having a degree of polymerization of about 10 or less as described above. In an embodiment, the hard molded lozenge comprises one or more polysaccharides having a degree of polymerization up to about 80 and having an average degree of polymerization of about 9 or greater as described above.
  • the lozenge comprises about 2 % (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizers.
  • the lozenge comprises about 5% (w/w) of the one or more plasticizers.
  • the one or more plasticizers is glycerin.
  • the hard molded lozenge further comprises about 2% (w/w) or less or about 1 % (w/w) or less of one or more emulsifying agents as described above.
  • the hard molded lozenge further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1 % (w/w) to about 1 % (w/w), about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about 1 % (w/w) or about 0.5 % (w/w) to about 2 % (w/w) of one or more emulsifying agents as described above.
  • the hard molded lozenge further comprises about 0.5 % (w/w) or less, about 1%( w/w) or less of the one or more emulsifying agent as described above.
  • the hard molded lozenge optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents.
  • the hard molded lozenge optionally comprises about 0.5% (w/w) or less of the one or more emulsifying agents.
  • the one or more emulsifying agents are as described above.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the hard molded lozenge comprises about 1%( w/w) or less of the one or more oils and/or fats.
  • the hard molded lozenge further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.1 % (w/w) to about 1 % (w/w), about 0.5 % (w/w) to about 1 % (w/w), about 0.5 % (w/w) to about 2 % (w/w) or about 0.1 % (w/w) to about 0.5 % (w/w) of one or more oils and/or fats as described above.
  • the one or more oils and/or fats are as described above.
  • the one or more oils are vegetable oils.
  • the hard molded lozenge does not comprise a fat.
  • the hard molded lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the hard molded lozenge optionally comprises about 1%(w/w) or less of the one or more flavourants.
  • the hard molded lozenge optionally comprises about 0.1 % (w/w) to about 0.5 % (w/w), about 0.5 % (w/w) to about 1 % (w/w), about 0.5 % (w/w) to about 2 % (w/w) or about 0.1% (w/w) to about 1% (w/w) of the one or more flavourants.
  • the one or more flavourants are as described above.
  • the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises
  • flavourant optionally about 0.1 % (w/w) to about 1% (w/w) of a flavourant.
  • the hard molded lozenge comprises a cannabinoid extract. In an embodiment, the hard molded lozenge comprises about 0.1 mg to about 10mg of THC.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo- oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructo-oligosaccharides (FOS).
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the one or more oligosaccharides is fructo-oligosaccharides.
  • the fructo-oligosaccharides has a degree of polymerization of about 10 or less, about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less.
  • the fructo-oligosaccharides has degree of polymerization of about 10 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 9 or less.
  • the fructo-oligosaccharides has a degree of polymerization of about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10.
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8.
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 8.
  • the hard molded lozenge comprises the compositions as described in Example 13.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 96% of one or more oligosaccharides; about 3 % (w/w) to about 6% (w/w) of the one or more plasticizers; optionally about 0.1 % (w/w) to about 0.5% (w/w) of an emulsifying agent; and optionally about 0.1 % (w/w) to about 1% (w/w) of a flavourant.
  • the cannabinoid extract comprises about 0.1mg to about 10mg of THC. In an embodiment, the cannabinoid extract comprises about 10mg of THC. In an embodiment, the hard molded lozenge comprises about 90% (w/w) to about 96% (w/w) of one or more oligosaccharides selected from fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylooligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • FOS fructo-oligosaccharides
  • GOS galactooligosaccharides
  • IMO isolmalto-oligosaccharides
  • raffinose family of oligosaccharides and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructo-oligosaccharides (FOS).
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the hard molded lozenge comprises about 0.1 to about 0.5 of the one or more emulsifying agents selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the one or more emulsifying agents is lecithin.
  • the hard molded lozenge comprises about 0.1 %( (w/w) to about 1%(w/w) of the one or more flavourants selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract (e.g.
  • cannabis distillate about 90% (w/w) to about 96% of FOS having a degree of polymerization of about 2 to about 8; about 3% (w/w) to about 6% of glycerin; optionally about 0.1 % (w/w) to about 0.5% (w/w) of lecithin, and optionally about 0.1 % (w/w) to about 1% (w/w) of peppermint oil.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 96% (w/w) of one or more oligosaccharides having a degree of polymerization of about 2 to about 9 selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof; about 3 % (w/w) to about 6% (w/w) of glycerin; optionally about 0.1 % (w/w) to about 0.5% (w/w) of an emulsifying agent; and optionally about 0.1 % (w/w) to about 1% (w/w/
  • the hard molded lozenge comprises the compositions as described in Example 21.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract; about 40% (w/w) to about 60% of one or more oligosaccharides; about 40% (w/w) to about 60% of one or more polysaccharides; about 3 % (w/w) to about 6% (w/w) of the one or more plasticizers; optionally about 0.1 % (w/w) to about 0.5% (w/w) of an emulsifying agent; and optionally about 0.1 % (w/w) to about 1 % (w/w) of a flavourant.
  • the cannabinoid extract comprises about 0.1 mg to about 10mg of THC. In an embodiment, the cannabinoid extract comprises about 10mg of THC. In an embodiment, the hard molded lozenge comprises about 40% (w/w) to about 50 % (w/w) of one or more oligosaccharides selected from fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylo-oligosaccharides, isolmalto- oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • FOS fructo-oligosaccharides
  • GOS galacto-oligosaccharides
  • IMO isolmalto- oligosaccharides
  • raffinose family of oligosaccharides and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructo-oligosaccharides (FOS).
  • the fructooligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the hard molded lozenge comprises about 40% (w/w) to about 50% of one or more polysaccharides and the one or more polysaccharides is inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 0.5 % (w/w) of the one or more emulsifying agents selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the one or more emulsifying agents is lecithin.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 1 % (w/w) of the one or more flavourants selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w of a cannabinoid extract (e.g., cannabis distillate), about 40% (w/w) to about 60% of FOS having a degree of about 2 to about 8, about 40% (w/w) to about 60% of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater or about 10 or greater about 3% (w/w) to about 6% of glycerin, optionally about 0.1 % (w/w) to about 0.5% (w/w) of lecithin, and optionally about 0.1% (w/w) to about 1% (w/w) of peppermint oil.
  • a cannabinoid extract e.g.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 90% (w/w) to about 98% (w/w), about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w) or about 90% (w/w) to about 95% (w/w) of the hard molded lozenge.
  • the hard molded lozenge comprises about 1% to about 2% of a cannabinoid extract; about 40% (w/w) to about 60% of one or more oligosaccharides having a degree of polymerization of about 2 to about 9 selected from fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylooligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof; about 40% (w/w) to about 60% of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 10 or greater, about 4 % (w/w) to about 6% (w/w) of glycerin; about 0.1 to about 0.5% of an emulsifying agent; and optionally about 0.1 to about 1% of
  • the hard molded lozenge may also comprise further excipients used in the formation of buccal dosage forms such as carriers (e.g., lactose or corn starch) and binding agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate); disintegrants (e.g., potato starch, sodium starch glycolate, croscarmellose sodium, and crospovidone); or wetting agents (e.g., sodium lauryl sulphate).
  • carriers e.g., lactose or corn starch
  • binding agents e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose
  • fillers e.g., lactose, microcrystalline cellulose or calcium phosphate
  • disintegrants e.g., potato starch, sodium starch glycolate,
  • the Applicant has prepared hard molded lozenges comprising one or more polysaccharides such as inulin and a plasticizer such glycerin.
  • the present application also includes a hard molded lozenge comprising:
  • the hard molded lozenge comprises about 10% (w/w) to about 97.9% (w/w) of one or more polysaccharides, about 15% (w/w) to about 97.9% (w/w), about 20% (w/w) to about 97.9% (w/w), about 25% (w/w) to about 97.9% (w/w), about 30% (w/w) to about 97.9% (w/w), about 35% (w/w) to about 97.9% (w/w), about 40% (w/w) to about 97.9% (w/w), about 45% (w/w) to about 97.9% (w/w), about 50% (w/w) to about 97.9% (w/w), about 55% (w/w) to about 97.9% (w/w), about 60% (w/w) to about 97.9% (w/w), about 65% (w/w) to about 97.9% (w/w), about 70% (w/w) to
  • the hard molded lozenge comprises about 85% (w/w) to about 97.9% (w/w), about 90% (w/w) to about 97.9% (w/w), about 95% (w/w) to about 97.9% (w/w), about 96% (w/w) to about 97.9% (w/w), or about 97% (w/w) to about 97.9% (w/w) of the one or more polysaccharides). In an embodiment, the hard molded lozenge comprises about 95% (w/w) to about 97.9% % (w/w) of the one or more polysaccharides.
  • the present application includes a hard molded lozenge comprising:
  • the lozenge comprises about 2 % (w/w) to about 15% (w/w), about 2 % (w/w) to about 12% (w/w), about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the plasticizer.
  • the lozenge comprises about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizer. In an embodiment, the lozenge comprises about 5% (w/w) of the plasticizer.
  • the one or more plasticizers is selected from glycerin and polyethylene glycol and combinations thereof. In an embodiment, the one or more plasticizers is glycerin.
  • the hard molded lozenges of the application may comprise residual water resulting from the manufacturing process.
  • the buccal dosage form comprises than about 5% (w/w) or less, about 4% (w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the buccal dosage form comprises about 3%(w/w) or less, about 2%(w/w) or less, about 1% (w/w) or less, or about 0.5% (w/w) or less water on a total weight of the hard molded lozenge basis.
  • the hard molded lozenge comprises about 2 % (w/w) to about 10% (w/w), about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total weight of the hard molded lozenge basis.
  • the hard molded lozenge comprises about 2 % (w/w) to about 7% (w/w) or about 2 % (w/w) to about 5% (w/w) of monosaccharides and disaccharides on a total weight of the hard molded lozenge basis.
