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WO2019036243A1 - Formulations - Google Patents

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Publication number
WO2019036243A1
WO2019036243A1 PCT/US2018/045714 US2018045714W WO2019036243A1 WO 2019036243 A1 WO2019036243 A1 WO 2019036243A1 US 2018045714 W US2018045714 W US 2018045714W WO 2019036243 A1 WO2019036243 A1 WO 2019036243A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
cannabinoid
thc
surfactant
polysorbate
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/US2018/045714
Other languages
English (en)
Inventor
Tuna Yucel
Scott S. FINNANCE
Stephen E. Zale
Nicholas J. BOYLAN
William Stephen Faraci
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Molecular Infusions LLC
Original Assignee
Molecular Infusions LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from PCT/US2018/018382 external-priority patent/WO2018152334A1/fr
Application filed by Molecular Infusions LLC filed Critical Molecular Infusions LLC
Publication of WO2019036243A1 publication Critical patent/WO2019036243A1/fr
Priority to US16/789,869 priority Critical patent/US20200246404A1/en
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
    • 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
    • A61K31/658—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • 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
    • 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
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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)
    • 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

Definitions

  • compositions comprising one or more or at least two active ingredient(s), e.g., a cannabinoid, cannabinoid extract, terpene, or terpene
  • the invention further provides for compositions comprising a surfactant and/or co ⁇ solvent, as well as methods of making and using the same.
  • the compositions include self ⁇ emulsifying formulations and formulations that form micelle solution/dispersions.
  • the compositions of the present invention are suitable for oral administration.
  • the compositions increase drug solubilization through colloidal or micellar dispersion.
  • the compositions may reduce the time of onset, effect of food on absorption, and potentially lower hepatic first ⁇ pass metabolism of the cannabinoid, thereby improving bioavailability.
  • Cannabinoids are a class of active compounds derived from the Cannabis sativa, Cannabis indica, or Cannabis hybrid plant commonly known as marijuana.
  • the most notable cannabinoid is the phytocannabinoid tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis.
  • THC phytocannabinoid tetrahydrocannabinol
  • tetrahydrocannabinol ( ⁇ 8 ⁇ THC) mimic the actions of anandamide and 2 ⁇
  • arachidonoylglycerol neurotransmitters produced naturally in the body. These cannabinoids produce the effects associated with cannabis by binding to the CB1 cannabinoid receptors in the brain.
  • Cannabidiol is another major constituent of the cannabis plant.
  • Other cannabinoids include Cannabigerol (CBG), Cannabichromene (CBC), Cannabicyclol (CBL), Cannabivarin (CBV), Tetrahydrocannabivarin (THCV), Cannabidivarin (CBDV),
  • Cannabichromevarin CBCV
  • Cannabigerovarin CBGV
  • Cannabigerol Monomethyl Ether CBGM
  • Tetrahydrocannabinolic acid THCA
  • cannabinol CBN
  • Cannabidiolic Acid CBDA
  • MARINOL® Synthetic ⁇ 9 ⁇ tetrahydrocannabinol (dronabinol) is marketed under the trade name MARINOL®.
  • Dronabinol is approved by the Food and Drug Administration (FDA) for the control of nausea and vomiting associated with chemotherapy and for appetite stimulation of AIDS patients suffering from the wasting syndrome.
  • MARINOL® is a formulation of dronabinol in sesame oil presented as a soft gelatin capsule for oral administration. After oral administration, dronabinol has an onset of action of approximately 0.5 to 1 hours and peak effect at 2 to 4 hours. Duration of action for psychoactive effects is 4 to 6 hours, but the appetite stimulant effect of dronabinol may continue for 24 hours or longer after administration.
  • Dronabinol is almost completely absorbed (90 to 95%) after single oral doses. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic circulation.
  • compositions for treating pain, inflammation and inflammatory diseases including autoimmune inflammatory diseases such as MS, and other diseases, conditions, and pathologies.
  • composition comprising a lipophilic agent that disperses rapidly in aqueous medium and forms a transparent emulsion or micellar dispersion.
  • the present invention addresses these needs by providing improved formulations, including rapid dispersing formulations, for use in a variety of conditions including pain, inflammation and
  • autoimmune inflammatory diseases including autoimmune inflammatory diseases such as MS, nausea and vomiting, and other diseases or conditions.
  • a first aspect provides a composition comprising:
  • the composition comprises at least two active ingredients. In one embodiment, at least one of the active ingredients is a cannabis extract.
  • At least one of the active ingredients is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises at least two active ingredients selected from: one or more cannabinoids and/or one or more terpenes and/or one or more other active ingredients selected from ethyl pyruvate, melatonin, caffeine or resveratrol.
  • the composition comprises at least one active ingredient; and at least one surfactant.
  • At least one of the active ingredients is a cannabis extract.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises more than one active ingredient and/or more than surfactant.
  • composition further comprises a co ⁇ solvent.
  • composition comprises:
  • At least one fatty acid at least one monoglyceride, at least one diglyceride, or at least one triglyceride, or a combination thereof.
  • At least one of the active ingredients is a cannabis extract.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises more than one active ingredient.
  • the composition comprises more than one surfactant.
  • the composition comprises more than one fatty acid, more than one monoglyceride, more than one diglyceride, more than one triglyceride, or a combination thereof.
  • the composition further comprises a co ⁇ solvent.
  • the composition is a non ⁇ aqueous formulation.
  • the composition is a pharmaceutical composition, preferably an oral dosage form.
  • the oral dosage form is a solid, liquid, or semi ⁇ solid oral dosage form.
  • the invention provides for a unit dose of the composition.
  • a second aspect provides a method of making the composition of the first aspect or otherwise of the present invention, comprising the steps of:
  • At least one fatty acid optionally, providing at least one fatty acid, at least one monoglyceride, at least one diglyceride, or at least one triglyceride, or a combination thereof;
  • the method comprises providing more than one active ingredient. In another embodiment, the method comprises providing more than one
  • the method comprises providing more than one fatty acid, more than one monoglyceride, more than one diglyceride, and/or more than one triglyceride. In another embodiment, the method comprises providing a co ⁇ solvent.
  • At least one of the active ingredients is a cannabis extract.
  • the active ingredient is selected from a cannabinoid,
  • cannabinoid extract cannabinoid extract, terpene, or terpene extract.
  • a third aspect provides for a method of treating or preventing a disease or condition in a subject, e.g., human, including pain, nausea, and/or vomiting, autoimmune
  • inflammatory diseases such as MS, and other diseases and conditions, comprising the step of administering to said subject an effective amount of a composition of the first aspect.
  • the composition is a non ⁇ aqueous composition. In another embodiment, the composition is free of fats or oils. In another embodiment, the
  • composition is free of exogenously added fatty acids, monoglycerides, diglycerides, or triglycerides (e.g., MCT or LCT).
  • the composition is a
  • the pharmaceutical composition comprises a physiologically/pharmaceutically acceptable excipient.
  • the composition is a rapid dispersing formulation, forming a transparent emulsion or micellar dispersion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a final concentration of 0.1 wt% (composition) and at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C.
  • the rapid dispersing formulation does not require agitation (e.g., shaking or stirring) for emulsification/dispersion.
  • the composition is a unit dose.
  • the composition is an oral dosage form, or more preferably, a solid, liquid, or semi ⁇ solid, non ⁇ aqueous, oral dosage form.
  • Emulsion particle size as a function of HLB number.
  • Formulation surfactant content 50 vol.% and aqueous emulsion concentration of 1.0 vol.%.
  • Open and solid circles denote Polysorbate – Span 80 blends and pure polysorbates, respectively.
  • Formulation surfactant content for squares, triangles and x symbols were 50, 75 and 90 vol.%, respectively.
  • Formulation surfactant content for squares, triangles and x symbols were 50, 75 and 90 vol.%, respectively.
  • Figure 9 Minimum mass ratio of PEG ⁇ 40 hydrogenated castor oil to THC ⁇ distillate as a function of artificial orange flavor concentration in some beverage additive compositions that rapidly self ⁇ emulsify into micellar dispersions when added to water or another
  • composition of the present invention “comprising an active
  • ingredient contains one or any number of active ingredients, unless otherwise specified.
  • the phrases “consists of” or “consisting of” are closed ⁇ ended and includes only those features specified. When used in a clause, the phrases “consists of” or “consisting of” limit only the element set forth in that clause.
  • phrases "consists essentially of” and “consisting essentially of” are partially open and limited to features that do not materially affect the basic and novel characteristic(s)" of the claimed invention.
  • the phrases include an unrecited level of impurities that do not materially affect the basic and novel characteristic(s), e.g., activity or stability, of a composition of the invention.
  • treat means to alleviate, reduce or abrogate one or more symptoms or characteristics of a disease or disorder and may be curative, palliative, prophylactic or slow the progression of the disease or disorder.
  • an amount of active ingredient(s) means an amount of active ingredient(s) that will result in a desired effect or result.
  • therapeutically effective amount means an amount of active ingredient(s) that will elicit a desired biological or pharmacological response, e.g., effective to prevent, alleviate, or ameliorate symptoms of a disease or disorder; slow, halt or reverse an underlying process or progression of a disease or disorder; partially or fully restore cellular function; or prolong the survival of the subject being treated.
  • patient or subject means an animal, including mammals, non ⁇ human animals, and especially humans.
  • the patient or subject is a human.
  • the patient or subject is a human male.
  • the patient or subject is a human female.
  • compositions comprising a at least one active ingredient.
  • the composition comprises at least two active ingredients.
  • at least one of the active ingredients is a cannabinoid, cannabinoid extract, or cannabis extract.
  • the composition further comprises a surfactant.
  • the compositions further comprise a co ⁇ solvent.
  • the composition is a rapid dispersion formulation.
  • compositions include self ⁇ emulsifying compositions, e.g., self ⁇ emulsifying drug delivery systems (SEDDS), oil ⁇ free, and micellar dispersions, comprising an active ingredient, e.g., cannabinoid.
  • Some of the compositions comprise at least one co ⁇ solvent.
  • Some of the compositions comprise at least one fatty acid, at least one monoglyceride, at least one diglyceride, at least one triglyceride, or a combination thereof.
  • compositions that comprise a triglyceride include compositions that comprise a medium chain triglyceride (MCT) or a long chain triglyceride (LCT), wherein the MCT and LCT, unless otherwise specified, represents either a single species of medium chain triglyceride or long chain triglyceride, respectively, or a mixture of medium chain triglycerides and/or long chain
  • MCT medium chain triglyceride
  • LCT long chain triglyceride
  • compositions including self ⁇ emulsifying drug delivery systems (SEDDS) and micelles, (e.g., swollen micellar dispersions), of the present invention enhance oral bioavailability by the formation of colloidal dispersions, thus increasing solubility of the active ingredient.
  • SEDDS self ⁇ emulsifying drug delivery systems
  • micelles e.g., swollen micellar dispersions
  • the composition is a non ⁇ aqueous composition. In another embodiment, the composition is free of fats or oils. In another embodiment, the
  • composition is free of exogenously added fatty acids, monoglycerides, diglycerides, or triglycerides (e.g., MCT or LCT).
  • the composition has a viscosity of less than or equal to: 100, 90, 80, 70, 60, 50, 45, 40, 35, 30, 25, 20, 17.5, 15, 12.5, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.5 cP at 20 degrees C.
  • the composition is a rapid dispersing formulation, forming a transparent emulsion or micellar dispersion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium, e.g., water or deionized water, at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • the rapid dispersing formulation does not require agitation (e.g., shaking or stirring) for
  • the composition is a unit dose.
