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WO2022091051A1 - Compositions et émulsions de cannabis - Google Patents

Compositions et émulsions de cannabis Download PDF

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Publication number
WO2022091051A1
WO2022091051A1 PCT/IB2021/060080 IB2021060080W WO2022091051A1 WO 2022091051 A1 WO2022091051 A1 WO 2022091051A1 IB 2021060080 W IB2021060080 W IB 2021060080W WO 2022091051 A1 WO2022091051 A1 WO 2022091051A1
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WO
WIPO (PCT)
Prior art keywords
emulsion
extract
cannabis
edible
thc
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Ceased
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PCT/IB2021/060080
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English (en)
Inventor
Stephen Barnhill
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Ai Pharmaceuticals Jamaica Ltd
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Ai Pharmaceuticals Jamaica Ltd
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Filing date
Publication date
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Publication of WO2022091051A1 publication Critical patent/WO2022091051A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • 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
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/071—Agaricus
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/074—Ganoderma
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • 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

Definitions

  • compositions comprising Cannabis extracts. More particularly this relates to nutraceutical and / or pharmaceutical compositions comprising cannabis extracts, and methods of preparing emulsions therefrom.
  • Cannabis spp. have been used medicinally for centuries. Their therapeutic value is the subject of many current studies. Beneficial effects have been shown or reported for many conditions, including cancer, viral infections, inflammation, and certain neurological conditions. It is now well established that the mammalian endocannabinoid system can be affected by exogenous cannabinoids, including plant-derived cannabinoids. The use of exogenous cannabinoids and their ability to regulate (particularly up-regulate) the endocannabinoid system in humans is being studied as a therapeutic approach.
  • Cannabinoids such as delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are major cannabinoids from Cannabis spp. More minor cannabinoids are continually being discovered, and we are learning more about the vast array of cannabinoids in plants. Our understanding of the role and potential therapeutic value of such compounds is ongoing.
  • THC delta-9-tetrahydrocannabinol
  • CBD cannabidiol
  • compositions generally comprising extracts of cannabis.
  • the compositions are useful for treating multiple conditions.
  • the compositions in certain embodiments are prepared as emulsions,
  • distillates containing major cannabinoids are now known to be primarily oil-soluble compounds with low or no solubility in water or aqueous solutions.
  • adding any water-soluble compounds to compositions comprising oil-soluble cannabis extracts creates problems such as insolubility, precipitation, gel-formation, and the like.
  • problems can result in decreased ability to deliver compounds, quality issues (particularly with appearance and performance), fouling or blocking of production equipment, lack of acceptability for administration through various routes, decreased absorption, and decreased biological activity or bioavailability. Accordingly, the inventor has discovered that certain compositions have improved properties when prepared as emulsions.
  • emulsions are colloidal dispersions of one liquid into another in which it is not soluble or miscible. These systems then include a “continuous phase” and a “dispersed” (or discontinuous) phase. Emulsions typically appear cloudy or even opaque because the interfaces between the smaller dispersed droplets and the continuous phase scatter light. Some emulsions appear white when the light is scattered throughout and does not pass through. Milk is a good example of an emulsion where the fat droplets (i.e., cream) are dispersed in the aqueous phase.
  • emulsions like milk can be considered oil-in-water emulsions (or "O/ W") emulsions where the dispersed phase is named first.
  • butter is a water-in-oil (W / O) emulsion with small droplets of dispersed into a continuous oil phase.
  • Stabilization can generally happen in a number of ways.
  • One simple way to is to increase the viscosity of the continuous phase. That will enhance stability by slowing down the rate at which the discontinuous phase can e.g., aggregate and separate.
  • Another way to stabilize emulsions is to reduce the surface tension between the continuous phase and the dispersed phase - i.e., at the interface. Adding compounds such as emulsifiers and detergents can help reduce the forces driving the emulsion to separate, particularly at the interfaces. Compounds with both hydrophilic and hydrophobic properties can be distributed at the interface. Examples include proteins, gums, soaps, salts of fatty acids, long chain alcohols, and the like. Mono- and di- glycerides can also serve as effective emulsifiers.
  • compositions provided herein can be emulsified by a variety of techniques based on the specific properties of the compositions and based on whether an O/ W or W/O emulsion is preferred.
  • the emulsions comprise droplet size of several microns to ⁇ 200 microns. In preferred embodiments, the droplet size is less than about 100 microns. More preferred presently are emulsions with average droplet sizes of about 80, 70, 60, or even 50 microns or less. The inventors have found that it can be difficult to consistently produce emulsions with droplet diameters of less than about 10 or 20 microns. [16] It is also to be noted that not only the average size of the droplets, but the range of droplet size is important. Even a relatively low percentage of larger droplets can destabilize an otherwise useful emulsion.