  • the monosaccharides and disaccharides are present as a natural component of the one or more oligosaccharides and/or formed as a by-product of the manufacturing process.
  • the hard molded lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts are as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1 :5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1 :400, about 1 :1000 to about 1:500, about 1 :1000 to about 1 :600, or about 1: 1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the hard molded lozenge of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the hard molded lozenge comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the hard molded lozenge comprises THC and CBD
  • the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the hard molded lozenge comprises 10mg of THC and 2mg of CBD.
  • the hard molded lozenge comprises equal amounts of THC and CBD. In an embodiment, the hard molded lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the hard molded lozenge comprises 2.5mg of THC and 2.5mg of CBD.
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the one or more polysaccharides are selected from the polysaccharides described above.
  • the one or more polysaccharides is inulin.
  • the buccal dosage form comprises about 0.1% (w/w) to about 97.9% (w/w) of inulin having a degree of polymerization of upto 60 and having an average degree of polymerization of about 9 or greater.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater. In an embodiment, the inulin is Orafti® inulin by Beneo Inc. (New Jersey, U.S.A).
  • the hard molded lozenge optionally further comprises one or more additives selected from, emulsifying agents, oils and/or fats, flavourants, and pH modifying agents as described above.
  • the one or more emulsifying agents are as described above.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the hard molded lozenge comprises about 1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the hard molded lozenge further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5% (w/w) to about 1%(w/w) or about 0.1 % (w/w) to about 1 % (w/w) of one or more oils and/or fats as described above. In an embodiment, the one or more oils and/or fats are as described above.
  • the one or more oils are vegetable oils.
  • the hard molded lozenge does not comprise a fat.
  • the hard molded lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the hard molded lozenge optionally comprises about 1%(w/w) or less of the one or more flavourants. In an embodiment, the hard molded lozenge optionally comprises about 0.1% (w/w) to about 1% (w/w) or about 0.5% (w/w) to about 1%(w/w) of the one or more flavourants. In an embodiment, the one or more flavourants are as described above. In an embodiment, the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises the one or more cannabinoids, and/or a cannabinoid extract as described above.
  • the present application also includes a hard molded lozenge comprising the one or more cannabinoids as described above.
  • the present application also includes a hard molded lozenge comprising the one or more cannabinoid extracts as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the present application includes a hard molded lozenge comprising:
  • (d) optionally about 0.1 (w/w) to about 3% (w/w) of one or more emulsifying agents.
  • the lozenge comprises about 2 % (w/w) to about 8% (w/w), about 4 % (w/w) to about 8% (w/w), about 3 % (w/w) to about 6% (w/w), about 4 % (w/w) to about 6% (w/w) or about 5% (w/w) of the one or more plasticizer.
  • the lozenge comprises about 5% (w/w) of the plasticizer.
  • the one or more plasticizers is glycerin.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents as described above. In an embodiment, the hard molded lozenge further comprises about 1%( w/w) or less of the one or more emulsifying agent as described above. In an embodiment, the hard molded lozenge further comprises about 0.1% (w/w) to about 2% (w/w), about 0.1% (w/w) to about 1.5% (w/w), about 0.5% (w/w) to about 1 %(w/w), or about 0. 1 % (w/w) to about 1 % (w/w) of one or more emulsifying agents as described above.
  • the hard molded lozenge optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents. In an embodiment, the hard molded lozenge optionally comprises about 0.5% (w/w) to about 1%(w/w) or about 0.5% (w/w) or less of the one or more emulsifying agents.
  • the one or more emulsifying agents are as described above.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the hard molded lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the hard molded lozenge comprises about 1%( w/w) or less of the one or more oils and/or fats. In an embodiment, the hard molded lozenge comprises about 0.1 % (w/w) to about 2 % (w/w), about 0.5% (w/w) to about 1%(w/w) or about 0.1 % (w/w) to about 1 % (w/w) of one or more oils and/or fats as described above.
  • the one or more oils and/or fats are as described above.
  • the one or more oils are vegetable oils.
  • the hard molded lozenge does not comprise a fat.
  • the hard molded lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the hard molded lozenge optionally comprises about 1%(w/w) or less of the one or more flavourants.
  • the one or more flavourants are as described above.
  • the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the Applicant has prepared hard molded lozenges comprising one or more polysaccharides such as inulin and a plasticizer such glycerin.
  • the buccal dosage forms have been prepared without any added sugars, sweeteners, or sweetening agents.
  • the hard molded lozenge comprises the composition as described in Example 20.
  • the hard molded lozenge comprises about 0.1% (w/w) to about 2% (w/w) of a cannabinoid extract; about 90% (w/w) to about 95% (w/w) of one or more polysaccharides; about 3 % (w/w) to about 6% (w/w) of the one or more plasticizers; optionally about 0.1 % (w/w) to about 0.5% (w/w)of an emulsifying agent; and optionally about 0.1 % (w/w) to about 1% (w/w) of a flavourant.
  • the cannabinoid extract comprises about 0.1mg to about 10mg of THC. In an embodiment, the cannabinoid extract comprises about 10mg of THC. In an embodiment, the hard molded lozenge comprises about 90% (w/w) to about 95% (w/w) of one or more polysaccharides wherein the one or more polysaccharides is inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater or about 10 or greater.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 0.5% (w/w) of the one or more emulsifying agents selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the one or more emulsifying agents is lecithin.
  • the hard molded lozenge comprises about 0.1 % (w/w) to about 1% (w/w) of the one or more flavourants selected from eucalyptus, peppermint oils and menthol.
  • the hard molded lozenge comprises about 1% (w/w) of a cannabinoid extract (e.g., cannabis distillate) ; about 90% (w/w) to about 95% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater; about 3% (w/w) to about 6% (w/w) of glycerin; optionally about 0.1 (w/w) to about 0.5% (w/w)of lecithin; and optionally about 0.1 %(w/w) to about 1% (w/w) of peppermint oil.
  • a cannabinoid extract e.g., cannabis distillate
  • inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater
  • about 3% (w/w) to about 6% (w/w) of glycerin optionally about 0.1 (w/w) to about 0.5% (w/w
  • the Applicant has prepared soft chew lozenges comprising one or more oligosaccharides such as fructo-oligosaccharides.
  • the present application also includes a soft chew lozenge comprising:
  • the soft chew lozenge further comprises about 5% (w/w) to about 70% (w/w), about 10% (w/w) to about 70% (w/w), about 10% (w/w) to about 65% (w/w), about 10% (w/w) to about 60% (w/w), about 10% (w/w) to about 55% (w/w), about 10% (w/w) to about 55% (w/w), about 10% (w/w) to about 50% (w/w), about 10% (w/w) to about 45% (w/w) water, about 10% (w/w) to about 40% (w/w) water about 10% (w/w) to about 35% (w/w) water, about 10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water, or about 10% (w/w) to about 20% (w/w) water In an embodiment, the soft chew lozenge further comprises about 10% (w/w) to about 30% (w/w/w), about 10% (w/
  • the present application includes a soft chew lozenge comprising the one or more cannabinoids, and/or a cannabinoid extract as described above. In an embodiment, the present application also includes a soft chew lozenge comprising the one or more cannabinoids as described above. In an embodiment, the present application also includes a soft chew lozenge comprising the one or more cannabinoid extracts as described above. In an embodiment, the one or more cannabinoid extracts is a cannabinoid distillate. In an embodiment, the one or more cannabinoids is selected from THC and CBD and combinations thereof. In an embodiment, the one or more cannabinoids is THC.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the soft chew lozenge of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the soft chew lozenge comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the soft chew lozenge comprises THC and CBD
  • the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the soft chew lozenge comprises 10mg of THC and 2mg of CBD.
  • the soft chew lozenge comprises equal amounts of THC and CBD. In an embodiment, the soft chew lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the soft chew lozenge comprises 2.5mg of THC and 2.5mg of CBD.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :900 to about 1 :5, about 1 :800 to about 1 :5, about 1 :700 to about 1:5, about 1 :600 to about 1 :5, about 1 :500 to about 1 :5, about 1 :400 to about 1 :5, about 1:300 to about 1:5, about 1 :200 to about 1 :5, about 1 :150 to about 1:5, about 1 :100 to about 1 :5, about 1 :400 to about 1 :50, about 1 :400 to about 1 :100, about 1 :300 to about 1:100, about 1 :300, about 1 :200, about 1 :150 or about 1 :100 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides
  • the buccal dosage form comprises about 15% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 20% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 25% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 30% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 40 (w/w) to about 90% (w/w) of one or more oligosaccharides, about 45% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 50% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 55% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 65% (w/w) to about 90% (w/w) of one or more oligosaccharides, about
  • the soft chew lozenge comprises about 15% (w/w), about 20% (w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w), about 45% (w/w), about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w), about 80% (w/w), about 85% (w/w), or about 90% (w/w) of the one or more oligosaccharides.
  • the soft chew lozenge comprises about 70% (w/w), about 75% (w/w) to about 80% (w/w), about 85% (w/w), or about 90% (w/w)of the one or more oligosaccharides.
  • the hard molded lozenge is comprised primarily of the one or more oligosaccharides.
  • the present application also includes a soft chew lozenge comprising:
  • the soft chew lozenge comprises about 70% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 75% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 80% (w/w) to about 90% (w/w) of one or more oligosaccharides.
  • the soft chew lozenge comprises one or more gelling agents as described above.
  • the buccal dosage form further comprises of from about 1% (w/w) to about 20% (w/w), about 1% (w/w) to about 15% (w/w), about 1 % (w/w) to about 10% (w/w), about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents.
  • the soft chew lozenge comprises of from about 1% (w/w) to about 10% (w/w), about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents.