  • the composition is an oral dosage form, or more preferably, a solid, liquid, or semi ⁇ solid, non ⁇ aqueous, oral dosage form.
  • composition is a pharmaceutical composition.
  • pharmaceutical composition comprises a
  • compositions of the present invention include formulations that avoid hepatic first ⁇ pass metabolism, in part, by targeting chylomicron/lipoprotein delivery.
  • compositions of the present invention include formulations that have a faster onset of action – the time it takes an active ingredient to reach a minimum effective concentration after the active ingredient is administered.
  • the compositions of the present invention include formulations that have greater stability, greater oral bioavailability, or reduced individual variability of bioavailability, e.g., by reducing food ⁇ effect, greater efficacy, or, in the case of THC, a more intense psychotropic effect as compared to MARINOL®. and may be formulated for immediate release.
  • compositions of the present invention comprise at least one active ingredient.
  • at least one of the active ingredients is a cannabis extract.
  • at least one of the active ingredients is selected from a cannabinoid,
  • cannabinoid extract cannabinoid extract, terpene, or terpene extract.
  • the composition comprises at least two active ingredients.
  • at least one of the active ingredients is selected from one or more cannabis extract, cannabinoid, cannabinoid extract, terpene, or terpene extract, or
  • At least one of the active ingredients is selected from one or more anti ⁇ insomnia, anti ⁇ tussive, opioid analgesic, decongestant, non ⁇ opioid analgesic/anti ⁇ inflammatory drug, anti ⁇ migraine drug, anti ⁇ emetic, anti ⁇ histamine, proton pump inhibitor,
  • H 2 antagonist/H 2 blocker tranquilizer, anticonvulsant, hypnotic, muscle relaxant, anti ⁇ psychotic, anti ⁇ diarrheal, Attention Deficit and Hyperactivity Disorder (ADHD) drug, anti ⁇ Parkinson disease drug, benzodiazepine, benzodiazepine antagonist, barbiturate, barbiturate antagonist, stimulant, stimulant antagonist, antidepressant, nutraceutical, nicotine, BCS Class II active ingredient, BCS Class IV active ingredient, an anti ⁇ multiple
  • ADHD Attention Deficit and Hyperactivity Disorder
  • MS sclerosis
  • the composition comprises:
  • the active ingredient(s) comprise an anti ⁇ insomnia.
  • the anti ⁇ insomnia is selected from any one or more of: melatonin, L ⁇
  • the active ingredient(s) comprise an anti ⁇ tussive.
  • the anti ⁇ tussive is selected from any one or more of: benzonatate, caramiphen edisylate, chlophedianol, codeine, dextromethorphan hydrobromide, hydrocodone, levopropoxyphene, morphine, codeine, ethylmorphine, dihydrocodeine, benzylmorphine, laudanum, dihydroisocodeine, nicocodeine, nicodicodeine, hydrocodone, hydromorphone, acetyldihydrocodeine, thebacon, diamorphine (heroin), acetylmorphone, noscapine, or pholcodine.
  • the active ingredient(s) comprise an opioid analgesic.
  • the opioid analgesic is selected from any one or more of: alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine,
  • diampromide diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol,
  • dimepheptanol dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl,
  • hydrocodone hydromorphone, hydroxypethidine, isomethadone, ketobemidone,
  • methadone metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpipanone, opium, oxycodone,
  • oxymorphone papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, proheptazine, promedol, properidine, propiram, propoxyphene, sufentanil, tilidine, or tramadol.
  • the active ingredient(s) comprise a decongestant.
  • the decongestant is selected from any one or more of: pseudoephedrine hydrochloride, phenylephrine bitartrate, phenylephrine hydrochloride or pseudoephedrine sulfate.
  • the active ingredient(s) comprise a non ⁇ opioid analgesic/anti ⁇ inflammatory drug.
  • the non ⁇ opioid analgesic/ anti ⁇ inflammatory is selected from any one or more of: acetaminophen or a non ⁇ steroidal anti ⁇ inflammatory agent selected from the group consisting of aspirin, celecoxib, ibuprofen, diclofenac, naproxen, benoxaprofen, flurbiprofen, fenoprofen, flubufen, ketoprofen, indoprofen, piroprofen, carprofen, oxaprozin, pramoprofen, muroprofen, trioxaprofen, suprofen, aminoprofen, tiaprofenic acid, fluprofen, bucloxic acid, indomethacin, sulindac, tolmetin, zomepirac, tiopinac, zidometacin
  • the active ingredient(s) comprise an anti ⁇ migraine drug.
  • the anti ⁇ migraine drug is selected from any one or more of: 2 ⁇ bromo ⁇ LSD, acetaminophen/dichloralphenazone/isometheptene mucate, almotriptin, alniditan, amidrine, avitriptan, caffeine/ergotamine, calcitonin gene ⁇ related peptide receptor antagonist, clonidine, dasolampanel, dihydroergotamine, dimetotiazine, donitriptan, dotarizine, eletriptan, ergotamine, ergotamine/chlorcyclizine/caffeine, flumedroxone acetate, iprazochrome, lasmiditan, lisuride, lomerizine, methysergide, migraleve,
  • paracetamol/metoclopramide paracetamol/metoclopramide, prochlorperazine, promethazine, proxibarbital, rimegepant, rizatriptan, selurampanel, sumatriptan, telcagepant, tezampanel, topiramate, or zolmitriptan.
  • the active ingredient(s) comprise an anti ⁇ emetic.
  • the anti ⁇ emetic is selected from any one or more of: dolasetron, granisetron, ondansetron, tropisetron, palonosetron, mirtazapine, metoclopramide, cyclizine, diphenhydramine, dimenhydrinate, meclizine, promethazine, or hydroxyzine.
  • the active ingredient(s) comprise an anti ⁇ histamine.
  • the anti ⁇ histamine is selected from any one or more of: diphenhydramine, loratadine, desloratadine, meclizine, fexofenadine, pheniramine, cetirizine, promethazine, brompheniramine, clemastine fumarate or chlorpheniramine.
  • the active ingredient(s) comprise a proton pump inhibitors (PPI).
  • PPI proton pump inhibitors
  • the PPI is selected from any one or more of: omeprazole, esomeprazole, pantoprazole, lansoprazole, or rabeprazole.
  • the active ingredient(s) comprise a H 2 antagonist/H 2 blocker.
  • the H 2 antagonist/H 2 blocker is selected from any one or more of: cimetidine, ranitidine, or famotidine, nizatidine, ebrotidine, mifentidine, roxatidine, pisatidine, or aceroxatidine.
  • the active ingredient(s) comprise a tranquilizer.
  • the tranquilizer is selected from any one or more of: amobarbital,
  • the active ingredient(s) comprise an anticonvulsant.
  • the anti ⁇ convulsant is selected from any one or more of: elbamate,
  • the active ingredient(s) comprise a hypnotic.
  • the hypnotic is selected from any one or more of: zolpidem, zaleplon, zopiclone, or eszopiclone.
  • the active ingredient(s) comprise a muscle relaxant.
  • the muscle relaxant is selected from any one or more of: methocarbamol, carisoprodol, chlorzoxazone, cyclobenzaprine, gabapentin, metaxalone, or orphenadrine.
  • the active ingredient(s) comprise an anti ⁇ psychotic.
  • the anti ⁇ psychotic is selected from any one or more of: haloperidol,
  • methotrimeprazine pimozide, chlorprothixene, flupenthixol, thiothixene, zuclopenthixol, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, amisulpride, asenapine, or paliperidone.
  • the active ingredient(s) comprise an anti ⁇ diarrheal.
  • the anti ⁇ diarrheal is bismuth subsalicylate or loperamide.
  • the active ingredient(s) comprise an Attention Deficit and Hyperactivity Disorder (ADHD) drug.
  • ADHD drug is selected from any one or more of: methylphenidate, dextroamphetamine sulfate, amphetamine, or atomoxetine hydrochloride.
  • the active ingredient(s) comprise an anti ⁇ Parkinson disease drug.
  • the anti ⁇ Parkinson disease drug is selected from any one or more of: amantadine, Apokyn, apomorphine, bromocriptine, carbidopa/levodopa, Cycloset, Duopa, entacapone/levodopa/carbidopa, Gocovri, levodopa, Mirapex, Mirapex ER, Neupro, Parlodel, pramipexole, Requip, Requip XL, ropinirole, rotigotine, Rytary, Sinemet, Sinemet CR, or Stalevo.
  • the active ingredient(s) comprise a benzodiazepine.
  • the benzodiazepine is selected from any one or more of: alprazolam, bromazepam, chlordiazepoxide, clorazepate, diazepam, estazolam, flurazepam, halazepam, ketazolam, lorazepam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.
  • the active ingredient(s) comprise is a benzodiazepine antagonist.
  • the benzodiazepine antagonist is flumazenil.
  • the active ingredient(s) comprise a barbiturate.
  • the barbiturate is selected from any one or more of: amobarbital,
  • the active ingredient(s) comprise a barbiturate antagonist.
  • the barbiturate is an amphetamine.
  • the active ingredient(s) comprise a stimulant.
  • the stimulant is selected from caffeine or an amphetamine, such as amphetamine, dextroamphetamine resin complex, dextroamphetamine, and
  • the active ingredient(s) comprise a stimulant antagonist.
  • the stimulant antagonist is a benzodiazepine.
  • the active ingredient(s) comprise an antidepressant.
  • the antidepressant is selected from any one or more of: agomelatine, Allegron (see nortriptyline), amitriptyline, Anafranil (see clomipramine), Brintellix (see vortioxetine), Cipralex (see escitalopram), Cipramil (see citalopram), citalopram,
  • clomipramine Cymbalta (see duloxetine), Depefex XL (see venlafaxine), dosulepin, doxepin, duloxetine, Edronax (see reboxetine), Efexor XL (see venlafaxine), escitalopram, Faverin (see fluvoxamine), fluoxetine, fluvoxamine, Foraven XL (see venlafaxine), imipramine, isocarboxazid, lofepramine, Lomont (see lofepramine), Lustral (see sertraline), Manerix (see moclobemide), mianserin, mirtazapine, moclobemide, Molipaxin (see trazodone), Nardil (see phenelzine), nortriptyline, Oxactin (see fluoxetine), Parnate (see tranylcypromine), paroxetine, phenelzine, Politid XL (see
  • fluoxetine Prozep
  • reboxetine Seroxat
  • sertraline Sinepin (see doxepin)
  • Sunveniz XL see venlafaxine
  • Surmontil see trimipramine
  • Tofranil see imipramine
  • Tonpular XL see venlafaxine
  • tranylcypromine tranylcypromine
  • trazodone trimipramine
  • Triptafen Triptafen
  • Valdoxan see agomelatine
  • Venadex XL see venlafaxine
  • Venaxx XL see venlafaxine
  • venlafaxine Venlalic XL (see venlafaxine)
  • ViePax see venlafaxine
  • the antidepressant is selected from any one or more of: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), milnacipran (Ixel, Savella), venlafaxine (Effexor), reboxetine (Edronax), teniloxazine (Lucelan, Metatone), or viloxazine (Vivalan).
  • the active ingredient(s) comprise a nutraceutical.