  • an emulsion with an average droplet size of 20 microns, a range of about 2 microns to about 50 microns, and a median droplet size of 18 microns is likely to be more stable than an emulsion with an average droplet size of 10 microns, a range of about 2 microns to about 200 microns, and a median droplet size of 25 microns.
  • emulsions made according to the instant disclosure are shelf stable at room temperature and/or at refrigerator temperature for at least several weeks to about 12 months. Shelf-life of less than a few weeks makes commercial distribution difficult without additional techniques or methods.
  • the oil phase of the compositions disclosed here typically comprises Cannabis extracts
  • the aqueous phase can comprise other useful compounds.
  • edible and medical mushrooms are reported to provide many beneficial and therapeutic properties. While any part of the mushroom may be useful and provide beneficial properties, water-soluble or aqueous extracts have most frequently been reported on. Extracting oil soluble mushroom components and combining them with oil-soluble Cannabis extracts should be reasonably straight forward for the ordinarily skilled artisan in the art of making such extracts.
  • the inventors have discovered that making compositions comprising both oil-soluble Cannabis extracts and water-soluble mushroom extracts is facilitated by use of emulsions, of either the O/ W type or the W/O type.
  • the mushroom or mushroom extract(s) present in the compositions is from any edible or medicinal mushroom species.
  • the edible or medicinal mushroom in various embodiments comprises one or more of Agaricus bisporus, A. blazei, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, A. confluens, Amanita muscaria, Antrodia camphorate, Boletus badius, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Caripia Americansi, Clitocybe maxima, Cordyceps cicadicola, C. gunnii, C.
  • liangshanensis C. militaris, C. pruinose, C. sinensis, Cyathus africanus, C. hookeri, Daldinia childiae, Dictyophora indusiata (synonym: Phallus indusiatus), Elaphomyces granulatus, Flammulina velutipes, Pomes fomentarius, Fomitopsis pinicola, Funalia trogii, Ganoderma lucidum, Geastrum saccatum, Grifola frondosa, Hericium erinaceus, Inocybe umbrinella, Inonotus olbiquus, Eactarius deliciosus, L. flavidulus, L.
  • the mushrooms include any one or more of Turkey Tail, Reishi, Shitake, Chaga, Cordyceps, Maitake, Lions Mane, Cubensis, or Reishi. Any part(s) of the mushrooms may be used herein and at any stage or cycle of the mushroom (not limited to fruiting bodies).
  • the cannabis extracts may include any cannabinoids and can be derived from any Cannabis spp.
  • the cannabis extracts may further comprise any number of useful terpenes and/or flavonoids.
  • a presently preferred strain of Cannabis is Ringo's Gift.
  • compositions optionally include other nutraceutical or botanical compounds to provide additional.
  • examples include compound such as herbal extracts from one or more of Rehmanniae spp., Achyranthis spp., Corni spp., Moutan spp., Alismatis spp., Dioscorea spp., Plantaginis spp., Hoelen spp., Aconiti spp., Cinnamomi spp., Barosma betulina, Galium aparine, cornsilk from Zea mays, horsetail (Equisetum spp.), resiniferatoxin (or extract from Euphorbia resinifera), capsaicin, saw palmetto, bearberry, cranberry, St.
  • compound such as herbal extracts from one or more of Rehmanniae spp., Achyranthis spp., Corni spp., Moutan spp., Alismatis spp.,
  • Additional compounds contemplated for use herein comprise S-adenosylmethionine, methylfolate, polyphenols, D-mannose, antioxidants, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically available form thereof, or combinations thereof.
  • the combinations may further optionally comprise one or more solvents, including but not limited to dimethyl sulfoxide or related amphipathic solvents, or other solvent capable of dissolving poorly soluble polar and non-polar molecules and which are relatively nontoxic in mammals and specifically humans.
  • solvents including but not limited to dimethyl sulfoxide or related amphipathic solvents, or other solvent capable of dissolving poorly soluble polar and non-polar molecules and which are relatively nontoxic in mammals and specifically humans.
  • dihydrolevoglucosenone cyrene sold commercially as "GYRENE”
  • GYRENE dihydrolevoglucosenone cyrene
  • compositions comprising an extract from one or more edible or medicinal mushrooms, or a cannabis extract, or combinations of the foregoing, has many benefits for therapeutic use.
  • the compositions have useful properties, such as effectiveness including over a long period of time, low toxicity, no serious side effects, and good tolerance on the part of a wide range of subjects.
  • the compositions also appear to have excellent biological activity in a variety of applications.
  • compositions comprising Cannabis for therapeutic uses.
  • Emulsions comprising the compositions and methods for preparing such emulsions are also provided.
  • the compositions allow a modern practitioner to utilize the therapeutic benefits of Cannabis in conveniently administered or utilized forms.