  • the soft chew lozenge comprises of from about 1% (w/w) to about 10% (w/w) of the one or more gelling agents. In an embodiment, the soft chew lozenge comprises of from about 2% (w/w) to about 10% (w/w), or of from about 2% (w/w) to about 8% (w/w) of the one or more gelling agents. In an embodiment, the one or more gelling agent is gelatin.
  • the present application also includes a soft chew lozenge comprising about 10% (w/w) to about 90% (w/w) of one or more oligosaccharides having a degree of polymerization of about 10 or less, wherein the one or more oligosaccharides are as described above.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylooligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructo-oligosaccharides (FOS).
  • the fructo-oligosaccharide (FOS) is produced by the partial enzymatic hydrolysis from of inulin from natural sources such as from chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana or agave.
  • the FOS is produced by the partial enzymatic hydrolysis from chicory inulin.
  • FOS is prepared by enzymatic synthesis with sucrose by methods known in the art, for example, by the transfructosylation of sucrose by p-fructofuranosidases.
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6, or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 9 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In some embodiments, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the one or more oligosaccharides is fructo-oligosaccharides.
  • the fructo-oligosaccharide has a degree of polymerization of about 10 or less, about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less.
  • the fructo-oligosaccharide has degree of polymerization of about 10 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 9 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8.
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 8.
  • fructo-oligosaccharide is considered to include inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide is fructo-oligosaccharide having a DP of 2).
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is an oligosaccharide having a DP of 2.
  • fructooligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a heterogenous mixture of oligosaccharides of different DPs of about 2 to about 10 or less including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) not including inulobiose.
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component described above is fructo-oligosaccharide having a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to about 9 or about 3 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is included as a component of the naturally occurring sugars in the fructo-oligosaccharide.
  • fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component is fructooligosaccharide having a DP of about 3 to about 10 or less which comprises a heterogenous mixture of oligosaccharides of different DPs of about 3 to about 10 or less not including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) including inulobiose.
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 8% (w/w), about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 % (w/w) to about 7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7% (w/w), about 0.1 % (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 % (w/w) to about 6% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5% (w/w), about 1 % (w/w) (w/w), about 1
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 4% (w/w), about 1 % (w/w) to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to about 3% (w/w), of inulobiose on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the fructo-oligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 2 to about 10 or less comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructooligosaccharide.
  • the fructooligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 3 to about 10 or less comprises about 1 % (w/w) to about 8% (w/w) or 1% (w/w) to about 10% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the soft chew lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the soft chew lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, flavourants, and pH controlling agents as described above.
  • the soft chew lozenge optionally further comprises one or more emulsifying agents.
  • the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, about 5%(w/w) or less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less, about 9% (w/w) or less, or about 10% (w/w) or less of an emulsifying agent.
  • the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
  • the soft chew lozenge optionally further comprises one or more oils and/or fats.
  • the soft chew lozenge further comprises about 10%(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the soft chew lozenge further comprises about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 5% (w/w), about 0.1% (w/w) to about 3% (w/w) or about 0.1 % (w/w) to about 2 % (w/w) or about 0.1 % (w/w) to about 1 % (w/w) of one or more oils and/or fats as described above.
  • the soft chew lozenge further comprises from about 0.5% (w/w) to about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w) of the one or more oils and/or fats.
  • the soft chew lozenge optionally further comprises one or more pH modifying agents.
  • the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3%(w/w) or less, or about 4%(w/w) or less of the one or more pH modifying agents.
  • the soft chew lozenge comprises about 1% (w/w) or less, or about 2%(w/w) or less of the one or more pH modifying agents.
  • the soft chew lozenge optionally further comprises one or more flavourants.
  • the soft chew lozenge comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the soft chew lozenge comprises about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants.
  • the present application includes a soft chew lozenge comprising:
  • the soft chew lozenge is comprised primarily of the one or more oligosaccharides. Accordingly, in an embodiment, the present application includes a soft chew lozenge comprising:
  • the soft chew lozenge further comprises about 5% (w/w) to about 70% (w/w), about 10% (w/w) to about 70% (w/w), about 10% (w/w) to about 65% (w/w), about 10% (w/w) to about 60% (w/w), about 10% (w/w) to about 55% (w/w), about 10% (w/w) to about 55% (w/w), about 10% (w/w) to about 50% (w/w), about 10% (w/w) to about 45% (w/w) water, about 10% (w/w) to about 40% (w/w) water about 10% (w/w) to about 35% (w/w) water, about 10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water, or about 10% (w/w) to about 20% (w/w) water.
  • the soft chew lozenge further comprises about 10% (w/w) to about 30% (w/w) water, about 10% (w/w) to about 25% (w/w) water, or about 10% (w/w) to about 20% (w/w) water.
  • the soft chew lozenge comprises about 70% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 75% (w/w) to about 90% (w/w) of one or more oligosaccharides, about 80% (w/w) to about 90% (w/w) of one or more oligosaccharide.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts are as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 2 to about 10, about 2 to about 9, about 2 to about 8 or about 3 to about 8.
  • the one or more oligosaccharides are selected from fructooligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, mannooligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the soft chew lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more emulsifying agents. In an embodiment, the soft chew lozenge further comprises about 1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one or more emulsifying agents.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an embodiment, the lecithin is soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy lecithin.
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew lozenge comprises about 1.0%( w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew lozenge further comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats. In an embodiment, the one or more oils are vegetable oils. In an embodiment, the hard molded lozenge does not comprise a fat.
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more emulsifying agents and further comprises about 5% (w/w) or less of one or more oils and/or fats.
  • the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one or more emulsifying agents.
  • the soft chew lozenge further comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the soft chew lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the soft chew lozenge comprises about 1% (w/w) or less, or about 2%(w/w) or less of the one or more pH modifying agents.
  • the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof.
  • the pH modifying agent is citric acid.
  • the soft chew lozenge comprises about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants.
  • the hard molded lozenge comprises about 1%(w/w) or less of the one or more flavourants.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants.
  • the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the soft chew lozenge optionally further comprises one or more polysaccharides.
  • the one or more polysaccharides have a degree of polymerization of up to about 80 and have an average degree of polymerization of about 9 or greater.
  • the added % (w/w) of the one or more polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides in soft chew lozenge.
  • the present application includes a soft chew lozenge comprising:
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the one or more cannabinoids, and/or a cannabinoid extract, the one or more oligosaccharides and the one or more polysaccharides are present in a weight ratio of about 1 :900 to about 1 :5, about 1 :800 to about 1 :5, about 1:700 to about 1:5, about 1 :600 to about 1 :5, about 1 :500 to about 1:5, about 1 :400 to about 1 :5, about 1 :300 to about 1:5, about 1 :200 to about 1:5, about 1:150 to about 1 :5, about 1:100 to about 1:5, about 1 :400 to about 1:50, about 1 :400 to about 1 :100, about 1 :300 to about 1:100, about 1 :300, about 1 :200, about 1 :150 or about 1 : 100 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides and the one or more
  • the soft chew lozenge comprises about 0.5% (w/w) to about 80% (w/w), about 1% (w/w) to about 80% (w/w), about 5% (w/w) to about 80% (w/w), about 10% (w/w) to about 80%(w/w), about 15% (w/w) to about 80% (w/w), about 20% (w/w) to about 80% (w/w), about 25% (w/w) to about 80%(w/w), about 30% (w/w) to about 80% (w/w), about 35% (w/w) to about 80% (w/w), about 40% (w/w) to about 80%(w/w), about 45% (w/w) to about 80% (w/w), about 50% (w/w) to about 80% (w/w), about 55% (w/w) to about 80%(w/w), about 60% (w/w) to about 80% (w/w), about 65% (w/w) to
  • the soft chew lozenge comprises about 0.1% (w/w) to about 88.9% (w/w), about 0.1% (w/w) to about 80% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 50% (w/w), about 0.1% (w/w) to about 60% (w/w), about 0.1% (w/w) to about 70% (w/w), about 5% (w/w) to about
  • the soft chew lozenge comprises about 15% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 20% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 25% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 30% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 40 (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 45% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 50% (w/w) to about 89.9% (w/w) of one or more oligosaccharides, about 55% (w/w) to about 89.9% (w/w)
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w), about 60% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or about 85% (w/w) to about 90% (w/w) of the total weight of the soft chew lozenge.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 80% (w/w) or about 60% (w/w) to about 70% (w/w) of the total weight of the soft chew lozenge.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w) of the soft chew lozenge.
  • the present application includes a soft chew lozenge comprising:
  • the one or more polysaccharides are as described above.
  • the one or more polysaccharides is inulin.
  • the soft chew lozenge comprises about 0.1% (w/w) to about 80% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater.
  • the buccal dosage comprises about 0.1% (w/w) to about 80% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater, wherein the one or more oligosaccharides and the inulin combined comprise about 55% (w/w) to about 80% (w/w) of the soft chew lozenge.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater.
  • the soft chew lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, flavourants, and pH modifying agents as described above for the hard molded lozenge without one or more polysaccharides.
  • the present application also includes a soft chew lozenge comprising:
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w) of the total weight of the soft chew lozenge.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 55% (w/w) to about 90% (w/w), about 60% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 65% (w/w) to about 90% (w/w), about 70% (w/w) to about 90% (w/w), about 80% (w/w) to about 90% (w/w), or about 85% (w/w) to about 90% (w/w) of the total weight of the soft chew lozenge.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 60% (w/w) to about 80% (w/w) or about 60% (w/w) to about 70% (w/w) of the total weight of the soft chew lozenge.
  • the one or more polysaccharides are as described above. In an embodiment, the one or more polysaccharides is inulin as described above.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts are as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 2 to about 10, about 2 to about 9, about 2 to about 8 or about 3 to about 8.