  • the nutraceutical is selected from any one or more of: 5 ⁇
  • methyltetrahydrofolic acid ademetionine, adenine, adenosine monophosphate, alfacalcidol, alpha ⁇ linolenic acid, ATP, beta carotene, biotin, calcidiol, calcitriol, castor oil, cholecalciferol, choline, chondroitin sulfate, coenzyme A, coenzyme Q10, creatine, curcumin,
  • cyanocobalamin cystine, dihomo ⁇ gamma ⁇ linolenic acid, ephedra, ergocalciferol, eucalyptol, fish oil, folic acid, ginkgo biloba, ginkgolide ⁇ A, ginkgolide ⁇ B, ginkgolide ⁇ C, ginkgolide ⁇ J, ginkgolide ⁇ M, ginseng, ginsenoside C, ginsenoside Rb1, ginsenoside Rg1, glutamic acid, glutathione, glycine, glycine betaine, histidine, hyperforin, icosapent, icosapent ethyl, inulin, kava, krill oil, L ⁇ Alanine, L ⁇ Arginine, L ⁇ Asparagine, L ⁇ Aspartic Acid, L ⁇ Citrulline, L ⁇ Cysteine, L ⁇ Glutamine, L ⁇ Isoleucine, L ⁇ Leucine, L
  • riboflavin sage oil, serine, serotonin, sesame oil, sinecatechins, spermine, St. John's Wort, succinic acid, taurine, tetrahydrofolic acid, thiamine, tretinoin, tyramine, ubidecarenone, ubiquinol, vitamin A, vitamin C, vitamin D, vitamin E, or vitamin K.
  • one or more active ingredients may be selected from the following ingredients based on indication, classification, or site of action:
  • Skin health/beauty calcium, chromium, selenium, zinc, ascobyl pulminate, magnesium, L ⁇ carnitine, N ⁇ acetyL ⁇ L ⁇ carnitine, L ⁇ glutamine, collagen hydrolysate, tumeric, dmae (dimethylaminoethanol), green tea, grape seed, alpha lipoic acid, aloe vera extract, coenzymeq10, walnut, pomegranate, botanical gelatin, polyphenols, flavonoids;
  • CNS and brain function Vinpocetine, Ginkgo Biloba, L ⁇ Arginine, Acetyl ⁇ L ⁇ Carnitine, Feverfew, DMAE (Dimethylaminoethanol), DMAE bitartrate, P ⁇ chlorophenoxyacetate;
  • Bone coral calcium, magnesium, Vitamin K, boron
  • Digestive tarragon oil, amylase, proteases, lipase, cellulose, pectin, HCL, sucrase, maltase, lactase, probiotics;
  • Vitamin B ⁇ complex Vitamin B ⁇ complex, ginseng, ginkgo biloba, caffeine, theobromine; Hormone: DHEA (Dehydroepiandrosterone), pregnenolone, melatonin;
  • Weight Loss Hoodia gordonii, Gymnema sylvestre, hydroxycitrate: green tea leaf extract, betaine, piperine, potassium, maltodextrin, Vitamin C, Vitamin E, thiamin,
  • riboflavin riboflavin, niacinamide, pyridoxine hydrochloride, biotin, chromium, molybdenum, Garcinia Cambogia, Congugated Linoleic Acid (CLA), Glucosol, Guarana, Hawthorn, ECGC
  • Prostate nettle root, saw palmetto, pygeum, lysopene;
  • MSM dimethylsulfone
  • glucosamine chondroitin
  • Liver Detox N ⁇ Acetyl Cystene, Milk, Thistle, Green Tea, Alpha Lipoic Acid, Red Clover,
  • Multi ⁇ Vitamin Vitamins A, C, D3, E, B1, B2, B3, B6, B12, folic acid pantothenic acid, biotin, calcium, iodine, magnesium, zinc, selenium, manganese, chromium, molybdenum, potassium, inositol;
  • Immune green tea extract, colostrum, indole 3 carbonal, shitake mushroom, grapefruit seed extract, beta 1 ⁇ 3 glucon;
  • Female Libido pantothenic acid, L ⁇ arginine, muira puama, maca root, avena sativa, dong quai, choline, ginkgo biloba;
  • Post Memopausal black cohash, dong quai, chastertree berry, green tea, red clover, indole 3 carbinol;
  • Body Building Androstenedione, L ⁇ glutamine, L ⁇ tyrosine, L ⁇ arginine, L ⁇ glycine, L ⁇ lysine, whey protein, DHEA (Dehydroepiandrosterone);
  • Antioxidant Vitamin C, Vitamin E, grape seed, alpha lipoic acid, green tea; Hangover: pharmaceutical charcoal, calcium.
  • the nutraceutical is selected from the group consisting of: folic acid, B ⁇ 6, K ⁇ 1, Co ⁇ Q, green tea, echinacea, myrrh or other medicinal oils, and derivatives of seaweed or kelp.
  • the nutraceuticals is selected from the group consisting of: vitamins, minerals, trace minerals, amino acids, antioxidants, alpha lipoic acid, CoQ10, DMAE, SAMe, phospholipids, choline, triglycerides, and hormones such as
  • the nutraceutical is a plants or plant component selected from the group consisting of: garlic, ginkgo biloba, kava kava, noni, ginseng, saw palmetto, milk thistle, stinging nettle, eucalyptus, aloe vera, feverfew, nasturtium, Ma Huang, and echinacea.
  • the active ingredient(s) comprise nicotine.
  • the active ingredient(s) comprise a BCS Class II active
  • the BCS Class II active ingredient is selected from any one or more of following: aceclofenac, albendazole, amiodarone, atorvastatin, azithromycin, bicalutamide, bisacodyl, cabergoline, candesartancilexetil, carbamazepine, carvedilol, cefditoren, celecoxib, chloroquine, chlorpromazine, cilostazol, ciprofloxacin, cisapride, clarithromycin, clofazimine, clopidogrel, clozapine, cyclosporine, cyproterone, danazol, dapsone, diazepam, diclofenac, diflunisal, digoxin, diloxanide, ebastine, efavirenz, epalrestat, eprosartan, erythromycin, ethylicosapentate, ezetimi
  • At least one active ingredient is a BCS Class IV active ingredient.
  • the BCS Class IV active ingredient is selected from any
  • acetaminophen paracetamol
  • acetazolamide paracetamol
  • acetylsalicylic acid acyclovir
  • allopurinol aluminium hydroxide, amoxicillin, azathioprine, cefdinir, cefixime, cefotiam, cefpodoxime, cefuroxime axetil, dapsone, dexamethasone, doxycycline, famotidine, folic acid, hydrochlorothiazide, L ⁇ carbocysteine, levodopa, linezolid,
  • At least one active ingredient is ethyl pyruvate.
  • Ethyl pyruvate is a redox analogue of dimethyl fumarate (Tecfidera), a drug for treating multiple sclerosis treatment.
  • Ethyl pyruvate efficiently suppressed the release of MS signature cytokines, IFN ⁇ ⁇ and IL ⁇ 17, from human PBMCs in vitro and from encephalitogenic T cells after in vivo application of EP to rats.
  • MS signature cytokines IFN ⁇ ⁇ and IL ⁇ 17
  • Djordje Miljkovi ⁇ et al. J Immunol 194 (6) 2493 ⁇ 2503 (2015).
  • Ethyl pyruvate has also been described for use in treating reperfusion injury (WO01/24793), some inflammatory disorders (WO02/074301, US2003/0232884), and renal failure
  • the active ingredient(s) is selected from one or more of group consisting of: ace ⁇ inhibitors, anti ⁇ Alzheimer's agents, antianginal drugs, anti ⁇ arrhythmias, anti ⁇ asthmatics, anti ⁇ cholesterolemics, analgesics, anesthetics, anti ⁇
  • convulsants anti ⁇ depressants, anti ⁇ diabetic agents, anti ⁇ diarrhea preparations, antidotes, anti ⁇ emetics, anti ⁇ histamines, anti ⁇ hypertensive drugs, anti ⁇ inflammatory agents, anti ⁇ lipid agents, anti ⁇ manics, anti ⁇ migraines, anti ⁇ nauseants, anti ⁇ stroke agents, anti ⁇ thyroid preparations, anti ⁇ tumor drugs, anti ⁇ viral agents, acne drugs, alkaloids, amino acid preparations, anti ⁇ tussives, anti ⁇ uricemic drugs, anti ⁇ viral drugs, anabolic preparations, systemic and non ⁇ systemic anti ⁇ infective agents, anti ⁇ neoplastics, anti ⁇ parkinsonian agents, anti ⁇ rheumatic agents, anxiolytics, anti ⁇ psychotics, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, bronchodilators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants,
  • hypocalcemia management agents immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, non ⁇ steroidal anti ⁇
  • NSAID inflammatories
  • obesity management agents include obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, serotonin 5 ⁇ HT3 receptor antagonists, smoking
  • cessation aids sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti ⁇ pyretics, appetite suppressants, expectorants, anti ⁇ anxiety agents, anti ⁇ ulcer agents, anti ⁇ inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho ⁇ tropics, stimulants, anti ⁇ hypertensive
  • drugs vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti ⁇ psychotics, anti ⁇ tumor drugs, anti ⁇ coagulants, anti ⁇ thrombotic drugs, hypnotics, anti ⁇ emetics, anti ⁇ nauseants, anti ⁇ convulsants, neuromuscular drugs, hyper ⁇ and hypo ⁇ glycemic agents, thyroid and anti ⁇ thyroid preparations, diuretics, anti ⁇ spasmodics, anti ⁇ obesity drugs, erythropoietic drugs, anti ⁇ asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.