  • compositions in certain embodiments can further comprise certain useful compounds found in edible and medicinal mushrooms (such as used for centuries in Chinese and other traditional medicine practices, and by e.g., herbalists throughout the world), with the positive benefits of another natural substance, cannabis, also used for centuries.
  • the compositions further include certain beneficial compounds derived from Cannabis and other natural or synthetic sources, and other nutraceutical or pharmaceutical compounds, particularly nutraceutical compounds known to be supportive of various health conditions. Used properly, these compositions have little risk, few side effects, and are effective for producing measurable and lasting results in patients suffering from a variety of conditions.
  • Medical mushrooms as used herein means any mushroom species that has been used traditionally or in modern times as a source of medicinal or therapeutic benefits, healing properties, and / or healthful compounds. It should be noted that the medicinal mushrooms may not be edible in all embodiments herein, and may in fact be poisonous if eaten, however, one or more extracts therefrom or components extracted or isolated therefrom may be perfectly useful herein.
  • mushrooms that are edible or medicinal may be grouped together, as there may be many crossovers and it may be difficult to clearly distinguish between the two groups.
  • Examples of edible and / or medicinal mushrooms useful herein include mushrooms of the genera Agaricus, Agrocybe, Albatrellus, Amanita, Antrodia, Auricularia, Boletus, Calvatia, Cantharellus, Caripia, Clitocybe, Cordyceps, Cyathus, Daldinia, Dictyophora, Elaphomyces, Flammulina, Pomes, Fomitopsis, Funalia, Ganoderma, Geastrum, Grifola, Hericium, Inocybe, Inonotus, Lactarius, Lentinus, Lentinula, Leucop axillus, Lyophyllum, Phellinus, Pholiota, Pleurotus, Poria, Russula, Sarcodona, Schizo
  • Species of particular interest include Agaricus bisporus, A. blazei, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, A. confluens, Amanita muscaria, Antrodia camphorate, Boletus badius, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Caripia Americansi, Clitocybe maxima, Cordyceps cicadicola, C. gunnii, C. liangshanensis, C. militaris, C. pruinose, C.
  • rufus Lentinula edodes, Lentinus edodes, L. polychrous, Lyophyllum decastes, Phellinus linteus, Pholiota nameko, Pleurotus ostreatus, P. pulmonarius, Poria cocos, Schizophyllum commune, Suillus placidus, Trametes versicolor, or Termitomyces albuminosus.
  • edible and/or medicinal mushrooms can be useful in connection with the current disclosure for treating many conditions, directly or indirectly.
  • Reishi mushrooms have been reported to calm the central nervous system and/or have neuroprotective effect, stimulate the immune system, and act as a prebiotic to support gut health.
  • Reishi has been reported to have a beneficial effect on the adrenals, and to be anxiolytic; reducing anxiety and promoting sleep.
  • Reishi has also been associated with improved memory, and sharpened concentration and focus.
  • Lion's Mane reportedly calms mental activity and modulates certain neurotransmitters.
  • “Cannabis” or “Cannabis spp.” as used herein refers to any plant of the genus Cannabis, including plants that may be classified as Cannabis sativa, Cannabis indica, or Cannabis ruderalis. It is well known that despite the foregoing list, some experts believe that there are only 2 species, and still others consider that there is only a single species (generally, C. sativa'). Whatever nomenclature is used, for purposes of this disclosure, “Cannabis” includes all possible members of the genus, without regard to the species to which they are assigned.
  • 'cannabinoids means any of a class of compounds that generally can interact with one or more cannabinoid receptors, including the receptors of the endocannabinoid system, in particular, CB1 and CB2.
  • Cannabinoids include e.g., phytocannabinoids and synthetic cannabinoids.
  • Phytocannabinoids are found in several plant species, especially Cannabis spp. Among the most prevalent and most studied cannabinoids are tetrahydrocannabinol (THC), and cannabidiol (CBD).
  • cannabinoids that have been identified in Cannabis within certain classes including the tetrahydrocannabinols, cannabidiols (including e.g., cannabidol (CBD) and cannabidivarin (CBDV)), cannabigerols, cannabinols, cannabichromenes, and cannabinodiol.
  • CBD cannabidol
  • CBDV cannabidivarin
  • cannabigerols cannabinols
  • cannabichromenes cannabinodiol
  • Other cannabinoids, such as cannabicyclol, cannabieslsoin, and cannabitriol are currently classed as 'miscellaneous' by some researchers.
  • THC is not only a major cannabinoid in Cannabis spp., it is generally the compound responsible for the psychoactive effects of consuming Cannabis.
  • cannabinoids such as cannabinol may also be at least mildly psychoactive.