  • the one or more oligosaccharides are selected from fructooligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, mannooligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10, about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10, about 2 to about 8 or about 3 to about 8.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6, or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 9 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have an average degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 2 to about 7, about 2 to about 6, about 2 to about 5, about 3 to about 10, about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In some embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the soft chew lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more emulsifying agents. In an embodiment, the soft chew lozenge further comprises about 1.0% (w/w) or less of the one or more emulsifying agents. In an embodiment, the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one or more emulsifying agents. In an embodiment, the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy lecithin [00380]
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew lozenge comprises about 1.0%( w/w) or less of one or more oils and/or fats. In an embodiment, the soft chew lozenge further comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats. In an embodiment, the one or more oils are vegetable oils. In an embodiment, the hard molded lozenge does not comprise a fat.
  • the soft chew lozenge further comprises about 5% (w/w) or less of one or more emulsifying agents and further comprises about 5% (w/w) of one or more oils and/or fats.
  • the soft chew lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, or about 4% (w/w) or less of the one or more emulsifying agents.
  • the soft chew lozenge further comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the soft chew lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the soft chew lozenge comprises about 1% (w/w) or less, or about 2%(w/w) or less of the one or more pH modifying agents.
  • the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof.
  • the pH modifying agent is citric acid.
  • the soft chew lozenge comprises about 2%(w/w) or less, or about 1%(w/w) or less of the one or more flavourants. In an embodiment, the soft chew lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants. In an embodiment, the hard molded lozenge comprises about 1%(w/w) or less of the one or more flavourants. In an embodiment, the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the Applicant has prepared compressed tablet lozenges comprising one or more oligosaccharides.
  • the present application also includes a compressed tablet lozenge comprising:
  • the compressed tablet further comprises one or more lubricants.
  • the buccal dosage form comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3% (w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more lubricants.
  • the one or more lubricants is as described above.
  • the lubricant is magnesium stearate.
  • the present application includes a compressed tablet lozenge comprising one or more cannabinoids, and/or a cannabinoid extract as described above.
  • the present application also includes a compressed table lozenge comprising one or more cannabinoids as described above.
  • the present application also includes a compressed tablet lozenge comprising one or more cannabinoid extracts as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the compressed tablet lozenge comprises about 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or 0.1 % (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the buccal dosage form comprises 3% (w/w) or less, about 2% (w/w) or less about 1% (w/w) or less, about 0.5% (w/w) or less, about 0.3% (w/w) or less, about 0.2% (w/w) or less, or about 0.1% (w/w) or less of the one or more cannabinoids, and/or a cannabinoid extract.
  • the compressed tablet lozenge comprises 0.1% (w/w) to about 3% (w/w), about 0.1% (w/w) to about 2% (w/w), or about 0.1% (w/w) to about 1% (w/w) of the one or more cannabinoids, and/or a cannabinoid extract.
  • the compressed tablet lozenge of the application can be used to administer any suitable dose of the one or more cannabinoids and/or cannabinoid extract.
  • typical doses of the one or more cannabinoids and/or cannabinoid extract may be in the range of about 0.1 mg to about 600 mg, about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 25 mg, about 0.1 mg to about 20 mg, about 0.1 mg to about 15 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, about 0.1 mg to about 2 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be in the range of about 0.1 mg to about 10 mg.
  • the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5 mg, about 2.5 mg, about 2 mg, about 1 mg, about 0.5 mg or about 0.1 mg. In an embodiment, the one or more cannabinoids and/or cannabinoid extract is THC and typical doses of THC may be about 10mg, about 5mg, about 2.5 mg, or about 0.1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 0.1 mg to about 500 mg, about 0.1 mg to about 400 mg, about 0.1 mg to about 300 mg, about 0.1 mg to about 250 mg, about 0.1 mg to about 200 mg, about 0.1 mg to about 100mg, about 0.1 mg to about 50 mg, about 0.1 mg to about 25 mg, about 0.1 mg to about 10 mg, about 0.1 mg to about 5 mg, about 0.1 mg to about 2.5 mg, or about 0.1 mg to about 1 mg.
  • the one or more cannabinoids and/or cannabinoid extract is CBD and typical doses of CBD may be in the range of about 10mg, about 5 mg, about 2.5 mg, about 1 mg or about 0.1 mg.
  • the compressed tablet lozenge comprises more than one cannabinoid and/or cannabinoid extract and the buccal dosage form comprises a combination of the suitable doses of each of the cannabinoid and/or cannabinoid extract.
  • the compressed tablet lozenge comprises THC and CBD
  • the buccal dosage form comprises a combination of the suitable doses of THC and CDB.
  • the compressed tablet lozenge comprises 10mg of THC and 2mg of CBD.
  • the compressed tablet lozenge comprises equal amounts of THC and CBD. In an embodiment, the compressed tablet lozenge comprises 5mg of THC and 5mg of CBD. In an embodiment, the compressed tablet lozenge comprises 2.5mg of THC and 2.5mg of CBD.
  • the one or more cannabinoids, and/or a cannabinoid extract and the one or more oligosaccharides are present in a weight ratio of about 1 :1000 to about 1:5, about 1 : 1000 to about 1 : 100, about 1 : 1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1:400, about 1 :1000 to about 1 :500, about 1 :1000 to about 1:600, or about 1 :1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to the one or more oligosaccharides.
  • the buccal dosage form comprises, about 85% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 95% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 96% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 97% (w/w) to about 98% (w/w), about 98% (w/w) to about 98% (w/w), about 99% (w/w) to about 98% (w/w), about 99.5% (w/w) to about 98% (w/w), about 98% (w/w) to about 98% (w/w) or about 99.8% (w/w) to about 98% (w/w) of one or more oligosaccharides.
  • the buccal dosage form comprises about 15% (w/w), about 20% (w/w), about 25% (w/w), about 30% (w/w), about 35% (w/w), about 40% (w/w), about 45% (w/w), about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w), about 80% (w/w), about 85% (w/w), about 90% (w/w), about 95% (w/w), about 96% (w/w), about 97% (w/w), about 98% (w/w), about 99% (w/w) or about 99% (w/w) or about 99% (w/w) or about 99% (w/w) or more of the one or more oligosaccharides.
  • the buccal dosage form comprises about 50% (w/w), about 55% (w/w), about 60% (w/w), about 70% (w/w), about 75% (w/w) to about 80% (w/w), about 85% (w/w), about 90% (w/w), about 95% (w/w), about 96% (w/w), about 97% (w/w), or about 98% of the one or more oligosaccharides.
  • the compressed tablet lozenge is comprised primarily of the one or more oligosaccharides.
  • the present application also includes a compressed tablet lozenge comprising:
  • the compressed tablet lozenge comprises about 85% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 95% (w/w) of one or more oligosaccharides, or about 92% (w/w) to about 95% (w/w) of one or more oligosaccharides.
  • the hard molded lozenge comprises the one or more oligosaccharides having a degree of polymerization of about 10 or less as described above.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), arabino-oligosaccharides, manno-oligosaccharides, xylooligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructo-oligosaccharides (FOS).
  • the fructo-oligosaccharide (FOS) is produced by the partial enzymatic hydrolysis from of inulin from natural sources such as from chicory, artichoke, yacon, dahlia, onion, garlic, asparagus, banana or agave.
  • the FOS is produced by the partial enzymatic hydrolysis from chicory inulin.
  • FOS is prepared by enzymatic synthesis with sucrose by methods known in the art, for example, by the transfructosylation of sucrose by p-fructofuranosidases.
  • the FOS is Orafti® P95 Oligofructose from Beneo GmbH New Jersey, U.S.A.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6, or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 9 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In some embodiments, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the one or more oligosaccharides is fructo-oligosaccharides.
  • the fructo-oligosaccharide has a degree of polymerization of about 10 or less, about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less.
  • the fructo-oligosaccharide has degree of polymerization of about 10 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 8 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 9 or less.
  • the fructo-oligosaccharide has a degree of polymerization of about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8 or less. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about
  • the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 2 to about 8.
  • the fructo-oligosaccharide has a degree of polymerization of about 3 to about 10. In an embodiment, the fructo-oligosaccharide has a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9, or about 3 to about 8. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 9. In an embodiment, the fructo-oligosaccharide has a degree of polymerization of about 3 to about 8.
  • fructo-oligosaccharide is considered to include inulobiose as a naturally occurring fibre (e.g an oligosaccharide wherein the oligosaccharide is fructo-oligosaccharide having a DP of 2).
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is an oligosaccharide having a DP of 2.
  • fructooligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component is fructo-oligosaccharide having a DP of about 2 to about 10 or less (such as about 2 to about 10, about 2 to about 9 or about 2 to about 8) which comprises a heterogenous mixture of oligosaccharides of different DPs of about 2 to about 10 or less including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) not including inulobiose.
  • fructo-oligosaccharide having a DP of, for example, 10 or less which comprises inulobiose as a natural component described above is fructo-oligosaccharide having a DP of about 3 to about 10 or less (such as about 3 to about 10, about 3 to about 9 or about 3 to about 8) wherein the inulobiose occurring as a natural component of the fructo-oligosaccharide is included as a component of the naturally occurring sugars in the fructo-oligosaccharide.
  • fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component is fructooligosaccharide having a DP of about 3 to about 10 or less which comprises a heterogenous mixture of oligosaccharides of different DPs of about 3 to about 10 or less not including inulobiose and comprises naturally occurring sugars (i.e., monosaccharides and/or disaccharides) including inulobiose.
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 8% (w/w), about 0.5 % (w/w) to about 8% (w/w), about 1 % (w/w) to about 8, about 0.1 % (w/w) to about 7% (w/w), about 0.5 % (w/w) to about 7% (w/w), about 1 % (w/w) to about 7% (w/w), about 0.1 % (w/w) to about 6% (w/w), about 0.5 % (w/w) to about 6% (w/w), about 1 % (w/w) to about 6% (w/w), about 0.1 % (w/w) to about 5% (w/w), about 0.5 % (w/w) to about 5% (w/w), about 1 % (w/w) (w/w), about 1
  • the fructo-oligosaccharide having a DP of, for example, 10 or less comprising inulobiose as a natural component comprises about 0.1 % (w/w) to about 4% (w/w), about 1 % (w/w) to about 3% (w/w), about 1.5 % (w/w) to about 3% (w/w), about 2 % (w/w) to about 3% (w/w), of inulobiose on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the fructo-oligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 2 to about 10 or less comprises about 1% (w/w) to about 8% (w/w) or about 1% (w/w) to about 5% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructooligosaccharide.