  • the active ingredient is selected from one or more of the following: acetylcholine agonists, acromegaly agents, AIDS/HIV adjunct agents, alcohol dependence preparations, amyotrophic lateral sclerosis therapeutic agents, acetaminophen, centrally acting analgesic, narcotics, narcotic agonist ⁇ antagonist, narcotics, nonsteroidal anti ⁇ inflammatory drugs (NSAIDS), salicylates, aspirin, general anaesthetics, local
  • anaesthetics including anaesthetics, anticonvulsants barbiturates, benzodiazepines, Gaba analogues, hydantoins, anticonvulsants, phenyltriazines, antidiabetic agents (including biguanides , glucosidase inhibitors, insulins intermediate acting insulins, intermediate and rapid acting insulin, long acting insulins, rapid acting insulins, meglitinides, sulfonylureas, or thiazolidinediones), acetaminophen antagonists, antivenins, benzodiazepine antagonists, chelating agents, digoxin antagonists, antifibrosis therapy, antihistamines, anti ⁇ infective agents, aids adjunct anti ⁇ infectives (including non ⁇ nucleoside reverse transcriptase inhibitors nucleoside reverse transcriptase inhibitors, nucleotide analogue reverse transcriptase inhibitors or protease inhibitors), anthelmintics
  • G ⁇ CSF granulocyte
  • GM ⁇ CSF granulocyte macrophage
  • hematinics erythropoiesis stimulants
  • folic acid derivatives & iron hemostatics, systemic hemostatics, plasma fractions, human albumin, antihemophilic factor, anti ⁇ inhibitor coagulant complex, antithrombin III, factor IX complex, immune globulin, plasma protein fraction, selective factor XA inhibitor, thrombin inhibitors, thrombolytic agents, vitamin K, bone metabolism regulators, cardioprotective agents, adrenergic blockers, peripheral & adrenergic stimulants, central & alpha/beta adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin converting enzyme (ACE) inhibitors with calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors with diuretics, angiotensin II receptor antagonists,
  • ACE angiotensin converting enzyme
  • ACE
  • angiotensin II receptor antagonists with diuretics group I antiarrhythmics, antiarrhythmics, antihypertensive agents, antilipidemic agents, bile acid sequestrants, cholesterol absorption inhibitors, fibric acid derivatives, HMG ⁇ COA reductase inhibitors, antilipidemic agents, nicotinic acid agents, beta adrenergic blocking agents, beta adrenergic blocking agents with diuretics, calcium channel blockers, diuretics, loop diuretics, potassium ⁇ sparing diuretics, thiazides & related diuretics, endothelin receptor antagonist, inotropic agents, vasodilators, coronary vasodilators, natriuretic peptides, pulmonary vasodilators, vasopressors, vasoprotective agents, central nervous system depressant, amphetamines, appetite suppressants, cholinesterase inhibitors, amino acids, blood modifiers, iron, digestive aids, fiber supplements, herbal
  • multiminerals phosphorous, potassium, zinc
  • prenatal formulations multivitamins, multivitamins with minerals, vitamin A, B vitamins, vitamin C, vitamin D analogues, vitamin E, dopamine receptor agonists, antacids (ingredients calcium carbonate alone or in combination with magnesium hydroxide, and/or aluminum hydroxide, or H2 ⁇ antagonists), antidiarrheals (e.g., loperamide), antiemetics, antiflatulents, anti ⁇ inflammatory agents, antispasmodics & anticholinergics, bowel evacuants, cytoprotective agents, digestive enzymes, duodenal ulcer adherent complex, histamine (H2) receptor antagonists, laxatives, bulk producing laxatives, emollient laxatives, enemas, saline laxatives, stimulant laxatives, proton pump inhibitors, homeopathic remedies, androgens, calcitonin, estrogens , glucocorticoids
  • prostaglandins prostaglandins, vasoconstrictors or sympathomimetics
  • osteoporosis agent bisphosphonates, calcitonin, otic preparations (including antibiotic & steroids), patent ductus arteriosus agents, phosphate binders, porphyria agents, prostaglandins, antianxiety agents, benzodiazepines, antidepressants, monoamine oxidase, inhibitors (MAOI), selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants, antipanic agents,
  • antipsychotic agents phenothiazines, bipolar agents, obsessive ⁇ compulsive disorder management agents, antitussives, narcotic antitussives, non ⁇ narcotic antitussives, bronchodilators, anticholinergics, anticholinergics with sympathomimetics,
  • sympathomimetics xanthine derivatives, decongestants, expectorants, leukotriene antagonists, leukotriene formation inhibitors, lung surfactants, cold & cough products with analgesics, sedatives & hypnotics, barbiturates, benzodiazepines, acne preparations, analgesics, anesthetics, anorectal preparations, antihistamines (e.g., chlorpheniramine maleate, dextromethorphan, or pseudoephedrine HCl), anti ⁇ infectives, antibiotics, antifungals, antivirals, anti ⁇ infectives, antineoplastics, antiperspirants, antipruritics, antipsoriatic agents, burn preparations deodorants, drying agents, emollients &
  • antihistamines e.g., chlorpheniramine maleate, dextromethorphan, or pseudoephedrine HCl
  • anti ⁇ infectives antibiotic
  • moisturizers, enzymes, hair growth stimulants, keratolytics, skin & mucous membrane agents including canker sore preparations, dental preparations, lozenges & sprays, mouth & throat products, oral rinses, saliva products, photosensitizing agents, scar tissue treatment, steroids , wart preparations, wound care products, smoking cessation aids, urinary tract agents including acidifiers, alkalinizers, analgesics, antibacterials, antispasmodics, benign prostatic hyperplasia (BPH) therapy, calcium oxalate stone prevention, cytoprotective agents, impotence agents, urinary tract agents, vaginal preparations including anti ⁇ infectives, estrogens, prostaglandins, or vasodilators, including cerebral vasodilators.
  • BPH benign prostatic hyperplasia
  • the active ingredient is selected from one or more of: adrenergic agonists such as clonidine; anxiolytics such as alprazolam (available as Xanax®); anti ⁇ psychotics such as clozapine (available as Clozaril®) and haloperidol (available as Haldol®); non ⁇ steroidal anti ⁇ inflammatories (NSAID's) such as dicyclofenac (available as Voltaren®) and etodolac (available as Lodine®), anti ⁇ histamines such as loratadine (available as Claritin®), astemizole (available as Hismanal®), nabumetone (available as Relafen®), fexofenadine (available as Allegra®), and clemastine (available as Tavist®); anti ⁇ emetics such as granisetron hydrochloride (available as Kytril®), serotonin 5 ⁇ HT3 receptor antagonists such as ondansetron (available
  • influenza vaccine cholera vaccine, bubonic plague vaccine, polio vaccine, hepatitis A vaccine, and rabies vaccine
  • attenuated vaccines e.g., yellow fever, measles, rubella, and mumps
  • toxoid vaccines e.g., tetanus and diphtheria
  • subunit vaccines e.g., subunit vaccine against Hepatitis B virus, virus ⁇ like particle (VLP) vaccine against human
  • fluoridating agents such as sodium fluoride, sodium monofluorophosphate (MFP) and stannous fluoride
  • stimulants such as caffeine, theobromine, theophylline, yohimbine, and nicotine
  • energy boosters such as methylxanthines (e.g., caffeine), B vitamins (e.g., Vitamin B12), herbs, guarana, yerba mate, acai, taurine, various forms of ginseng, maltodextrin, inositol, carnitine, creatine, glucuronolactone, ginkgo biloba, bitter orange extract,
  • coenzyme Q10 amino acids (e.g., L ⁇ carnitine), bee pollen, royal jelly, green tea extract, spirulina, gotu kola, and glucose; opioid antidiarrheals such as loperamide (available as Imodium®); sports supplements such as fish oil, dietary protein, creatine, caffeine, glutamine, essential fatty acids (e.g., (alpha ⁇ linolenic acid and linoleic acid), prohormones (e.g., chrysin and 4 ⁇ androstene ⁇ 3,6,17 ⁇ trione), and testosterone boosters (e.g., Fenugreek, Eurycoma longifolia, D ⁇ Aspartic acid, Boron, L ⁇ Carnitine and Tribulus terrestris); analgesics such as non ⁇ steroidal anti ⁇ inflammatory drugs (NSAIDs); COX ⁇ 2 inhibitors such as rofecoxib, celecoxib and etoricoxib; opiates such as morph
  • melatonin N ⁇ acetyl ⁇ 5 ⁇ methoxytryptamine
  • electrolytes such as sodium (NO, potassium (K+), calcium (Ca2+), magnesium (Mg2+), chloride (Cl ⁇ ), hydrogen phosphate (HPO4 2 ⁇ ), hydrogen carbonate (HCO3 ⁇ ), erectile dysfunction therapies (including, sildenafil, tadalafil, vardenafil, apomorphine, yohimbine and alprostadil), ondansetron (available as Zuplenz® and Zofran®), diphenhydramine (available as Benadryl®), simethicone (available as Gas ⁇ X®), melatonin (available as MelatoninPM®), benzocaine (available as Orajel®); buprenorphine and naloxone (available as Suboxone®), buprenorphine (available as Subutex®), phenylephrine
  • the composition comprises at least two active ingredients selected from: one or more cannabinoids, and/or ethyl pyruvate, and/or one or more terpenes.
  • said composition comprises one or more cannabinoids and ethyl pyruvate. In another embodiment, said composition comprises ethyl pyruvate and one or more terpenes. In another embodiment, said composition comprises one or more cannabinoids and one or more terpenes. In another embodiment, said composition comprises one or more cannabinoids, ethyl pyruvate, and one or more terpenes. In another embodiment, said composition comprises at least two cannabinoids. In another
  • said composition comprises at least two terpenes.
  • said composition comprises one or more cannabinoids and at least one other active ingredient; ethyl pyruvate and at least one other active ingredient; or one or more terpenes and at least one other active ingredient.
  • the composition comprises THC, CBD, melatonin and,
  • the composition comprises THC, CBD, melatonin, and CBN; THC, CBD, melatonin, CBN, limonene and beta ⁇ myrcene, THC, CBD, melatonin, CBN, and limonene, THC, CBD, melatonin, limonene and beta ⁇ myrcene, or THC, CBD, melatonin, CBN, and beta ⁇ myrcene.
  • the combined active ingredients in a composition of the present invention has synergistic activity, as compared to the additive activity of equivalent compositions comprising each active ingredient alone.
  • the composition comprises a one or more of a cannabinoid, cannabinoid extract, terpene, terpene extract, or a combination thereof.
  • the composition further comprises a surfactant.
  • a surfactant preferably a surfactant.
  • Some of the compositions of the present invention form emulsions, preferably nanoemulsions, microemulsions, or micelle dispersions in an aqueous medium.
  • the dispersion or emulsion is transparent at 0.1 wt% in an aqueous medium, e.g., water.
  • the composition is a rapid dispersing formulation, forming a transparent dispersion/emulsion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • the rapid dispersing formulation does not require agitation (e.g., shaking or stirring) to form a transparent dispersion or emulsion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • the composition form a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • the composition form a time selected from: 5, 10, 15, 20, 25, 30, 35,
  • compositions of the present invention that are rapid dispersing formulations are added to an aqueous medium dropwise using a dropper or dropper bottle or as a single bolus.
  • the composition is a non ⁇ aqueous formulation, i.e., the composition does not contain water.
  • the composition comprises less than; 10 wt%, 9 wt%, 8 wt%, 7 wt%, 6 wt%, 5 wt%, 4 wt%, 3 wt%, 2 wt%, 1 wt%, 0.5 wt%, 0.25 wt%, 0.1 wt%, or 0.05 wt% water.
  • the composition is a pharmaceutical composition.
  • the composition or pharmaceutical composition is an oral dosage form, e.g., a liquid, a solid or a semi ⁇ solid oral dosage form.
  • Another embodiment includes a unit dose (or serving) of the composition.
  • the active ingredient is an extract from a cannabis plant
  • Cannabisbis extract (“cannabis extract”). Cannabis plants belong to the family Cannabaceae, preferably
  • the cannabis extract may comprise one or more cannabinoids, or terpenes or other actives.
  • the cannabis extract comprises a cannabinoid, i.e., a “cannabinoid extract”.
  • a cannabinoid extract i.e., a “cannabinoid extract”.
  • the terpene is in the form of an extract from a cannabis or other plant
  • the cannabis, cannabinoid, or terpene extract is from a cannabis plant selected from Cannabis sativa, Cannabis indica, or Cannabis hybrid.
  • the cannabis, cannabinoid or terpene extract is an extract of Cannabis sativa.
  • the cannabis, cannabinoid or terpene extract is an extract of Cannabis indica.
  • the cannabis, cannabinoid or terpene extract is an extract of Cannabis hybrid.
  • the cannabis, cannabinoid or terpene extract is a distillate.
  • the cannabinoid distillate is the product of short path distillation of a cannabinoid extract.
  • the cannabinoid or terpene is synthetic.
  • the cannabinoid extract comprises total cannabinoid(s) in an amount selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, 90 ⁇ 95 wt%, or >99 wt% total cannabinoid(s).
  • the total concentration of cannabinoid(s) in a composition of the present invention is 1 ⁇ 200 mg/mL. In further embodiments, the total concentration of
  • cannabinoid(s) in a composition of the present invention is selected from: 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, or 150 ⁇ 200 mg/mL.
  • the total concentration of cannabinoid(s) in a composition of the present invention is ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL. In another embodiment, the total concentration of cannabinoid(s) in a composition of the present invention is selected from: 0.01 ⁇ 1 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5.7.5 wt%, 7.5 ⁇ 10 wt%,10 ⁇ 12.5 wt%, 12.5 ⁇ 15 wt%, 7.5 ⁇ 15 wt%, 10 ⁇ 15 wt%, 10 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, or >50 wt%.