  • Certain other cannabinoids such as CBD may help regulate or attenuate the psychoactive effects of other cannabinoids.
  • compositions may be created with various ratios of cannabinoids, such as the ratio of CBD to THC or other ratios depending the specific person or the specific condition being treated.
  • Herbal extracts as used herein comprise extracts from one or more of Rehmanniae spp., Achyranthis spp., Corni spp., Moutan spp., Alismatis spp., Dioscorea spp., Plantaginis spp., Hoelen spp., Aconiti spp., Cinnamomi spp., Barosma betulina, Galium aparine, cornsilk from Zea mays, horsetail (Equisetum spp.), resiniferatoxin (or extract from Euphorbia resinifera), capsaicin, saw palmetto, bearberry, cranberry, St. John's Wort, stinging nettle, and/or combinations thereof.
  • nutraceutical compounds that may be useful herein include but are not limited to S-adenosylmethionine, methylfolate, polyphenols, D-mannose, antioxidants, omega-3 fatty acids, or a B vitamin, vitamin A, vitamin C, vitamin D, vitamin E, or a compound providing a biologically-available form thereof, or combinations thereof.
  • curcuminoids means any of the compounds associated with turmeric or curcumin, as derived rhizome of the plant Curcuma longa, or synthetic versions or derivative thereof.
  • Curcuminoids include but are not limited to curcumin (aka diferuloylmethane), analogs of curcumin such as demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC), turmerones, and turmeric oil. Also include are metabolites of curcumin such as tetrahydrocurcumin (THCU), hexahydrocurcumin, and octahydrocurcumin.
  • curcumin aka diferuloylmethane
  • analogs of curcumin such as demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC), turmerones, and turmeric oil.
  • BDMC demethoxycurcumin
  • BDMC bisdemethoxycurcumin
  • turmerones turmerones
  • turmeric oil also include are metabolites of curcumin such as tetrahydrocurcumin (THCU), hexahydrocurcumin, and octahydro
  • Conjugates such as curcumin glucuronide and curcumin sulfate, are also included herein. Conjugation may also provide opportunities for improved delivery of curcumins herein, for example, conjugation to peptide carriers, or polylactic-co-gly colic acid [PLGA]; as well as complexation with essential oils; coadministration with piperine; and encapsulation into nanoparticles, liposomes, phytosomes, polymeric micelles, and cyclodextrins may also be useful herein.
  • curcumins for example, conjugation to peptide carriers, or polylactic-co-gly colic acid [PLGA]; as well as complexation with essential oils; coadministration with piperine; and encapsulation into nanoparticles, liposomes, phytosomes, polymeric micelles, and cyclodextrins may also be useful herein.
  • terpenes means any of the organic compounds commonly known as terpenes or terpenoids. Terpenes are generally aromatic compounds classified as isoprene derivatives. Terpenes suitable for use herein include hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, sesterterpenes, triterpenes, sesquaterpenes, tetraterpenes, polyterpenes, and norisoprenoids.
  • Exemplary terpenes that are particularly useful herein include alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, and valencene.
  • phytol, limonene, humulene, myrcene, cineol, phellandrene, caryophyllene, terpinolene, linalool, ocimene, pinene, or a combination thereof are presently preferred.
  • flavonoids includes any of the class of polyphenolic molecules containing 15 carbon atoms that are naturally produced in plants and are soluble in water. Also included herein as “flavonoids” are natural or synthetic derivative or analogs thereof that have biological activity. Flavonoids of use herein can generally be divided in to 6 groups of structurally related compounds: chaicones, flavones, isoflavonoids, flavanones, anthoxanthins, and anthocyanins. Also useful are flavanols and catechins, as well as glucosides or other derivatives or analogs of any of the foregoing. The flavonoids are found in most fruits and vegetables, particular colorful ones. They are also prevalent in legumes (including soybeans), grains, green and black teas, as well as red wine.
  • Flavonoids have numerous functions in plants, and act as important cell messengers. Various flavonoids are believed to provide healthful benefits and functions to humans such as anti-cancer, anti-inflammatory, anti-allergic, and antioxidant properties. They may also be cardio-protective, cholesterol-lowering, and anti-atherosclerotic. Natural or synthetic flavonoids from any source may be used herein. Generally natural flavonoids are preferred. Flavonoids isolated from Cannabis, such as cannaflavins A, B, and or C, are of interest in certain applications, as are vitexin, isovitexin, apigenin, kaempferol, quercetin, orientin, and luteolin, as well as the catechins found in Cannabis.
  • emulsion means any oil-in-water (O/ W) or water-in-oil (W / O) emulsion, and particular emulsions comprising cannabis extracts and mushroom extract.