  • the fructooligosaccharide having a DP of, for example, about 10 or less or, for example, a DP of about 3 to about 10 or less comprises about 1 % (w/w) to about 8% (w/w) or 1% (w/w) to about 10% (w/w) of monosaccharides and/or disaccharides on a dry solid basis of the total weight of the fructo-oligosaccharide.
  • the compressed tablet lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the compressed tablet lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, flavourants, and pH controlling agents as described above.
  • the compressed tablet lozenge optionally further comprises one or more emulsifying agents.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, about 5%(w/w) or less, about 6% (w/w) or less, about 7% (w/w) or less, about 8%(w/w) or less, about 9% (w/w) or less, or about 10% (w/w) or less of an emulsifying agent.
  • the buccal dosage form comprises about 1% (w/w) or less, about 2%(w/w) or less, about 3% (w/w) or less, about 4% (w/w) or less, or about 5%(w/w) or less of the one or more emulsifying agents.
  • the compressed tablet lozenge comprises about 1% (w/w) or less, about 2%(w/w) or less of the one or more emulsifying agents.
  • the compressed tablet lozenge further comprises less than about 0.5% (w/w) to less than about 10% (w/w), from less than about 0.5% (w/w) to less than about 9%(w/w), from less than about 0.5% (w/w) to less than about 8%(w/w), from less than about 0.5% (w/w) to less than about 7%(w/w), from less than about 0.5% (w/w) to less than about 6%(w/w), from less than about 0.5% (w/w) to less than about 5%(w/w), from less than about 0.5% (w/w) to less than about 4%(w/w) of the one or more emulsifying agents.
  • the compressed tablet lozenge optionally comprises about 1.0%( w/w) or less of the one or more emulsifying agents.
  • the buccal dosage form optionally comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more emulsifying agents.
  • the compressed tablet lozenge optionally further comprises one or more oils and/or fats.
  • the compressed tablet lozenge comprises about 10%(w/w) or less, about 9%(w/w) or less, about 8%(w/w) or less, about 7%(w/w) or less, about 6%(w/w) or less, about 5% (w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the compressed tablet lozenge further comprises about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more oils and/or fats.
  • the compressed tablet lozenge further comprises from about 0.5% (w/w) to about 10% (w/w), from about 0.5% (w/w) to about 9%(w/w), from about 0.5% (w/w) to about 8%(w/w), from about 0.5% (w/w) to about 7%(w/w), from about 0.5% (w/w) to about 6%(w/w), from about 0.5% (w/w) to about 5%(w/w), from about 0.5% (w/w) to about 4%(w/w) of the one or more oils and/or fats.
  • the compressed tablet lozenge optionally further comprises about 1.0%(w/w) or less of one or more oils and/or fats.
  • the buccal dosage form further comprises about 0.1% (w/w) or less, about 0.2%(w/w) or less, about 0.3% (w/w) or less, about 0.4% (w/w) or less, about 0.5% (w/w) or less, about 0.6% (w/w) or less, or about 0.7% (w/w) or less of the one or more oils and/or fats.
  • the compressed tablet lozenge optionally further comprises one or more flavourants.
  • the compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more flavourants.
  • the compressed tablet lozenge comprises about 0.1% (w/w) to about 2% (w/w) or about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants.
  • the compressed tablet lozenge comprises about 0.1% (w/w), about 0.2%(w/w), about 0.3% (w/w), about 0.4% (w/w), about 0.5% (w/w), about 0.6% (w/w), or about 0.7% (w/w) of the one or more flavourants.
  • the compressed tablet lozenge optionally further comprises one or more pH modifying agents.
  • the compressed tablet lozenge comprises about 1.0%(w/w) or less of the pH modifying agent.
  • the compressed tablet lozenge further comprises about 0.1% (w/w), about 0.2%(w/w), or about 0.3% (w/w) of the pH modifying agent.
  • the present application also includes a compressed tablet lozenge comprising: (a) about 0.1% (w/w) to about 2% (w/w) of one or more cannabinoids, and/or a cannabinoid extract;
  • oils and/or fats optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or fats.
  • the compressed tablet lozenge is comprised primarily of the one or more oligosaccharides Accordingly, in an embodiment, the present application also includes a compressed tablet lozenge comprising:
  • oils and/or fats optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or fats.
  • the compressed tablet lozenge comprises about 85% (w/w) to about 98% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 95% (w/w) of one or more oligosaccharides, or about 92% (w/w) to about 95% (w/w) of one or more oligosaccharides.
  • the compressed tablet lozenge comprises about 5%(w/w) or less, about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more lubricants.
  • the one or more lubricants is as described above.
  • the one or more lubricants is magnesium stearate.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts are as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more oligosaccharides are selected from fructooligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, manno- oligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the compressed tablet lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents. In an embodiment, the compressed tablet lozenge further comprises about 1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the one or more emulsifying agents are as described above. In an embodiment, the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin. In an embodiment, the lecithin is soy lecithin or sunflower lecithin. In an embodiment, the lecithin is soy lecithin.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more of the oils and/or fats. In an embodiment, the one or more oils and/or fats are as described above. In an embodiment, the one or more oils are vegetable oils. In an embodiment, the compressed tablet lozenge does not comprise a fat.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents and further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the compressed tablet lozenge further comprises about 1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more oils and/or fats.
  • the compressed tablet lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the compressed tablet lozenge comprises about 1% (w/w) or less of the one or more pH modifying agents.
  • the one or more pH modifying agents are as described above.
  • the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof.
  • the pH modifying agent is citric acid.
  • the compressed tablet lozenge comprises about 1%(w/w) or less of the one or more flavourants. In an embodiment, the compressed tablet lozenge comprises about 0.1% (w/w) to about 2% (w/w) of the one or more flavourants. In an embodiment, the one or more flavourants are as described above. In an embodiment, the one or more flavourants are selected from eucalyptus, peppermint oils and menthol.
  • the compressed tablet lozenge may also comprise further excipients used in the formation of compressed tablet lozenge such as carriers (e.g., lactose or corn starch) and binding agents (e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or calcium phosphate); disintegrants (e.g., potato starch, sodium starch glycolate croscarmellose sodium, and crospovidone); or wetting agents (e.g., sodium lauryl sulphate).
  • carriers e.g., lactose or corn starch
  • binding agents e.g., pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose
  • fillers e.g., lactose, microcrystalline cellulose or calcium phosphate
  • disintegrants e.g., potato starch, sodium starch glycolate cro
  • the compressed tablet lozenge optionally further comprises one or more polysaccharides.
  • the one or more polysaccharides have a degree of polymerization of up to about 80 and have an average degree of polymerization of about 9 or greater.
  • the added % (w/w) of the one or more polysaccharides replaces an equal % (w/w) of the one or more oligosaccharides in the buccal dosage form.
  • the present application includes a compressed tablet lozenge comprising:
  • the one or more polysaccharides have a degree of polymerization of about 2 to about 80, about 2 to about 70, about 2 to about 60, about 3 to about 60, about 5 to about 60, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, or about 10 to about 20. In an embodiment, the one or more polysaccharides have a degree of polymerization of about 10 to about 60.
  • the one or more polysaccharides have an average degree of polymerization of about 10 or greater.
  • the one or more cannabinoids, and/or a cannabinoid extract, the one or more oligosaccharides and the one or more polysaccharides are present in a weight ratio of about 1: 1000 to about 1 :5, about 1:1000 to about 1 :100, about 1 :1000 to about 1 :200, about 1 : 1000 to about 1 :300, about 1 : 1000 to about 1 :400, about 1 : 1000 to about 1 :500, about 1 : 1000 to about 1 :600, or about 1 :1000 to about 1 :700 of the one or more cannabinoids, and/or a cannabinoid extract to one or more oligosaccharides and the one or more polysaccharides combined.
  • the compressed tablet lozenge comprises about 70% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 75% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 85% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 90% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 95% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 96% (w/w) to about 97.9% (w/w) of one or more oligosaccharides, about 97% (w/w) to about 97.9% (w/w) of one or more oligosaccharides.
  • the buccal dosage form comprises about 0.5% (w/w) to about 88% (w/w), about 1% (w/w) to about 88% (w/w), about 5% (w/w) to about 88% (w/w), about 10% (w/w) to about 88%(w/w), about 15% (w/w) to about 88% (w/w), about 20% (w/w) to about 88% (w/w), about 25% (w/w) to about 88%(w/w), about 30% (w/w) to about 88% (w/w), about 35% (w/w) to about 88% (w/w), about 40% (w/w) to about 88%(w/w), about 45% (w/w), about 88% (w/w), about 50% (w/w) to about 88% (w/w), about 55% (w/w) to about 88%(w/w), about 60% (w/w), about 88% (w/w), about 65% (w/w) to about 88%
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 90% (w/w) to about 98% (w/w) of the compressed tablet lozenge.
  • the present application includes a compressed tablet lozenge comprising:
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w), or about 90% (w/w) to about 95% of the compressed tablet lozenge.
  • the one or more polysaccharides are as described above.
  • the one or more polysaccharides is inulin.
  • the compressed tablet lozenge comprises about 0.1% (w/w) to about 88% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater.
  • the buccal dosage comprises about 0.1% (w/w) to about 88% (w/w) of inulin having a degree of polymerization of up to 60 and having an average degree of polymerization of about 9 or greater, wherein the one or more oligosaccharides and the inulin combined comprise about 90% (w/w) to about 98% of the compressed tablet lozenge.