  • the composition comprises at least one terpene.
  • the terpene is found in Cannabis sativa, Cannabis indica, or Cannabis hybrid.
  • the terpene is extracted from a plant species, preferably a species of Cannabis (e.g., Cannabis sativa, Cannabis indica, Cannabis hybrid or other).
  • the terpene is synthetic.
  • the terpene is selected from any suitable plant species.
  • alpha ⁇ bisabolol alpha ⁇ phellandrene, alpha ⁇ pinene, alpha ⁇ terpinene, alpha ⁇ terpineol, beta ⁇ caryophyllene, beta ⁇ pinene, borneol, cadinene, camphene, camphor, carvacrol, caryophyllene acetate, caryophyllene oxide, cedrane, citral, citronellol, dextro carvone, dextro fenchone, eucalyptol (1,8 ⁇ cineole), eugenol, farnesene, gama ⁇ 3 ⁇ carene, gamma ⁇ terpinene, geraniol, geranyl acetate, guaiene, humul
  • the composition further comprises at least one terpene.
  • the at least one terpene is any one, two, three, four, five, six, or all six terpenes selected from the group consisting of beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, eucalyptol, and myrcene.
  • the at least one terpene is any one, two, three, four, or all five selected from beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, or eucalyptol.
  • the composition comprises beta ⁇ caryophyllene.
  • the composition comprises myrcene. In another embodiment, the composition comprises linalool. In another embodiment, the composition comprises limonene. In another embodiment, the composition comprises alpha ⁇ pinene. In another embodiment, the composition comprises eucalyptol. In another embodiment, the composition comprises beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • the surfactants of the present invention include pharmaceutically acceptable or food grade surfactants. Surprisingly, some compositions comprising high concentrations of surfactant, including compositions containing no exogenously added fatty acid,
  • the surfactant has an HLB value greater than 9, 10, 11, 12, 13, 14, 15, 16, or greater than 16. In other embodiments, the surfactant has an HLB value between 9 ⁇ 17, 9 ⁇ 16.7, 9 ⁇ 16, 9 ⁇ 15, 9 ⁇ 14, 10 ⁇ 17, 10 ⁇ 16.7, 10 ⁇ 16, 10 ⁇ 15, 12 ⁇ 14, 12 ⁇ 16, 14 ⁇ 16, 14 ⁇ 17, 15 ⁇ 17, and between 10 ⁇ 14. In a preferred embodiment, the surfactant has an HLB value between 14 ⁇ 16, In a further preferred embodiment, the surfactant has an HLB value of about 15.
  • the composition comprises at least two surfactants, independently, with an HLB value selected from 9, 10, 11, 12, 13, 14, 15, 16, greater than 16, 9 ⁇ 17, 9 ⁇ 16.7, 9 ⁇ 16, 9 ⁇ 15, 9 ⁇ 14, 10 ⁇ 17, 10 ⁇ 16.7, 10 ⁇ 16, 10 ⁇ 15, 12 ⁇ 14, 12 ⁇ 16, 14 ⁇ 16, 14 ⁇ 17, 15 ⁇ 17, and between 10 ⁇ 14.
  • HLB value selected from 9, 10, 11, 12, 13, 14, 15, 16, greater than 16, 9 ⁇ 17, 9 ⁇ 16.7, 9 ⁇ 16, 9 ⁇ 15, 9 ⁇ 14, 10 ⁇ 17, 10 ⁇ 16.7, 10 ⁇ 16, 10 ⁇ 15, 12 ⁇ 14, 12 ⁇ 16, 14 ⁇ 16, 14 ⁇ 17, 15 ⁇ 17, and between 10 ⁇ 14.
  • the surfactant is selected from: PEG 15 hydroxystearate (Solutol HS15), polyoxyl ⁇ 10 ⁇ Oleyl Ether (BRIJ® 97), polyethylene glycol 25 hydrogenated
  • polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40, Cremophor RH40), polyethylene ⁇ polypropylene glycol (poloxamer 124), PEG 8 caprylic/capric glycerides (Labrasol), PEG 300 oleic glycerides (Labrafil M 1944), diethylene glycol monoethyl ether (Transcutol), lauroyl macrogol 32 glycerides (GELUCIRE® 44/14), polyethylene glycol 400 (PEG 400), propylene glycol laurate (Lauroglycol FCC), D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS), polyethylene ⁇ polypropylene glycol (poloxamer 188), polyethylene ⁇ polypropylene glycol (poloxamer 407), polyvinyl pyrrolidone (e.g., Mw 28 ⁇ 34 kDa, Mw 44 ⁇ 54kDa (e.g., Kollidon 30), polyvin
  • microcrystalline cellulose MCC
  • lecithin polyethylene ⁇ polypropylene glycol (poloxamer 124), polyethylene glycol sorbitan monolaurate (polysorbate 20, TWEEN 20), polyethylene glycol sorbitan monopalmitate (polysorbate 40, TWEEN 40), polyethylene glycol sorbitan monostearate (polysorbate 60, TWEEN 60), polyethylene glycol sorbitan tristearate
  • the surfactant is selected from: polyoxyl ⁇ 10 ⁇ Oleyl Ether (BRIJ® 97), polyethylene glycol 25 hydrogenated castor oil, polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40, Cremophor RH40, Croduret 40), polyethylene ⁇ polypropylene glycol (poloxamer 124), PEG 8 caprylic/capric glycerides (Labrasol), PEG 300 oleic glycerides (Labrafil M 1944), diethylene glycol monoethyl ether (Transcutol), sorbitane monooleate (Span 80), Lauroyl macrogol 32 glycerides (GELUCIRE® 44/14), polyethylene glycol 400 (PEG 400), propylene glycol laurate (Lauroglycol FCC), polysorbate 20 (TWEEN® 20), polysorbate 40 (TWEEN® 40), polysorbate 60 (TWEEN® 60), polysorbate 80 (TWEEN®
  • Tracacanth gum hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), microcrystalline cellulose (MCC), lecithin, or a combination thereof.
  • HPMC hydroxypropyl methylcellulose
  • CMC carboxymethyl cellulose
  • MMC microcrystalline cellulose
  • lecithin or a combination thereof.
  • the surfactant is selected from: Lauroyl macrogol 32 glycerides (GELUCIRE® 44/14), polyethylene glycol 400 (PEG 400), propylene glycol laurate (Lauroglycol FCC), polysorbate 20 (TWEEN® 20), polysorbate 40 (TWEEN® 40), polysorbate
  • HPMC methylcellulose
  • CMC carboxymethyl cellulose
  • MMC microcrystalline cellulose
  • lecithin or a combination thereof.
  • the surfactant is selected from: Lauroyl macrogol 32 glycerides (GELUCIRE® 44/14), polyethylene glycol 400 (PEG 400), propylene glycol laurate (Lauroglycol FCC), polysorbate 20 (TWEEN® 20), polysorbate 40 (TWEEN® 40), polysorbate 60 (TWEEN® 60), polysorbate 80 (TWEEN® 80), D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS), polyethylene ⁇ polypropylene glycol (poloxamer 188), polyethylene ⁇ polypropylene glycol (poloxamer 407), polyvinyl pyrrolidone (Kollidon 30), polyvinyl pyrrolidone (Kollidon 90), or a combination thereof.
  • the surfactant is TPGS and/or lauroyl macrogol 32
  • the surfactant is polysorbate 80.
  • the surfactant is polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40) and/or polysorbate 80.
  • the surfactant is TPGS and polysorbate 80.
  • the surfactant is polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • polyethylene glycol (PEG) 40 hydrogenated castor oil unexpectedly better at solubilizing cannabinoids as compared with polysorbate 80.
  • compositions generally required 3 ⁇ 5 times less polyethylene glycol (PEG) 40 hydrogenated castor oil compared with polysorbate 80 to form a transparent emulsion or micellar dispersion in water.
  • the composition comprises at least one co ⁇ solvent.
  • the co ⁇ solvent is selected from at least one of: ethanol, ethyl lactate, ethyl olelate, glycerol, or propylene glycol.
  • said co ⁇ solvent is selected from at least one of: ethanol, ethyl lactate, or propylene glycol.
  • the co ⁇ solvent is ethanol.
  • the composition comprises an active ingredient, e.g., cannabinoid or cannabinoid extract, a surfactant, and a co ⁇ solvent(s) in an amount selected from: 0 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, 75 ⁇ 80 wt%, 80 ⁇ 85 wt%, 85 ⁇ 90 wt%, 90 ⁇ 95 wt%, or 95 ⁇ 97 wt% co ⁇ solvent(s).
  • said co ⁇ solvent(s) is present in an amount selected from 15 ⁇ 40 wt
  • composition comprises 20 ⁇ 30 wt%, 20 ⁇ 25 wt%, or 25 ⁇ 30 wt% co ⁇ solvent(s).
  • a composition comprises a cannabinoid or cannabinoid extract, polysorbate 80, and a co ⁇ solvent, e.g., ethanol, wherein said composition comprises at least
  • a composition comprises a cannabinoid or cannabinoid extract, polyethylene glycol (PEG) 40 hydrogenated castor oil, and a co ⁇ solvent, e.g., ethanol, wherein said composition comprises at least about 25 wt% co ⁇ solvent and a wt% ratio of cannabinoid or cannabinoid extract:polyethylene glycol (PEG) 40 hydrogenated castor oil that is at least 1:1 ⁇ 2, 1:2 ⁇ 5, 1:1.5 ⁇ 4, 1:2 ⁇ 4, or at least 1:2 ⁇ 3.
  • the co ⁇ solvent is present in an amount that is about 20 ⁇ 99%, 25 ⁇ 99%, 20 ⁇ 50%, 25 ⁇ 75%, 25 ⁇ 50%, 25 ⁇ 40%, 25 ⁇ 35%. In a further embodiment, the co ⁇ solvent is ethanol.
  • the composition comprises an active ingredient, e.g., an active ingredient
  • cannabinoid or cannabinoid extract and a surfactant wherein the surfactant is in an amount selected from: at least 5 wt%, at least 10 wt%, at least 15 wt%, at least 20 wt%, at least 25 wt%, at least 30 wt%, at least 35 wt%, at least 40 wt%, at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 90 wt%, at least 95 wt%, at least 97 wt%, 0 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 w
  • the surfactant has an HLB value greater than 9, greater than 10, between 9 ⁇ 17, between 9 ⁇ 16.7, between 9 ⁇ 16, between 9 ⁇ 15, between 10 ⁇ 17, between 10 ⁇ 16.7, between 10 ⁇ 16, between 10 ⁇ 15, between 10 ⁇ 14, between 9 ⁇ 13.4, between 14 ⁇ 16, between 14 ⁇ 17, between 15 ⁇ 17, or between 10 ⁇ 13.4.
  • the surfactant has an HLB value of between 12 ⁇ 13, 13 ⁇ 14, 14 ⁇ 15, or 15 ⁇ 16.
  • the surfactant has an HLB value of about 12, 13, 14, or 15.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises an active ingredient, e.g., cannabinoid or cannabinoid extract, and at least 40%, at least 45%, at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 90 wt%, at least 95 wt%, or at least 97 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 45 ⁇ 55 wt%, 45 ⁇ 65 wt%, 46 ⁇ 65 wt%, 47 ⁇ 65 wt%, 48 ⁇ 65 wt%, 49 ⁇ 65 wt%, 50 ⁇ 65 wt%, 51 ⁇ 65 wt%,
  • the surfactant has an HLB value of about 12 ⁇ 15, 12 ⁇ 13, 12.5 ⁇ 13.5, 13.5 ⁇ 14.5, or 14.5 ⁇ 15.5.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • SEDDS Self ⁇ emulsifying drug delivery systems
  • Examples of patents demonstrating the potential use of SEDDS or lipid delivery systems for lipophilic drugs include U.S. Pat. Nos. 5,484,801; 5,798,333; 5,965,160; 6,008,228; 6,730,330; 9,265,724; U.S. Patent Application No. 20050209345; 20060160888; US20140357708; 20160184258; and PCT Publications WO96/39142 and WO2016147186.