  • O/ W oil-in-water
  • W / O water-in-oil
  • the preferred emulsions referenced herein will have an oil phase comprising a Cannabis extract, and a water phase comprising a mushroom extract, herbal extract, or other beneficial component or extract, such as a water-soluble nutraceutical.
  • an emulsion can comprise an oil phase comprising mushroom extract (e.g., one or more lipid- soluble mushroom components), or herbal extracts or lipid-soluble beneficial components or extracts (e.g., lipid-soluble plant extracts or nutraceuticals) with or without cannabis components present.
  • the corresponding water phase for such emulsions can comprise a water phase with a water-soluble extract of cannabis, and/or other water-soluble components.
  • the emulsion is an O/ W or W/O emulsion, and has at least some cannabis extract or component and at least some mushroom, herbal or other nutraceutical component, it is considered an "emulsion" for purposes herein.
  • ranges are provided in shorthand, so as to avoid having to list and describe each and every value within the range. Any appropriate value within the range can be selected, where appropriate, as the upper value, lower value, or the terminus of the range.
  • APM "Apollon Medical” strain of C. sativa
  • CBD cannabidiol
  • CBG cannabigerol
  • 5-HT 5-hydroxytryptamine
  • kHz kilohertz
  • KNN K Nearest Neighbor
  • MCT Medium Chain Triglycerides
  • NK natural killer cells
  • NS AID nonsteroidal anti-inflammatory drugs
  • O/W oil-in-water (emulsion);
  • SFL Sunflower lecithin
  • SVM Support Vector Machines
  • THC tetrahydrocannabinol
  • WPE Whole plant extract
  • W/O water-in-oil (emulsion).
  • compositions generally comprising extracts of Cannabis and edible or medical mushrooms.
  • the compositions are useful for treating multiple conditions.
  • the compositions alternatively or further generally comprise one or more cannabis extracts or purified or partially-purified cannabinoids, in combination with mushroom extracts, herbal extracts, or other components with nutraceutical properties.
  • the compositions are emulsified as O/W or W/O emulsions.
  • the cannabis extracts can be derived from any Cannabis spp., and may include any cannabinoids.
  • the cannabis extracts may further comprise any number of useful terpenes and/or flavonoids.
  • an extract of Cannabis is prepared to maximize one or more lipid-soluble fractions present in the plant, or any portion thereof, such as the buds or other portions that may be useful. Pressing or other mechanical means of removing oils from plants can be used in connection with the compositions herein. Extraction of lipids from Cannabis can be done by any method known in the art. In one embodiment, extraction is preferably done using a solvent that can be readily removed without leaving traces of toxic compounds, such as hexane or other organic solvents. Presently preferred are extraction methods such an ethanolic extraction or supercritical CO 2 extraction.
  • Extraction of Cannabis sativa strains can be from marijuana strains that comprise substantial amounts of the psychoactive cannabinoid, tetrahydrocannabinol ("THC").
  • the extract comprises compounds from one or more of Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains or extracts (e.g., Black Jack, Super Jack, JI, and XJ13), and/or the Lemon family of strains of Cannabis sativa or extracts thereof.
  • the extracts comprise Ringo's Gift, Harle Tsu, ACDC, Charlotte's Web, The Gift, and/or Pineberry strains. Extracts comprising compounds from extracted from proprietary strains that are commercially available from Apollon Formularies, such as "Apollon Medical" (“APM”), are also useful herein. The skilled artisan will appreciate that multiple strains can be extracted for use together.
  • the cannabinoids are derived from hemp strains that comprise less than 0.3% THC by weight.
  • the THC content may be less than 0.2, or even less than 0.1% of the composition.
  • the cannabinoids are derived from marijuana strains but the THC content is reduced or removed from the cannabinoids such that THC is present in the composition at less than about 0.3 percent.
  • the ratio of cannabinoids is set in the compositions.
  • the ratio of CBD to THC ranges from about 1:5 to about 30:1 or more. In other embodiments the ratio may range from about 1:2 to about 10:1. In still other embodiments, the ratio of CBD to THC may be about 1:1 to 5:1. In a presently preferred embodiment, the ratio is about 1:1.
  • the ratio of e.g., CBD to CBG or CBN may be set based on any of a variety of factors, including the health status of the subject being treated, the symptoms of the subject, the condition(s) being treated, and or one or more physiological or genetic criteria.
  • Synthetic cannabinoids may also be useful herein. Certain such synthetic cannabinoids are presently FDA-approved, such as MARINOL, SYNDROS, and CESAMET and can be readily incorporated into the compositions and emulsions.
  • the edible or medicinal mushroom(s) comprise one or more of the species Agaricus blazei, A. bisporus, A. subrufescens, Agrocybe aegerita, A. cylindracea, Albatrellus caeruleoporus, Amanita muscaria, Boletus edulis, Cantharellus cibarius, C. tubaeformis, Cordyceps militaris, C. pruinose, Caripia widelyi, Cyathus africanus, C.