  • the inulin has a degree of polymerization of about 2 to about 60, about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 3 to about 60, or about 10 to about 60. In an embodiment, the inulin has a degree of polymerization of about 10 to about 60. In an embodiment, the inulin has an average degree of polymerization of about 10 or greater.
  • the compressed tablet lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the hard molded lozenge optionally further comprises one or more additives selected from emulsifying agents, oils and/or fats, flavourants, gelling agents and pH modifying agents as described above for the compressed tablet lozenge without the one or more polysaccharides.
  • the present application also includes a compressed tablet lozenge comprising:
  • (f) optionally about 0.1% (w/w) to about 2% (w/w) oof one or more oils and/or fats.
  • the one or more oligosaccharides and the one or more polysaccharides combined comprise about 90% (w/w) to about 97% (w/w), about 90% (w/w) to about 96% (w/w), or about 90% (w/w) to about 95% of the compressed tablet lozenge.
  • the one or more cannabinoids, and/or a cannabinoid extract are as described above.
  • the one or more cannabinoids are as described above.
  • the one or more cannabinoid extracts are as described above.
  • the one or more cannabinoid extracts is a cannabinoid distillate.
  • the one or more cannabinoids is selected from THC and CBD and combinations thereof.
  • the one or more cannabinoids is THC.
  • the one or more oligosaccharides are selected from fructooligosaccharides (FOS), galacto-oligosaccharides (GOS), arabino-oligosaccharides, mannooligosaccharides, xylo-oligosaccharides, isolmalto-oligosaccharides (IMO), and raffinose family of oligosaccharides, and combinations thereof.
  • the one or more oligosaccharides are selected from fructo-oligosaccharides (FOS), and galacto-oligosaccharides (GOS) and combinations thereof.
  • the one or more oligosaccharides is fructooligosaccharides (FOS).
  • the one or more oligosaccharides have an average degree of polymerization of about 9 or less, about 8 or less, about 7 or less, about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6 or less, about 5 or less, about 4 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less, about 7 or less, or about 6, or about 5 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 9 or less, about 8 or less, about 7 or less or about 6 or less or about 5 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 9 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9 or less.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8 or less. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 2 to about 8, about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9, about 3 to about 9, about 2 to about 8 or about 3 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 2 to about 9.
  • the one or more oligosaccharides have a degree of polymerization of about 2 to about 8. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 10. In an embodiment, the one or more oligosaccharides have a degree of polymerization about 3 to about 9, about 3 to about 8, about 3 to about 7, about 3 to about 6, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, about 3 to about 8, or about 3 to about 5. In an embodiment, the one or more oligosaccharides have a degree of polymerization of about 3 to about 9, or about
  • the one or more oligosaccharides have a degree of polymerization of about 3 to about 9. In some embodiments, the one or more oligosaccharides have a degree of polymerization of about 3 to about 8.
  • the compressed tablet lozenge is free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the compressed tablet lozenge comprises about 4%(w/w) or less, about 3%(w/w) or less, about 2%(w/w) or less, or about 1%(w/w) or less of the one or more lubricants.
  • the one or more lubricants is as described above.
  • the one or more lubricants is magnesium stearate.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents. In an embodiment, the compressed tablet lozenge further comprises about 1.0%(w/w) or less of the one or more emulsifying agents.
  • the one or more emulsifying agents are as described above.
  • the one or more emulsifying agents are selected from gum Arabic, modified gum Arabic, lecithins, hydroxylated lecithin, and hydrolyzed lecithin.
  • the lecithin is soy lecithin or sunflower lecithin.
  • the lecithin is soy lecithin.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more oils and/or fats. In an embodiment, the one or more oils and/or fats are as described above. In an embodiment, the one or more oils are vegetable oils. In an embodiment, the compressed tablet lozenge does not comprise a fat.
  • the compressed tablet lozenge further comprises about 2% (w/w) or less of one or more emulsifying agents and further comprises about 2% (w/w) or less of one or more oils and/or fats. In an embodiment, the compressed tablet lozenge further comprises about 1.0%(w/w) or less of the one or more emulsifying agents. In an embodiment, the compressed tablet lozenge comprises about 1.0%(w/w) or less of the one or more emulsifying agents and further comprises about 1% (w/w) or less of one or more oils and/or fats.
  • the compressed tablet lozenge optionally further comprises one or more additives selected from flavourants, and pH controlling agents as described above.
  • the compressed tablet lozenge comprises about 1% (w/w) or less of the one or more pH modifying agents.
  • the one or more pH modifying agents are as described above.
  • the one or more pH modifying agents are selected from citric acid, malic acid, tartaric acid and ascorbic acid and combinations therefore, and salts thereof.
  • the pH modifying agent is citric acid.
  • the compressed tablet lozenge comprises about 1%(w/w) or less of the one or more flavourants. In an embodiment, the compressed tablet lozenge comprises about 0.1% (w/w) to about 1% (w/w) of the one or more flavourants. In an embodiment, the one or more flavourants are as described above. In an embodiment, the one or more flavourants are selected from eucalyptus, peppermint oils and menthol. [00455] The Applicant has found that the buccal dosage forms of the application comprising one or more oligosaccharides such as fructo-oligosaccharide provide a satisfying tactile or “mouth feel” and/or a pleasant flavor experience. Therefore, the buccal dosage forms of the application promote retention time of the dosage form in the oral cavity of a subject. In an embodiment, retention of the dosage form in the oral cavity of a subject increases bioavailability and bypasses first pass metabolism.
  • the Applicant has found that otherwise identical buccal dosage forms except wherein the one or more oligosaccharides are replaced by polysaccharides such as inulin as defined herein were difficult to manufacture due to lower rate of dissolution, high resulting viscosity in solution, high temperature of solidification and rapid rate of solidification.
  • the one or more oligosaccharides could be used without difficulty in preparing the buccal dosage forms of the application and without added sugars, sweeteners, and/or sweetening agents to aid in the manufacturing process.
  • the buccal dosage forms of the application comprising one or more oligosaccharides to provide both a satisfying tactile or “mouth feel” and/or a pleasant flavor experience and manufacturing workability, including favourable rate of dissolution, low resulting viscosity in solution, low temperature of solidification and slow rate of solidification, without added sugars, sweeteners, or sweetening agents.
  • the buccal dosage forms comprising one or more oligosaccharides provide a more favourable dissolution profile compared to an otherwise identical buccal dosage forms except wherein the one or more oligosaccharides is completely replaced by one or more polysaccharides such as inulin and/or by sugar.
  • the hard molded lozenge described herein can take from about 5 minutes to about 25 minutes to dissolve when placed in a subject’s mouth and dissolved by passive incubation in the oral cavity. In an embodiment, the hard molded lozenge described herein can take from about 8 minutes to about 20 minutes to dissolve when placed in a subject’s mouth and dissolved by passive incubation in the oral cavity. In an embodiment, about 60 to about 90% of the lozenge dissolves after 20 minutes.
  • One or more plasticizers such as glycerin and/ or one or more polysaccharides such as inulin as used herein may be used to vary the rate of dissolution.
  • the buccal dosage forms including hard molded lozenges, soft chew lozenges an compressed tablets of the application may, for example, be useful for the treatment and prevention of various diseases, disorders or conditions that benefit from treatment with one or more cannabinoids and/or cannabinoid extracts.
  • the present application also includes a method of treating diseases, disorders or conditions that benefit from treatment from one or more cannabinoids and/or cannabinoid extract, the method comprising administering a buccal dosage form of the application to a subject in need thereof.
  • the present application also includes a use of one or more buccal dosage forms of the application as described above for treating diseases, disorders or conditions that benefit from treatment from one or more cannabinoids and/or cannabinoid extract, as well as a use of one or more buccal dosage forms of the application for the preparation of a medicament treating diseases, disorders or conditions that benefit from treatment from one or more cannabinoids and/or cannabinoid extract.
  • the application further includes a use of one or more buccal dosage forms of the application for use in treating diseases, disorders or conditions that benefit from treatment from one or more cannabinoids and/or cannabinoid extract.
  • the one or more diseases, disorders or conditions that benefit from treatment one or more cannabinoids and/or cannabinoid extract is selected from inflammatory bowel disease (IBS), Crohn's disease(CD), irritable bowel syndrome (IBS), ulcerative colitis (UC), nausea, vomiting, anorexia, cachexia, pain including acute, chronic, and neuropathic pain, gastrointestinal tract distress, migraine headaches, postmenstrual syndrome (PMS), cancer, neurodegenerative diseases like Lou Gehrig's disease, Huntington's disease, Alzheimer's dementia, Parkinson's disease and Parkinsonian-type symptoms, spinal-cord injuries; HIV/AIDS, agitation, insomnia, depression, muscle spasms, spasticity from multiple sclerosis, glaucoma, Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Post- Traumatic Stress Disorder (PTSD), and anxiety disorders.
  • IBS inflammatory bowel disease
  • CD Crohn's disease
  • IBS irritable bowel syndrome
  • UC ulcerative colitis
  • the subject is a mammal. In some embodiments, the subject is human.
  • Treatment methods comprise administering to a subject a buccal dosage form of the application that comprises a therapeutically effective amount of one or more cannabinoids and/or cannabinoid extract and optionally consist of a single administration, or alternatively comprise a series of administrations.
  • the buccal dosage form of the application may be administered at least once a week.
  • the buccal dosage form may be administered to the subject from about one time per three weeks, or about one time per week to about once daily for a given treatment.
  • the buccal dosage forms are administered 2, 3, 4, 5 or 6 times daily.
  • the length of the treatment period depends on a variety of factors, such as the severity of the disease, disorder or condition, the age of the subject, the concentration and/or the activity of the formulations of the application, and/or a combination thereof. It will also be appreciated that the effective dosage of the buccal dosage form used for the treatment may increase or decrease over the course of a particular treatment regime. Changes in dosage may result and become apparent by standard diagnostic assays known in the art. In some instances, chronic administration may be required. For example, the formulations are administered to the subject in an amount and for duration sufficient to treat the patient. IV.