  • Patent Application 20160184258 exemplify a few SEDDS formulations comprising ⁇ 9 THC.
  • the present invention includes improved formulations comprising at least one active ingredient and at least one fatty acid, at least one monoglyceride, at least one diglyceride, or at least one triglyceride, including improved SEDDS formulations.
  • the composition comprises:
  • At least one fatty acid at least one monoglyceride, at least one diglyceride, or at least one triglyceride, or a combination thereof; and, optionally,
  • At least one surfactant at least one surfactant.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • composition comprises:
  • a cannabinoid or cannabinoid extract and at least one surfactant.
  • composition comprises:
  • At least one surfactant at least one surfactant; and, optionally,
  • At least one fatty acid at least one monoglyceride, at least one diglyceride, or at least one triglyceride, or a combination thereof.
  • the active ingredient is selected from a cannabinoid
  • cannabinoid extract cannabinoid extract, terpene, or terpene extract.
  • the composition comprises at least one fatty acid. In another embodiment, the composition comprises at least one monoglyceride. In another
  • the composition comprises at least one diglyceride. In another embodiment, the composition comprises at least one triglyceride. In other embodiments, the composition comprises at least one fatty acid and at least one monoglyceride; at least one fatty acid and at least one diglyceride; at least one fatty acid and at least one triglyceride; at least one monoglyceride and at least one diglyceride; at least one monoglyceride and at least one triglyceride; at least one diglyceride and at least one triglyceride; at least one fatty acid, at
  • the fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof is an oil.
  • the oil is selected from anise oil, apricot kernel oil PEG ⁇ 6 esters, apricot kernel oil, beeswax, borage oil, canola oil, castor oil, polyoxyl 35 castor oil, polyoxyl 40 hydrogenated castor oil, polyoxyl 40 castor oil, polyoxyl 60 hydrogenated castor oil, hydrogenated castor oil, polyoxyl 60 castor oil, cinnamon oil, clove oil, coconut oil fractioned, coconut oil, coconut oil ⁇ lecithin, coriander oil, corn oil PEG ⁇ 6 esters, corn oil PEG ⁇ 8 esters, corn oil, cottonseed oil hydrogenated, cottonseed oil, cottonseed oil, hydrogenated soybean oil, hydrogenated vegetable oils, kernel oil PEG ⁇ 6 esters, kernel oil, lemon oil, mineral oil (light), mineral oil, neutral oil, nutmeg oil, olive oil PEG ⁇
  • the fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof is a fat. In another embodiment, the fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof is exogenously added fatty acid,
  • exogenously added means other than any fatty acids, monoglycerides, diglycerides, triglycerides, or combinations thereof, that were originally present in a cannabis plant, or other plant extract, and remains in the extract, e.g., a cannabinoid extract, after the extraction/distillation process.
  • pressed cannabis/hemp seed oil added to a composition of the present invention is exogenously added.
  • the only exogenously added fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof is a flavoring oil, e.g., flavor compounds diluted with and MCT or other oil.
  • the flavoring oil is an essential oil.
  • the essential oil is produced by distillation (e.g., steam distillation), solvent extraction (example, a hydrocarbon such as hexane or supercritical carbon dioxide), or by expression.
  • the cannabinoid extract is essentially free of fatty acids, monoglycerides, diglycerides, or triglycerides. In a further embodiment, the cannabinoid extract is essentially free of fatty acids. In another embodiment, the cannabinoid extract is essentially free of monoglycerides. In another embodiment, the cannabinoid extract is essentially free of diglycerides. In another embodiment, the cannabinoid extract is
  • composition is essentially free of triglycerides. In another embodiment, the composition is essentially free of exogenously added fatty acids. In another embodiment, the composition is essentially free of exogenously added monoglycerides. In another embodiment, the composition is
  • composition is essentially free of exogenously added triglycerides. In another embodiment, the composition is essentially free of exogenously added fats or oils.
  • the composition comprises an active ingredient, and at least 5 wt%, at least 10 wt%, at least 15 wt%, at least 20 wt%, at least 25 wt%, at least 30 wt%, at least 35 wt%, at least 40 wt%, at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 90 wt%, at least 91 wt%, at least 92 wt%, at least 93 wt%, at least 94 wt%, or at least 95 wt% of exogenously added fat, oil, fatty acid, monoglyceride, diglyceride, triglyceride, MCT, LCT, or a combination thereof.
  • the active ingredient is selected from a
  • cannabinoid cannabinoid extract
  • terpene cannabinoid extract
  • terpene extract cannabinoid extract
  • the composition comprises an active ingredient, and not more than: 1 wt %, 2 wt %, 3 wt %, 4 wt %, 5 wt %, 6 wt %, 7 wt %, 8 wt %, 9 wt %, 10 wt %, 11 wt %, 12 wt %, 13 wt %, 14 wt %, 15 wt %, 16 wt %, 17 wt %, 18 wt %, 19 wt %, 20 wt %, 25 wt%, 30 wt%, 35 wt%, 40 wt%, 50 wt%, 55 wt%, 60 wt%, 65 wt%, 70 wt%, 75 wt%, 80 wt%, 85 wt%, 90 wt%, or 95 wt% of exogenously added fat, oil, fatty acid, mono
  • the composition comprises an active ingredient, and 0 ⁇ 2.5 wt%, 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 11 wt%, 0 ⁇ 12 wt%,0 ⁇ 13 wt%, 0 ⁇ 14 wt%, 0 ⁇ 15 wt%, 0 ⁇ 16 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, 75 ⁇ 80 wt%, 80 ⁇ 85 wt%, 85 ⁇ 90 wt%, 87 ⁇ 92 wt%, 90 ⁇ 95 wt%, or
  • the composition comprises an active ingredient, and at least 5 wt%, at least 10 wt%, at least 15 wt%, at least 20 wt%, at least 25 wt%, at least 30 wt%, at least 35 wt%, at least 40 wt%, at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 90 wt%, at least 91 wt%, at least 92 wt%, at least 93 wt%, at least 94 wt%, or at least 95 wt% of fat, oil, or combination thereof; fatty acid, monoglyceride, diglyceride, triglyceride, or a
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises an active ingredient, and not more than: 1 wt %, 2 wt %, 3 wt %, 4 wt %, 5 wt %, 6 wt %, 7 wt %, 8 wt %, 9 wt %, 10 wt %, 11 wt %, 12 wt %, 13 wt %, 14 wt %, 15 wt %, 16 wt %, 17 wt %, 18 wt %, 19 wt %, 20 wt %, 25 wt%, 30 wt%, 35 wt%, 40 wt%, 50 wt%, 55 wt%, 60 wt%, 65 wt%, 70 wt%, 75 wt%, 80 wt%, 85 wt%, 90 wt%, or 95 wt% of fat, oil, or a combination thereof; fatty acid
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises an active ingredient, and 0 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, 75 ⁇ 80 wt%, 80 ⁇ 85 wt%, 85 ⁇ 90 wt%, 87 ⁇ 92 wt%, 90 ⁇ 95 wt%, or 91 ⁇ 96 wt% of fat, oil, or a combination thereof; fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof; fat, oil, or a combination thereof.
  • the active ingredient is selected from a cann
  • the monoglyceride, diglyceride, or triglyceride is a medium chain monoglyceride, diglyceride, or triglyceride and/or a long chain monoglyceride, diglyceride triglyceride.
  • the triglyceride is a medium chain triglyceride (MCT).
  • the triglyceride is a long chain
  • the composition comprises: a cannabinoid, and at least one surfactant from, polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40), D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS), polysorbate 80, or lauroyl macrogol 32 glycerides, or a combination thereof.
  • PEG polyethylene glycol
  • TPGS D ⁇ Tocopherol polyethylene glycol 1000 succinate
  • TPGS D ⁇ Tocopherol polyethylene glycol 1000 succinate
  • polysorbate 80 or lauroyl macrogol 32 glycerides, or a combination thereof.
  • lauroyl macrogol 32 glycerides or a combination thereof.
  • the composition comprises a cannabinoid, TPGS, lauroyl macrogol 32 glycerides, and a MCT and/or LCT.
  • the composition comprises a cannabinoid, TPGS, lauroyl macrogol 32 glycerides, and a MCT.
  • the composition comprises a cannabinoid, TPGS, lauroyl macrogol 32 glycerides, and a LCT.
  • the lauroyl macrogol 32 glycerides is GELUCIRE 44/14.
  • the composition comprises a cannabinoid, polysorbate 80, and TPGS.
  • the composition comprises a cannabinoid, polysorbate 80, and TPGS.
  • composition of the invention comprises a cannabinoid, polysorbate 80, and polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • composition comprises a cannabinoid and polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • composition of the invention comprises:
  • an amount of active ingredient(s) selected from 0.5 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 2.5 ⁇ 7.5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 7.5 ⁇ 10 wt%, 7.5 ⁇ 12.5 wt%, or 10 ⁇ 12.5 wt%;
  • surfactant(s) selected from 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 55 wt%, 45 ⁇ 50 wt%, 46 ⁇ 56%, 47 ⁇ 57%, 48 ⁇ 58%, 49 ⁇ 59%, 45 ⁇ 55 wt%, 45 ⁇ 65 wt%, 46 ⁇ 65 wt%, 47 ⁇ 65 wt%, 48 ⁇ 65 wt%, 49 ⁇ 65 wt%, 50 ⁇ 65 wt%, 51 ⁇ 65 wt%, 52 ⁇ 65 wt%, 53 ⁇ 65 wt%, 54 ⁇ 65 wt%, 55 ⁇ 65 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, or 75 ⁇ 80 wt%; and,
  • an amount of co ⁇ solvent selected from 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, or 35 ⁇ 40 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, 75 ⁇ 80 wt%, 80 ⁇ 85 wt%, 85 ⁇ 90 wt%, 90 ⁇ 95 wt%, or 95 ⁇ 99 wt%.
  • the composition further comprises: an amount of oil, preferably MCT, LCT, MCT and LCT, selected from: 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 11 wt%, 0 ⁇ 12
  • wt% 0 ⁇ 13 wt%, 0 ⁇ 14 wt%, 0 ⁇ 15 wt%, 0 ⁇ 16 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 5 wt%, 1 ⁇ 10 wt%, 1 ⁇ 20 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 5 ⁇ 11 wt%, 5 ⁇ 12 wt%, 5 ⁇ 13 wt%, 5 ⁇ 14 wt%, 5 ⁇ 15 wt%, 5 ⁇ 16 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 wt%, 10 ⁇ 20 wt%, 15 ⁇ 20 wt%, or 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, or 25 ⁇ 50% wt%.
  • the composition further comprises: an amount of flavoring or flavor agents selected from 0 ⁇ 1 wt%, 0 ⁇ 2 wt%, 0 ⁇ 3 wt%, 0 ⁇ 3.5 wt%, 0 ⁇ 3.75 wt%, 0 ⁇ 4 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 5 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 wt%, 10 ⁇ 20 wt%, 15 ⁇ 20 wt%, or 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, or 25 ⁇ 50% wt%.