  • the mushroom(s) in other embodiments comprise one or more species such as Albatrellus confluens, Antrodia camphorate, Boletus badius, Clitocybe maxima, Cordyceps sinensis, Cordyceps liangshanensis, Cordyceps gunnii, Cordyceps cicadicola, Pomes fomentarius, Funalia trogii, Hericium erinaceus, Inocybe umbrinella, Lactarius flavidulus, Pleurotus ostreatus, Schizophyllum commune, Suillus placidus, or Trametes versicolor.
  • species such as Albatrellus confluens, Antrodia camphorate, Boletus badius, Clitocybe maxima, Cordyceps sinensis, Cordyceps liangshanensis, Cordyceps gunnii, Cordyceps cicadicola, Pomes fomenta
  • mushrooms are all well known edible and/or medicinal mushrooms with a long history of use. Without limiting the invention to any particular theory of operation, mushrooms, such as Reishi, shitake, maitake, turkey tail, and many others have a plethora of beneficial and potentially therapeutic compounds present in them.
  • the polysaccharides, peptides, and/or other small molecules in various mushrooms have been shown to regulate the production of certain molecular mediators of inflammation and functions of immune cells (e.g., B- and/or T-cells) as well as pro-inflammatory lymphocytes, T-helper cells, T- killer cells, and macrophages.
  • immune cells e.g., B- and/or T-cells
  • the beta-1,3 D-glucans from certain mushrooms and other glycans may suppress cytokines such as interleukins tumor necrosis factor (TNF-a), and still other compounds
  • compositions preferably comprise the benefits of such edible or medicinal mushroom(s) as described above.
  • the edible or medicinal mushrooms or extracts can be present as fresh mushrooms, or as a dried mushroom or extract thereof, a lyophilized mushroom preparation, a mushroom powder, or an aqueous or alcohol extract (e.g., an ethanolic or other alcohol extract) of mushroom. Extracts for purposes herein can include hot- or cold-water extracts. Mushroom concentrates, or partially purified or even extensively purified mushroom fractions, or fully purified components or isolates from a mushroom are also useful herein.
  • various extracts, concentrates, or partially purified fractions, or the like are enriched for one or more advantageous mushroom component, or compounds with desirable effects on treatment of inflammation, immune status, or general health.
  • the extract, concentrate, partially purified fraction, or the like are enriched for one or more phenolic acids, flavonoids, triterpenes, carotenoids, stilbenes, sterols, fatty acids, lignans, chitosan, polyphenols, polysaccharides, glycosides, glucans, polysaccharide-protein complexes, glycoproteins, polysaccharopeptide, krestin, tocopherols, peptides, cyclic peptides, or other amino compounds found in the mushroom.
  • the cannabinoids are derived from Cannabis spp. or an extract thereof.
  • Cannabis can generally be concentrated or extracted (e.g., via mechanical or chemical means) to obtain cannabinoids.
  • Extraction via chemical means includes extraction with various volatile solvents that range from hydrocarbon solvents such as butane, hexanes, or propane, to supercritical fluids, alcohol (e.g., isopropanol, butanol, or ethanol), steam, or even water.
  • Two very common methods are extraction with supercritical carbon dioxide, or ethanol, both of which are particularly useful herein. Extracts can also be distilled to e.g., remove additional compounds of interest, or to concentrate them.
  • Certain components can be removed, e.g., by treatment with steam to strip certain volatiles, which can be captured as an additional component from the Cannabis.
  • compositions include terpenes comprising one or more monoterpenes, one or more sesquiterpenes, or a combination thereof.
  • the terpenes generally comprise one or more of alpha bisabolol, alpha pinene, beta caryophyllene, beta pinene, borneol, camphor, camphene, caryophyllene oxide, cineole, delta-3 carene, eucalyptol, farnesenes, farnesol, fenchol, fenchone, geraniol, guaiol, humulene, isopulegol, limonene, linalool, menthol, myrcene, nerol, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpineol, terpinolene, or valencene.
  • the terpenes comprise phytol, limonene, humulene, myrcene, cineol, phellandrene, caryophyllene, terpinolene, linalool, ocimene, pinene, or a combination thereof.
  • the terpenes preferably comprise one or more of limonene, myrcene, beta-caryophyllene, linalool, alpha pinene, or a combination thereof.
  • the terpenes include beta- ocimene, 1,8-cineole, alpha-pinene and / or beta-pinene, linalool, limonene, phytol, humulene, myrcene, phellandrene, caryophyllene, terpinolene, linalool, or other cineols or ocimenes, or any combination thereof, and the strains used to isolate terpenes are high in those terpenes, relative to other strains.