  • the present application also includes methods of preparing the buccal dosage forms of the application.
  • the buccal dosage form is a lozenge, such as a hard molded lozenge, a soft chew lozenge or a compressed tablet lozenge.
  • the present application includes a method of preparing hard molded lozenges of the application as described above comprising:
  • the method further comprises adding one or more plasticizers with mixing to the cooled oligosaccharide mixture in step (d).
  • the method further comprises adding one or more plasticizers, all or in part, with heating in step (b) prior to reaching the suitable temperature.
  • the one or more cannabinoids, and/or a cannabinoid extract are heated before adding to the oligosaccharide mixture in step (d). In an embodiment, the one or more cannabinoids, and/or a cannabinoid extract are heated to about 65-85°C.
  • the method comprises (d) mixing the one or more cannabinoids, and/or a cannabinoid extract with the one or more emulsifying agents and/or one or more oils and/or fats to form a cannabinoid mixture, and adding the cannabinoid mixture to the to the oligosaccharide mixture to obtain a bulk lozenge product.
  • a suitable amount of water is used in step (a).
  • a suitable amount of water is an amount of water sufficient to dissolve the one or more oligosaccharides.
  • the suitable amount of water is about 25% wt. to about 50% wt., about 25% wt. to about 40% wt., about 30% wt. to about 40% wt. or about 30% wt. to about 35% wt. of the total weight of the one or more oligosaccharides.
  • the oligosaccharide mixture is heated to a temperature of about 280- 310°F. In an embodiment, the oligosaccharide mixture is heated for a time sufficient to evaporate substantially the entire amount of water.
  • substantially the entire amount of water means about 5% (w/w) or less, about 4% (w/w) or less, about 3% (w/w) or less, about 2% (w/w) or less, or about 1 % (w/w) or less of water to the total mass of the hard molded lozenge remains in the hard molded lozenge composition.
  • the method further comprises mixing the one or more polysaccharides with the one or more oligosaccharides with the water in step (a).
  • step (a) comprises mixing the one or more polysaccharides with water to obtain an polysaccharides mixture and step (b) to (e) are performed with the polysaccharides mixture.
  • the one or more cannabinoids, and/or a cannabinoid extract is mixed with the one or more emulsifying agents and/or one or more oils and/or fats to form a homogenous cannabinoid mixture.
  • the method further comprises adding one or more flavourants and/or one or more pH modifying agents to the oligosaccharide mixture in step (d).
  • the oligosaccharide mixture is cooled to about 260 to about 280°F.
  • the bulk lozenge product is mixed to obtain a homogenous bulk lozenge product.
  • the step of shaping or molding the bulk lozenge product is by pouring the bulk lozenge product into suitable molds.
  • the suitable molds are silicone molds.
  • the suitable molds are composed of rigid material that is coated with a non-stick coating.
  • the suitable molds are coated with a suitable release agent.
  • the method further comprises cooling the bulk lozenge product to a temperature suitable for shaping.
  • the temperature suitable for shaping is selected to be compatible with the shaping method.
  • the step of shaping or molding the bulk lozenge product is by mechanical or manual shaping.
  • the mechanical shaping is performed using a rope former, drop roller press and/or pillow cutter.
  • the manual shaping is by folding, rolling and cutting the bulk lozenge product into desired shapes.
  • the step of shaping the bulk lozenge product is performed using a drop roller press.
  • the bulk lozenge is cooled to a temperature of about 70°C.
  • the step of shaping or molding the bulk lozenge product is performed using a drop roller press to provide round hard molded lozenges.
  • the step of shaping or molding the bulk lozenge product is by pouring the homogenous bulk lozenge product into a heated manual or mechanical depositor system, followed by depositing into suitable molds.
  • the depositing into suitable molds is performed at a suitable temperature.
  • the suitable temperature for depositing is a temperature that provides a bulk lozenge product of suitable viscosity for dispensing the bulk lozenge product from a depositor.
  • the suitable temperature for depositing is about 212°F to about 280°F.
  • the method further comprises the step of finishing the hard molded lozenges.
  • the step of finishing comprises applying a coating, deburring any sharp edges, polishing and the like.
  • the polishing is performed using a jewelry tumbler.
  • the present application includes hard molded lozenges prepared by the methods described above.
  • the hard molded lozenges of the application are hermetically sealed.
  • the hard molded lozenges comprising a plasticizer are packaged in blister pack or heat-sealed pouch.
  • the Applicant has found that rework resulting form the preparation of the hard lozenge buccal dosage forms of the application can be simply and efficiently reheated and remolded or incorporated into a single new batch with essentially no loss of product. Accordingly, the present application also includes a method of reclaiming rework produced from preparing the hard molded lozenges of the application produced comprising: heating the rework produced from preparing the hard molded lozenges of the application to a suitable temperature to melt the rework to provide a bulk lozenge product; optionally cooling the bulk lozenge product to temperature suitable for shaping; and shaping or molding the bulk lozenge product to form the hard molded lozenges.
  • the rework is heated to a temperature of about 70°C to about 100°C, 80°C to about 100°C or about 90°C to about 100°C. In an embodiment, the rework is heating until melted. In an embodiment, the rework is heated until molten.
  • the temperature suitable for shaping is as described above for the hard molded lozenges of the application.
  • the shaping or molding of the bulk lozenge product is as described above for the hard molded lozenges of the application.
  • the present application also includes hard molded lozenges prepared by the method of reclaiming rework described above.
  • the present application also includes a method of preparing soft chew lozenges of the application as described above comprising: (a) mixing the one or more gelling agents wherein the gelling agent is gelatin with water and allowing the gelling agent to hydrate to form a gelling mixture;
  • the method comprises (d) mixing the one or more cannabinoids, and/or a cannabinoid extract to form a cannabinoid mixture, and the cannabinoid mixture is added to the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide mixture.
  • the gelling agent is allowed to hydrate for about 10 minutes, about 20 minutes, about 30 minutes, about 40 minutes, about 50 minutes or about 60 minutes. In an embodiment, the gelling agent is allowed to hydrate for about 30 minutes.
  • the oligosaccharide/gelling mixture is heated to a temperature of about 30°C to about 60°C.
  • the one or more polysaccharides is mixed with the oligosaccharides in step (b).
  • the one or more cannabinoids, and/or a cannabinoid extract is mixed with the one or more emulsifying agents and/or one or more oils and/or fats to form a homogenous cannabinoid mixture.
  • the method further comprises adding one or more flavourants and/or one or more pH modifying to the oligosaccharide mixture in step (d).
  • the cannabinoid/oligosaccharide mixture is mixed to obtain a homogeneous cannabinoid/oligosaccharide mixture.
  • the step of shaping the cannabinoid/oligosaccharide mixture is by pouring the cannabinoid/oligosaccharide into suitable molds.
  • the suitable molds are silicone molds.
  • the present application also includes a method for preparing soft chew lozenges of the application as described above comprising: (a) mixing one or more gelling agents wherein the gelling agent is gelatin with water and allowing the gelling agent to hydrate to form a gelling mixture;
  • the method comprises (d) mixing the one or more cannabinoids, and/or a cannabinoid extract with one or more emulsifying agents and/or one or more oils and/or fats to form a cannabinoid mixture, and the cannabinoid mixture is then added to the to the oligosaccharide mixture to obtain a cannabinoid/oligosaccharide mixture.
  • the gelling agent is allowed to hydrate for about 10 minutes, about 20 minutes, about 30 minutes, about 40 minutes, about 50 minutes or about 60 minutes. In an embodiment, the gelling agent is allowed to hydrate for about 30 minutes.
  • the oligosaccharide mixture is heated to a temperature of about 30°C to about 60°C.
  • the one or more polysaccharides is mixed with the one or more oligosaccharides in step (b).
  • the one or more cannabinoids, and/or a cannabinoid extract is mixed with the one or more emulsifying agents and/or one or more oils and/or fats to form a homogenous cannabinoid mixture.
  • the one or more emulsifying agent facilitates the mixing of the one or more cannabinoids, and/or a cannabinoid extract and the oligosaccharide mixture thereby improving the homogeneity of the cannabinoid mixture and/or cannabinoid/oligosaccharide mixture.
  • the method further comprises adding one or more flavourants and/or one or more pH modifying to the oligosaccharide mixture in step (d).
  • the cannabinoid/oligosaccharide mixture is mixed to obtain a homogenous cannabinoid/oligosaccharide mixture
  • the step of shaping the homogenous cannabinoid/oligosaccharide mixture is by pouring the homogenous cannabinoid/oligosaccharide into suitable molds.
  • the suitable molds are silicone molds.
  • Soft chew lozenge of the present application comprising gelling agent other than gelatin can be prepared by processes known in the art. The selection of a particular process to prepare a soft chew lozenge of the present agent with a gelling agent other than gelatin is within the purview of the person of skill in the art.
  • the present application includes soft chew lozenges prepared by the methods described above.
  • the present application also includes a method of preparing compressed tablet lozenges of the application as described above comprising:
  • the one or more cannabinoids, and/or a cannabinoid extract is warmed to a liquid state before combining with the one or more oligosaccharides.
  • the one or more cannabinoids, and/or a cannabinoid extract is warmed to about 60 °C to about 90°C.
  • the method comprises (a) mixing one or more cannabinoids, and/or a cannabinoid extract with one or more emulsifying agents and/or one or more oils and/or fats to form a cannabinoid mixture, and combining with about 10% (w/w) to about 98% (w/w) of one or more oligosaccharides having a degree of polymerization of about 2 to about 10 to obtain an cannabinoid/oligosaccharide mixture.
  • the one or more polysaccharides is mixed with the one or more oligosaccharides in step (b).