  • an amount of flavoring or flavor agents selected from 0 ⁇ 1 wt%, 0 ⁇ 2 wt%, 0 ⁇ 3 wt%, 0 ⁇ 3.5 wt%, 0 ⁇ 3.
  • the composition further comprises: an amount of sweetener selected from 0 ⁇ 5 wt%, 0 ⁇ 7.5 wt%, 1 ⁇ 2 wt%, 2 ⁇ 3 wt%, 2.5 ⁇ 5%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 6 wt%, 5 ⁇ 7.5 wt%, 7.5 ⁇ 10 wt%, or 5 ⁇ 10 wt%.
  • an amount of sweetener selected from 0 ⁇ 5 wt%, 0 ⁇ 7.5 wt%, 1 ⁇ 2 wt%, 2 ⁇ 3 wt%, 2.5 ⁇ 5%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 6 wt%, 5 ⁇ 7.5 wt%, 7.5 ⁇ 10 wt%, or 5 ⁇ 10 wt%.
  • flavoring may represent a single species of flavor agent (e.g., limonene) or a mixture of flavor agent species (e.g., limonene, linalool, citral, citronellol, geranyl acetate and perillaldehyde) combined to produce a certain flavor.
  • the flavoring may further comprise a vehicle, e.g., MCT, for solubilizing the flavor agent(s).
  • a “flavor agent” is a single molecule, e.g., limonene, used alone or in combination with other flavor agent(s) to produce a certain flavor, e.g., citrus or orange, of a flavoring.
  • a flavoring is normally supplied as a concentrate for dilution and for the purpose of imparting a flavor or taste ⁇ masking a substance.
  • the surfactant is polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • the co ⁇ solvent is selected from ethanol, ethyl lactate, and/or propylene glycol.
  • the co ⁇ solvent is a mixture of co ⁇ solvents, e.g., ethanol and propylene glycol.
  • the surfactant is polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40) and the co ⁇ solvent is selected from ethanol, ethyl lactate, and/or propylene glycol.
  • At least one active ingredient is a cannabinoid
  • the surfactant is polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40)
  • the co ⁇ solvent is selected from ethanol, ethyl lactate, and/or propylene glycol.
  • the composition comprises: 3 ⁇ 5 wt% or 5 ⁇ 10 wt% cannabinoid or cannabinoid extract; 45 ⁇ 65 wt%, 50 ⁇ 65 wt%, 45 ⁇ 55 wt%, 52 ⁇ 62 wt%, 55 ⁇ 65 wt%, or >65 wt% polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40); 15 ⁇ 30 wt%, 20 ⁇ 25 wt%, 20 ⁇ 30 wt%, 20 ⁇ 35 wt%, 35 ⁇ 45 wt%, or >45 wt% co ⁇ solvent selected from ethanol, ethyl lactate, and/or propylene glycol; 2.5 ⁇ 7.5%, 2.5 ⁇ 5 wt%, or 2 ⁇ 4 wt% sweetener(s) (e.g., sucralose); 1 ⁇ 2 wt%, 2 ⁇ 3 wt%, 2.5 ⁇ 5%, 3 ⁇ 4 wt%, 4 ⁇ 5
  • ethanol, ethyl lactate, and/or propylene glycol as a co ⁇ solvent to a composition comprising polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40) significantly reduced the dissolution time from hours to minutes or seconds.
  • PEG polyethylene glycol
  • Kolliphor RH40 hydrogenated castor oil
  • an aqueous emulsion comprising 0.1 ⁇ 0.2 vol.% of a composition of the invention is transparent, with an estimated average particle size ⁇ 50 nm, ⁇ 75 nm, ⁇ 100 nm, ⁇ 125 nm, ⁇ 150 nm, ⁇ 200 nm, ⁇ 250 nm.
  • the composition comprises polysorbate 80 and TPGS.
  • One surprising advantage of these compositions is a significant reduction or elimination of leakage when unsealed hard gelatin capsules are filled with the composition.
  • the formulations when added to an aqueous medium, have fast dissolution rates and form transparent mirco ⁇ or nanoemulsions.
  • the formulations comprise 30 ⁇ 50 wt% polysorbate 80, 50 ⁇ 70 wt% TPGS, and 1 ⁇ 20 wt% active ingredient.
  • the formulations comprise 40 ⁇ 50 wt% polysorbate 80, 40 ⁇ 50 wt% TPGS, and 1 ⁇ 20 wt% active ingredient.
  • the formulations comprise 30 ⁇ 50 wt% polysorbate 80, 50 ⁇ 70 wt% TPGS, and 5 ⁇ 15 wt% cannabinoid or cannabinoid extract.
  • the formulations comprise 40 ⁇ 50 wt% polysorbate 80, 40 ⁇ 50 wt% TPGS, and 5 ⁇ 20 wt% cannabinoid or cannabinoid extract. In further embodiments, the formulations comprise 40 ⁇ 50 wt% polysorbate 80, 40 ⁇ 50 wt% TPGS, and 5 ⁇ 10% cannabinoid or cannabinoid extract. In further embodiments, the formulations comprise 40 ⁇ 50 wt% polysorbate 80, 40 ⁇ 50 wt% TPGS, and 5 ⁇ 10 wt% cannabinoid or cannabinoid extract. In a further embodiment, the composition consists of 45 wt% polysorbate 80, 45% TPGS, and 10 wt% THC ⁇ distillate.
  • the composition comprises an active ingredient, and polysorbate 80.
  • at least one active ingredient is selected from a
  • the composition consists of an active ingredient, and polysorbate 80.
  • at least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or
  • the composition comprises an active ingredient, polysorbate 80 and a MCT and/or LCT.
  • at least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract.
  • the composition comprises an active ingredient, polysorbate 80 and an MCT.
  • the composition comprises an active ingredient, polysorbate 80 and an LCT.
  • at least one active ingredient is selected from a
  • cannabinoid cannabinoid extract
  • terpene cannabinoid extract
  • terpene extract cannabinoid extract
  • the composition comprises CBD, ethyl pyruvate, optionally THC, optionally at least one terpene, and polysorbate 80. and/or polyethylene glycol (PEG) 40 hydrogenated castor oil.
  • the composition further comprises THC and/or one or more terpene.
  • the terpene in selected from any one, two, three, four, five, or all six of the terpenes selected from the group consisting of: myrcene, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • the composition comprises one, two, three, four, or all five terpenes selected from the group consisting of beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • the composition consists of CBD, ethyl pyruvate, THC, one or more terpene, and polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil.
  • the composition comprises a cannabinoid extract or terpene extract.
  • the composition comprises CBD, ethyl pyruvate, THC, one or more terpene, polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil, and a MCT and/or LCT.
  • the composition comprises a cannabinoid extract or terpene extract.
  • the composition comprises CBD, ethyl pyruvate, THC, one or more terpene, polysorbate 80 and/or polyethylene glycol (PEG) 40 hydrogenated castor oil, and an MCT.
  • the composition comprises a cannabinoid extract and/or terpene extract.
  • the composition comprises THC, CBD, melatonin and, optionally, one or more selected from CBN, D ⁇ limonene and/or beta ⁇ myrcene.
  • the composition comprises: (a) THC, CBD, melatonin, and CBN; (b) THC, CBD, melatonin, CBN, limonene and beta ⁇ myrcene; (c) THC, CBD, melatonin, CBN, and limonene; (d) THC, CBD, melatonin, limonene and beta ⁇ myrcene; or (e) THC, CBD, melatonin, CBN, and beta ⁇ myrcene.
  • a unit dose of one of the above compositions comprises 0 ⁇ 10, 0 ⁇ 5, 1 ⁇ 9, 2 ⁇ 8, 3 ⁇ 7, 4 ⁇ 6 or about 5 mg THC; 20 ⁇ 60, 30 ⁇ 50, 35 ⁇ 45, 37.5 ⁇ 42.5 or about 40 mg CBD; 0 ⁇ 10, 0 ⁇ 5, 1 ⁇ 9, 2 ⁇ 8, 3 ⁇ 7, 4 ⁇ 6 or about 5 mg CBN (if present); 0 ⁇ 13, 4 ⁇ 12, 5 ⁇ 11, 6 ⁇ 10, 7 ⁇ 9, 7.5 ⁇ 8.5, or about 8 mg D ⁇ limonene (if present); 0 ⁇ 10, 0.25 ⁇ 6 ⁇ 8, 0.5 ⁇ 6, 0.5 ⁇ 4, 1.0 ⁇ 3.5, 1.0 ⁇ 3, 1.5 ⁇ 2.5, or about 2 mg beta ⁇ myrcene (if present); and 0 ⁇ 10, 0.25 ⁇ 7, 0.25 ⁇ 5, 1 ⁇ 5, 1 ⁇ 2.5, 0.25 ⁇ 2.5, 0.25 ⁇ 2, 0.5 ⁇ 2, 1 ⁇ 2, or about 0.25 ⁇ 1 mg melatonin.
  • CBD CBD
  • the composition comprises about 5 mg THC, about 40 mg CBD, about 5 mg CBN, about 0.25 ⁇ 1 mg melatonin, about 8 mg D ⁇ limonene, and about 2 mg beta ⁇ myrcene.
  • the composition comprises at least one active ingredient; a MCT and/or LCT;
  • compositions in Table 1 wherein the wt% of active ingredient, MCT and/or LCT, first surfactant, and second surfactant (where the first and second surfactant are different) is selected from one of the compositions in Table 1 below.
  • Each of the composition in Table 1 is an individual embodiment of the present invention.
  • At least one active ingredient of any one composition selected from 1 ⁇ 115 of Table 1 is a cannabinoid, cannabinoid extract, terpene, or terpene extract. In further embodiments, at least one active ingredient is a cannabinoid. In further embodiments, at least one active ingredient is a cannabinoid extract. In further embodiments,
  • At least one active ingredient is a terpene. In further embodiments, at least one active ingredient is a terpene extract.
  • a composition selected from one of the compositions 1 ⁇ 115 of Table 1 is a non ⁇ aqueous composition.
  • a composition selected from one of the compositions 1 ⁇ 115 of Table 1 is a solid or semi ⁇ solid composition.
  • a composition selected from one of the compositions from 1 ⁇ 115 of Table 1 comprises: 0.01 ⁇ 0.1 wt%, 0.1 ⁇ 1 wt%, 1 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 3 wt%, 2.5 ⁇ 5 wt%, 3 ⁇ 8 wt%, 5.7.5 wt%, 5 ⁇ 10 wt%, 7.5 ⁇ 10 wt%, 7.5 ⁇ 15 wt%, 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, 9 ⁇ 11 wt%, more than 8 wt%, more than 10 wt%, 10 ⁇ 12.5 wt%, 12.5 ⁇ 15 wt%, 10 ⁇ 15 wt%, 10 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, or >50 wt% of an active ingredient(s), preferably comprising a cannabinoid or cannabinoid extract.
  • a composition selected from one of the compositions from 1 ⁇ 6, 10 ⁇ 15, 17 ⁇ 103, and 107 ⁇ 115 of Table 1 comprises 1 ⁇ 5 wt% of an active ingredient(s), preferably comprising a cannabinoid or cannabinoid extract.
  • the cannabinoid extract comprises total cannabinoid(s) in an amount selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, 90 ⁇ 95 wt%, or >99 wt% total cannabinoid(s).