  • the terpenes are derived from Cannabis spp. or an extract thereof.
  • the terpenes can be derived from any source and in certain embodiments, they can be present in steam distillate or an ethanolic extract of Cannabis sativa.
  • compositions in certain embodiments include extracts of Cannabis spp, such as C. sativa as a source of cannabinoids and/or terpenes.
  • the C. sativa comprises one or more of Ringo's Gift, OG Kush, Strawberry Cough, Orange Cookies, Jack Herer-derived strains, Lemon family strains, Harle Tsu, ACDC, Charlotte's Web, The Gift, or Pineberry strains.
  • the C. sativa comprises the proprietary Apollon Formularies strain, APM.
  • the compositions may further comprise one or more flavonoids.
  • the flavonoids can comprise chaicones, flavones, isoflavonoids, flavanones, anthoxanthins, anthocyanins, flavonols, or glucosides or other biologically active derivatives or analogs thereof, and combinations of any number of the foregoing.
  • flavonoids are included in the compositions are isolated or derived from a plant, mushroom, or other natural source.
  • the composition still further comprises an extract or fraction from one or more traditional Jamaican medicinal plants other than Cannabis spp..
  • Any of the traditional Jamaican or Carribbean medicinal plants may be useful herein.
  • Jamaican plants useful herein include ackee, aloe vera, avocado, breadflower, ginger, leaf of life, sorrel, soursop, tamarind, and trumpet.
  • the traditional medicinal plants comprise Jamaican sorrel (Hibiscus sabdariffa), guinea hen weed (Petiveria alliacea), and/or soursop (Annona murata).
  • the compositions include a whole plant extract, or an extract from any parts or portion thereof including but not limited to leaves (dried, fresh, or extracted), stems, flowers, roots, fruit, seeds, or the like.
  • compositions In terms of compounding the compositions, the skilled artisan will appreciate that methods of maximizing the efficacy of the composition such as by enhancing the bioavailability of one or more components, or by providing the components in optimized ratios, for example one component to another with which it interacts, or each component to the others in ratio(s) that optimize the absorption into the gut or bloodstream, or enhance the therapeutic effect of the composition. The skilled artisan will also understand that some information useful in improving the compounding may be obtained empirically.
  • compositions, or one or more components thereof may be solubilized, micronized, provided as, for example, extracts, powders, lyophilized powders, concentrates, tinctures, essential oils, aqueous or lipid suspensions, emulsions, microemulsions, or in whole or part as liposomal, vesicular, or other delivery systems.
  • extracts, powders, lyophilized powders, concentrates, tinctures, essential oils, aqueous or lipid suspensions, emulsions, microemulsions, or in whole or part as liposomal, vesicular, or other delivery systems As described below, the compounding or formulation of any of the compositions provided herein may be optimized for the intended delivery route.
  • compositions and emulsions in various embodiments may be administered and delivered as pharmaceuticals, however, it is also contemplated that one or more of the compositions may be formulated for administration and delivery by oral routes that include as food and beverages, including solid, semisolid, and liquid foods, such as smoothies, shakes, pudding, broths, teas, and soups.
  • the food and or beverage compositions can also include hot, cold, or even frozen foods (such as frozen desserts).
  • Example 1 An embodiment of a preparation of a Mushroom composition and emulsion in accordance with the specification
  • MCT Medium Chain Triglyceride
  • a mushroom variety, multiple mushroom varieties, or a combination of such mushrooms is selected.
  • the mushroom(s) are dried using a dehydrating process, such as a freeze dryer, low heat, vacuum drying, spray drying, or the like.
  • the dried mushroom(s) are ground to a fine powder, (the size is determined by the formulator, and/or is based on the extraction method selected).
  • Extraction is carried in a single, dual, or multiple step process depending on the fraction sought.
  • Extraction can be via water, alcohol, alcohol/ water mixture, with added salts, buffer, pH control, osmotic conditions, etc., as required.
  • Extraction temperature will generally be controlled but may be hot (e.g., hot water, 40-100 C), cold (e.g., 10 C, 4 C, 0 C, or lower), room temperature, or any temperature that is desired to recover useful components in active form. Any known extraction methods may be used.
  • emulsions can be prepared by sonication.
  • 45 g dried mushroom extract is combined with 90 ml H 2 O and sonicated 6 times for, 10 sec pulses at 25khz.
  • the material is filtered through a filter (e.g., 100 micron filter, 50 micron filter, 10 micron filter); and the filtrate is combined with 10 ml MCT oil, 2.5 ml SFL, and 2.5 ml Tween 80.
  • the mixture is sonicated at 24 khz for six 10 sec pulses.