  • the cannabinoid/oligosaccharide mixture is mixed to evenly disperse the cannabinoid/oligosaccharide mixture.
  • the method further comprises adding one or more flavourants and/or one or more pH modifying to the cannabinoid/oligosaccharide mixture.
  • one or more buccal dosage forms of the application as described herein are packaged in a variety of conventional and non-conventional manners.
  • a plurality of buccal dosage forms can be packaged in a container having a lid.
  • a plurality of buccal dosage forms is stacked and packaged in a paper, plastic, and/or aluminum foil tube.
  • the packaging can have a child-resistant lid.
  • the buccal dosage forms of the application are packaged in a blister pack or foil packet.
  • the blister pack or foil pack is contained within child resistant pouch. Accordingly, in an embodiment, the present application further comprises a package comprising one or more buccal dosage forms of the application.
  • the buccal dosage forms are selected from one or more hard molded lozenges, soft chew lozenges and compressed tablets and combinations thereof.
  • the present application includes compressed tablet lozenges prepared by the methods described above.
  • the buccal dosage forms of the application are free of added sugars, sweeteners, and/or sweetening agents as described above.
  • the buccal dosage forms of the application have less stickiness compared to an otherwise identical buccal dosage form except wherein the one or more oligosaccharides is replaced by sugar. Therefore, in an embodiment, the buccal forms of the application may be packaged without use of wrappers or a coating such as a film or sugar coating.
  • Example 1 Exemplary hard molded lozenge of the application a) Exemplary hard molded lozenge composition ranges
  • Emulsifying agents (0-1%)
  • Cannabis distillate, soy lecithin and fractionated coconut oil were combined in suitable container and mixed until homogenous.
  • Fructooligosaccharides(oligofructose) and water were combined in a heavy bottomed stainless-steel heating vessel fitted with temperature probe. The temperature of the fructooligosaccharide/water mixture was slowly raised to about 280-310°F and then removed from heat. Cannabis distillate mixture and remaining ingredients were stirred into the fructooligosaccharide/water mixture until homogenous. The fructooligosaccharide/water mixture was allowed first to cool to appropriate temperature if using temperature sensitive ingredients. For a molded lozenge, the final mixture was poured into suitable molds (ex: Silicone) (Figure 1).
  • the final mixture was poured onto a work surface and allow to cool until malleable and then processed into desired shapes using manual handling (folding, rolling, cutting) or mechanical handling (rope former/size, drop roller press, pillow cutter, etc.).
  • the lozenges were separated into individual pieces, sifted and tumbled to remove small or undersized lozenge pieces and packaged and stored in cool, dry location.
  • Example 2 Exemplary hard molded lozenge of the application optionally comprising one or more polysaccharides a) Hard molded lozenge Composition
  • Emulsifying agents (0-1%)
  • fructooligosaccharides oligofructose
  • Inulin exemplary polysaccharide (0.1-89.9%)
  • water is combined and heated until the temperature of the mixture reaches about 280-310°F.
  • the fructooligosaccharide solution is removed from heat and the cannabis extract (0.1-1%) and any remaining ingredients (for example, unsweetened flavouring agent, 0-1%) are added and mixed until homogenous.
  • the resulting liquid is shaped by pouring into suitable molds to cool (ex: Silicone).
  • the liquid is poured onto a work surface to cool until malleable then processed into desired shapes using manual (folding, rolling, cutting) or mechanical handling (rope former/sizer, drop roller press, pillow cutter, etc).
  • lozenges were separated into individual pieces, sifted/tumbled to remove small or undersized pieces (as required) and packaged/stored in a cool, dry location.
  • Example 3 Exemplary Hard molded lozenge of the Application optionally comprising one or more emulsifying agents a) Hard molded lozenge Composition
  • Emulsifying agents (0-1%)
  • Cannabis extract (0.1-1%) and soy lecithin (exemplary emulsifier (0-1%)) are combined in a suitable container and mixed until homogenous.
  • Fructooligosaccharide/oligofructose exemplary oligosaccharide ( 10%-99.8%)
  • Inulin exemplary polysaccharide (0.1-90%)
  • water are combined and heated until the temperature of the mixture reaches 280-310°F.
  • the fructooligosaccharide solution is removed from heat and the cannabis extract solution and any remaining ingredients (for example, unsweetened flavouring agent, 0-1%) are added and mixed until homogenous.
  • the resulting liquid is shaped by pouring into suitable molds to cool (ex: Silicone). Alternatively, the liquid is poured onto a work surface to cool until malleable then processed into desired shapes using manual (folding, rolling, cutting) or mechanical handling (rope former/sizer, drop roller press, pillow cutter, etc.). Once cooled to room temperature, lozenges were separated into individual pieces, sifted/tumbled to remove small or undersized pieces (as required) and packaged/stored in a cool, dry location.
  • Example 4 Exemplary hard molded lozenge of the application optionally comprising one or more emulsifying agents and one or more oils/fats a) Hard molded lozenge Composition
  • Emulsifying agents (0-1%)
  • Cannabis extract (0.1-1%), soy lecithin (exemplary emulsifier (0-1%)), and fractionated coconut oil (Vegetable or animal fat/oil (0-1%)) are combined in a suitable container and mixed until homogenous.
  • Fructooligosaccharide oligofructose
  • Inulin exemplary polysaccharide (0.1-89.9%)
  • water is combined and heated until the temperature of the mixture reaches about 280-310°F.
  • the fructooligosaccharide solution was removed from heat and the cannabis extract solution and any remaining ingredients (ex: unsweetened flavouring agent, 0-1%) were added and mixed until homogenous.
  • the resulting liquid is shaped by pouring into suitable molds to cool (ex: Silicone). Alternatively, the liquid is poured onto a work surface to cool until malleable then processed into desired shapes using manual (folding, rolling, cutting) or mechanical handling (rope former/sizer, drop roller press, pillow cutter, etc.). Once cooled to room temperature, lozenges are separated into individual pieces, sifted/tumbled to remove small or undersized pieces (as required) and are packaged/stored in a cool, dry location.
  • Example 5 Exemplary hard molded lozenge of the application optionally comprising one or more oils/fats a) Hard molded lozenge Composition
  • Emulsifying agents (0-1%)
  • Cannabis extract and fractionated coconut oil are combined in a suitable container and mixed until homogenous.
  • Fructooligosaccharide/oligofructose exemplary oligosaccharide (10%-99.8%)
  • Inulin exemplary polysaccharide (0.1-89.9%)
  • water are combined and heated until the temperature of the mixture reaches 280-310°F.
  • the fructooligosaccharide solution is removed from heat and the cannabis extract mixture and any remaining ingredients (for example, unsweetened flavouring agent, 0-1%) are added and mixed until homogenous.
  • the resulting liquid is shaped by pouring into suitable molds to cool (ex: Silicone). Alternatively, the liquid is poured onto a work surface to cool until malleable then processed into desired shapes using manual (folding, rolling, cutting) or mechanical handling (rope former/sizer, drop roller press, pillow cutter, etc.). Once cooled to room temperature, lozenges are separated into individual pieces, sifted/tumbled to remove small or undersized pieces (as required) and are packaged/stored in a cool, dry location

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Abstract

La présente demande concerne des formes galéniques buccales comprenant un ou plusieurs cannabinoïdes et/ou extraits de cannabinoïdes et un ou plusieurs oligosaccharides tels qu'un fructo-oligosaccharide seul ou en association avec un ou plusieurs polysaccharides tels que l'inuline, et comprenant éventuellement un plastifiant tel que la glycérine. La présente demande concerne également des formes galéniques buccales comprenant un ou plusieurs polysaccharides tels que l'inuline et un plastifiant. Les formes galéniques buccales incluent les pastilles moulées dures, les pastilles à mâcher molles et les comprimés compressés. Le ou les cannabinoïdes et/ou extraits de cannabinoïdes incluent le cannabidiol (CBD) et le tétrahydrocannabinol (THC). La présente demande concerne également des formes galéniques buccales qui sont sans sucres ajoutés, édulcorants et/ou agents édulcorants. Des procédés de préparation des formes galéniques buccales sont également compris.
PCT/CA2021/051161 2020-08-21 2021-08-20 Formes galéniques buccales comprenant des oligosaccharides Ceased WO2022036462A1 (fr)

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WO2018065479A1 (fr) * 2016-10-04 2018-04-12 Full Spectrum Laboratories Ltd Produits de chicorée contenant des cannabinoïdes
WO2019245639A1 (fr) * 2018-06-23 2019-12-26 Poviva Tea, Llc Amélioration de l'administration d'agents actifs lipophiles à travers la barrière hémato-encéphalique et méthodes de traitement de troubles du système nerveux central
WO2020015816A1 (fr) * 2018-07-16 2020-01-23 Symrise Ag Composition de substitution de sucre dans les pâtisseries

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Publication number Priority date Publication date Assignee Title
CA2480270A1 (fr) * 2002-04-03 2003-10-09 Solvay Pharmaceuticals B.V. Formulation de cannabinoide naturel stabilise
WO2018065479A1 (fr) * 2016-10-04 2018-04-12 Full Spectrum Laboratories Ltd Produits de chicorée contenant des cannabinoïdes
WO2019245639A1 (fr) * 2018-06-23 2019-12-26 Poviva Tea, Llc Amélioration de l'administration d'agents actifs lipophiles à travers la barrière hémato-encéphalique et méthodes de traitement de troubles du système nerveux central
WO2020015816A1 (fr) * 2018-07-16 2020-01-23 Symrise Ag Composition de substitution de sucre dans les pâtisseries

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11992497B2 (en) 2021-08-04 2024-05-28 Demeetra Agbio, Inc. Cannabinoid derivatives and their use
US12433903B2 (en) 2021-08-04 2025-10-07 Demeetra Agbio, Inc. Cannabinoid derivatives and their use

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