  • Example 2 An embodiment of a preparation of a Cannabis composition and emulsion in accordance with the specification
  • CBD/CBDV Distillate
  • THC oil distillate
  • CBG isolated
  • MCT Medium Chain Triglyceride
  • the basic Cannabis starting materials are selected e.g., a whole plant, whole plant extract, distillate, isolate depending on desired components.
  • the selected material is subjected to an extraction process for example, whole plants may be steam distilled, alcohol extracted (at any temperature desired, including 'cryogenically' wherein the ethanol or other alcohol cooled to a minimum of -20 C), or extracted via a falling film process, rotovap process, or a wiped film distillation.
  • Supercritical CO 2 processes and other extraction processes may also be used.
  • Isolates may be obtained in a variety of ways depending on the properties of the fractions sought. The skilled artisan will understand how to obtain e.g., isolated cannabinoids such as THC, and/or isolated fractions without THC present. Distillates are obtained via distillation based on extraction of plant material or prior extraction with a solvent that can be distilled off. The desired fraction is left behind as distillate.
  • Emulsions can be prepared by combining cannabinoids with other components and homogenizing and/or sonicating.
  • 15,000 mg of cannabinoids is combined with 10 ml MCT and 2.5 ml SFL.
  • the mixture is warmed to 30 C while stirring 600rpm and the warmed mixture is then homogenized at 5000 rpm for 20 seconds.
  • 45ml H 2 O and 2.5 ml Tween 80 are added before sonicating at 24 kHz for six 10 sec pulses.
  • Example 3 An embodiment of a preparation of a Cannabis - mushroom emulsion in accordance with the specification.
  • THCA oil was used, it was not heated, but instead was mixed overnight in MCT oil/SFL until dissolved.
  • Some cannabis compositions were adjusted by combining 10 g of WPE with 2 g of each CBD, CBG, THC, and THCA, and 2 ml of terpenes.
  • Turkey Tail mushroom extract (45 g) was soaked in 160-proof grain alcohol for 2 hours. The supernate was removed and the alcohol was distilled off. The distillate containing the compounds of interest was mixed with 45 ml water, 10 ml MCT, 2.5 ml SFL, and 2.5ml Tween 80.
  • the resultant emulsion had an average droplet size less than 50, 40 , 30 , or even 20 microns in various embodiments.
  • the emulsion was stable in that it did not readily separate if stored for at least several weeks or longer at 4 C or 25 C.

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Abstract

L'invention concerne des compositions comprenant des extraits de cannabis, ou des cannabinoïdes, et un ou plusieurs champignons ou extraits de champignons comestibles ou médicinaux, en combinaison. L'invention concerne également des émulsions huile dans l'eau et eau dans l'huile comprenant des extraits de cannabis, et au moins un extrait de champignon comestible ou médicinal. L'invention concerne également des procédés de fabrication des compositions et des émulsions.
PCT/IB2021/060080 2020-10-31 2021-11-01 Compositions et émulsions de cannabis Ceased WO2022091051A1 (fr)

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US11905535B2 (en) 2019-10-01 2024-02-20 Empyrean Nueroscience, Inc. Genetic engineering of fungi to modulate tryptamine expression
US11998515B1 (en) 2023-04-24 2024-06-04 King Faisal University Enhancement of curcumin plasma levels using eucalyptol co-administration
US12104179B2 (en) 2021-12-31 2024-10-01 Empyrean Neuroscience, Inc. Genetically modified organisms for producing psychotropic alkaloids

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WO2020024056A1 (fr) * 2018-08-01 2020-02-06 Lazar Eve Compositions comprenant des cannabinoïdes et matériau absorbable et utilisations associées
WO2020188577A1 (fr) * 2019-03-21 2020-09-24 Alvit Lcs Pharma Ltd. Association de doses fixes de cannabinoïdes et de champignons médicinaux pour la prévention et le traitement du cancer, de maladies inflammatoires ou inflammatoires à médiation immunitaire

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WO2020024056A1 (fr) * 2018-08-01 2020-02-06 Lazar Eve Compositions comprenant des cannabinoïdes et matériau absorbable et utilisations associées
WO2020188577A1 (fr) * 2019-03-21 2020-09-24 Alvit Lcs Pharma Ltd. Association de doses fixes de cannabinoïdes et de champignons médicinaux pour la prévention et le traitement du cancer, de maladies inflammatoires ou inflammatoires à médiation immunitaire

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11905535B2 (en) 2019-10-01 2024-02-20 Empyrean Nueroscience, Inc. Genetic engineering of fungi to modulate tryptamine expression
US12104179B2 (en) 2021-12-31 2024-10-01 Empyrean Neuroscience, Inc. Genetically modified organisms for producing psychotropic alkaloids
US11998515B1 (en) 2023-04-24 2024-06-04 King Faisal University Enhancement of curcumin plasma levels using eucalyptol co-administration

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