  • the total concentration of the active ingredient, e.g., cannabinoid(s), in a composition selected from one of the compositions from 1 ⁇ 115 of Table 1 is 1 ⁇ 200 mg/mL. In further embodiments, the total concentration of the active ingredient, e.g., cannabinoid(s), in a composition selected from one of the compositions from 1 ⁇ 115 of Table 1 is 1 ⁇ 200 mg/mL. In further embodiments, the total concentration of the active ingredient, e.g., cannabinoid(s), in a composition selected from one of the compositions from 1 ⁇ 115 of Table 1 is 1 ⁇ 200 mg/mL. In further embodiments, the total concentration of the active
  • ingredient(s), e.g., cannabinoid(s), in a composition selected from 1 ⁇ 115 of Table 1 is selected from: 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, or 150 ⁇ 200 mg/mL.
  • cannabinoid(s) in a composition selected from one of the compositions from 1 ⁇ 115 of Table 1 is ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL.
  • a composition selected from 1 ⁇ 115 of Table 1 comprises the active ingredient(s), e.g., cannabinoid(s), in an amount selected from: 0.25 ⁇ 1 mg, 0.5 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5 ⁇ 7.5 mg, 7.5 ⁇ 10 mg, 10 ⁇ 12.5 mg, 12.5 ⁇ 15 mg, 15 ⁇ 20mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, or 70 ⁇ 75 mg.
  • the cannabinoid is THC.
  • the cannabinoids are THC and CBD.
  • a composition selected from 1 ⁇ 115 of Table 1 comprises ⁇ 0.001 mg, 0.001 ⁇ 0.25 mg, or 0.25 ⁇ 1 mg of cannabinoid(s).
  • a composition selected from compositions 1 ⁇ 115 of Table 1 comprises MCT.
  • the composition comprises MCT, but not LCT.
  • the MCT is an oil.
  • a composition of Table 1 comprises no more than 25 wt% MCT, 20 wt% MCT, 15 wt% MCT, 10 wt% MCT, 5 wt% MCT, 3 wt% MCT, or 1 wt% MCT.
  • a composition selected from compositions 1 ⁇ 115 comprises LCT.
  • the composition comprises LCT but not MCT.
  • the LCT is an oil.
  • a composition of Table 1 comprises no more than 25 wt% MCT, 20 wt% MCT, 15 wt% MCT, 10 wt% MCT, 5 wt% LCT, 3 wt% LCT, or 1 wt% LCT.
  • the composition comprises both MCT and LCT.
  • both the MCT and the LCT is an oil.
  • a composition of Table 1 comprises a total amount of combined MCT and LCT selected from: 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 11 wt%, 0 ⁇ 12 wt%,0 ⁇ 13 wt%, 0 ⁇ 14 wt%, 0 ⁇ 15 wt%, 0 ⁇ 16 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 5 wt%, 1 ⁇ 10 wt%, 1 ⁇ 20 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 5 ⁇ 11 wt%, 5 ⁇ 12 wt%, 5 ⁇ 13 wt%, 5 ⁇ 14 wt%, 5 ⁇ 15 wt%, 5 ⁇ 16 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 w
  • the first surfactant of a composition selected from 1 ⁇ 115 of Table 1 is D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS).
  • TPGS D ⁇ Tocopherol polyethylene glycol 1000 succinate
  • the second surfactant of a composition selected from one of the
  • compositions 1 ⁇ 115 of Table 1 is lauroyl macrogol 32 glycerides.
  • the first surfactant is D ⁇ Tocopherol
  • the second surfactant is lauroyl macrogol 32 glycerides.
  • the lauroyl macrogol 32 glycerides is GELUCIRE 44/14.
  • the first surfactant of a composition selected from 1 ⁇ 115 of Table 1 is polysorbate 80 and the second surfactant is polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • PEG polyethylene glycol
  • Kolliphor RH40 hydrogenated castor oil
  • a total amount of surfactant selected from: 0 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 45 ⁇ 55 wt%, 45 ⁇ 65 wt%, 46 ⁇ 65 wt%, 47 ⁇ 65 wt%, 48 ⁇ 65 wt%, 49 ⁇ 65 wt%, 50 ⁇ 65 wt%, 51 ⁇ 65 wt%, 52 ⁇ 65 wt%, 53 ⁇ 65 wt%, 54 ⁇ 65 wt%, 55 ⁇ 65 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%, 65 ⁇ 70 wt%, 70 ⁇ 75 wt%, 75 ⁇ 80 wt%, 80 ⁇ 85 wt
  • the invention provides a composition comprising: an active ingredient; and
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, the active ingredient is selected from a cannabinoid or cannabinoid extract. In a further embodiment, the composition further comprises a medium ⁇ chain triglyceride (MCT) or long ⁇ chain triglyceride (LCT). In a further embodiment, the MCT or LCT is an oil.
  • MCT medium ⁇ chain triglyceride
  • LCT long ⁇ chain triglyceride
  • composition comprises:
  • At least one surfactant at least one surfactant; and, optionally,
  • compositions in Table 2 wherein the wt% of the active ingredient, the surfactant, and the MCT and/or LCT is selected from one of the compositions in Table 2 below.
  • Each of the compositions in Table 2 is an individual embodiment of the present invention.
  • At least one active ingredient of any one composition selected from 116 ⁇ 273 of Table 2 is a cannabinoid, cannabinoid extract, terpene, or terpene extract. In further embodiments, at least one active ingredient is a cannabinoid. In further embodiments, at least one active ingredient is a cannabinoid extract. In further
  • At least one active ingredient is a terpene. In further embodiments, at least one active ingredient is a terpene extract.
  • a composition selected from one of the compositions from 116 ⁇ 273 of Table 2 is a non ⁇ aqueous composition.
  • a composition selected from one of the compositions from 116 ⁇ 273 of Table 2 is a solid or semi ⁇ solid composition.
  • a composition of Table 2 where permissible, comprises: 0.01 ⁇ 0.1 wt%, 0.1 ⁇ 1 wt%, 1 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 3 wt%, 2.5 ⁇ 5 wt%, 3 ⁇ 8 wt%, 5.7.5 wt%, 5 ⁇ 10 wt%, 7.5 ⁇ 10 wt%, 7.5 ⁇ 15 wt%, 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, 9 ⁇ 11 wt%, more than 8 wt%, more than 10 wt%, 10 ⁇ 12.5 wt%, 12.5 ⁇ 15 wt%, 10 ⁇ 15 wt%, 10 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, or >50 wt% of an active ingredient(s), preferably comprising a cannabinoid or cannabinoid extract.
  • an active ingredient(s) preferably comprising
  • a composition selected from one of the compositions from 116 ⁇ 273 of Table 2 comprises: 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, 9 ⁇ 11 wt%, more than 8 wt%, more than 10 wt%, or 10 ⁇ 15 wt% of at least one active ingredient, e.g., a cannabinoid or cannabinoid extract.
  • a composition selected from one of the compositions from 1 ⁇ 213, 227, 228, and 237 ⁇ 255 of Table 2 comprises 1 ⁇ 5 wt%, 3 ⁇ 8%, or 8 ⁇ 12 wt% of at least one active ingredient, e.g., a cannabinoid or cannabinoid extract.
  • the cannabinoid extract comprises a cannabinoid(s) in an amount selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, 90 ⁇ 95 wt%, or >99 wt% cannabinoids.
  • the total concentration of the active ingredient(s), e.g., cannabinoid(s), in a composition selected from 116 ⁇ 273 of Table 2 is 1 ⁇ 200 mg/mL.
  • cannabinoid(s), in a composition selected from 116 ⁇ 273 of Table 2 is selected from: 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, or 150 ⁇ 200 mg/mL.
  • the total concentration of the active ingredient(s), e.g., cannabinoid(s), in a composition selected from one of the compositions from 116 ⁇ 273 of Table 2 is ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL.
  • a composition selected from one of the compositions from 116 ⁇ 273 of Table 2 contains the active ingredient(s), e.g., cannabinoid(s), in an amount selected from: 0.25 ⁇ 1 mg, 0.5 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5 ⁇ 7.5 mg, 7.5 ⁇ 10 mg, 10 ⁇ 12.5 mg, 12.5 ⁇ 15 mg, 15 ⁇ 20mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, or 70 ⁇ 75 mg.
  • the cannabinoid is THC.
  • the cannabinoids are THC and CBD.
  • a composition selected from 116 ⁇ 273 of Table 2 contains the active ingredient(s), e.g., cannabinoid(s), in an amount selected from: 0.25 ⁇ 1 mg, 0.5 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5 ⁇ 7.5 mg, 7.5 ⁇ 10 mg, 10 ⁇ 12.5 mg, 12.5 ⁇ 15 mg, 15 ⁇ 20mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇
  • the surfactant in a composition selected from compositions 116 ⁇ 273 of Table 2 is polysorbate 80, polysorbate 80 (polyoxyethylene (20) sorbitan monooleate, E433) and polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40), or polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40).
  • the surfactant in a composition selected from compositions 116 ⁇ 273 of Table 2 is polyoxyethylene (10) oleyl ether (e.g., BRIJ O10).
  • the surfactant in a composition selected from compositions 116 ⁇ 273 of Table 2 is macrogol 15
  • a composition of Table 2 where permissible, comprises a total amount of surfactant selected from: 0 ⁇ 2.5 wt%, 2.5 ⁇ 5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 25 wt%, 25 ⁇ 30 wt%, 30 ⁇ 35 wt%, 35 ⁇ 40 wt%, 40 ⁇ 45 wt%, 45 ⁇ 50 wt%, 45 ⁇ 55 wt%, 45 ⁇ 65 wt%, 46 ⁇ 65 wt%, 47 ⁇ 65 wt%, 48 ⁇ 65 wt%, 49 ⁇ 65 wt%, 50 ⁇ 65 wt%, 51 ⁇ 65 wt%, 52 ⁇ 65 wt%, 53 ⁇ 65 wt%, 54 ⁇ 65 wt%, 55 ⁇ 65 wt%, 50 ⁇ 55 wt%, 55 ⁇ 60 wt%, 60 ⁇ 65 wt%,
  • a composition of Table 2 comprises no more than 25 wt%, 20 wt%, 15 wt%, 10 wt%, 5 wt%, 3 wt%, or 1 wt% MCT.
  • the MCT is an oil.
  • the composition comprises no MCT.
  • a composition of Table 2 comprises no more than 25 wt%, 20 wt%, 15 wt%, 10 wt%, 5 wt%, 3 wt%, or 1 wt% LCT.
  • the LCT is an oil.
  • the composition comprises no LCT.
  • the composition comprises both MCT and LCT.
  • composition of Table 2 comprises no more than 25 wt%, 20 wt%, 15 wt%, 10 wt%, 5 wt%, 3 wt%, or 1 wt% combined MCT and LCT.
  • both the MCT and the LCT are an oil.
  • a composition of Table 2 wherein permissible, comprises a total amount of combined MCT and LCT selected from: 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 11 wt%, 0 ⁇ 12 wt%,0 ⁇ 13 wt%, 0 ⁇ 14 wt%, 0 ⁇ 15 wt%, 0 ⁇ 16 wt%, 0.5 ⁇ 1 wt%, 1 ⁇ 2 wt%, 1 ⁇ 2.5 wt%, 1 ⁇ 5 wt%, 1 ⁇ 10 wt%, 1 ⁇ 20 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 5 ⁇ 11 wt%, 5 ⁇ 12 wt%, 5 ⁇ 13 wt%, 5 ⁇ 14 wt%, 5 ⁇ 15 wt%, 5 ⁇ 16 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 w
  • the medium chain triglycerides (MCT) of the present invention are triglycerides whose fatty acids have an aliphatic tail of 6–12 carbon atoms.
  • the MCT may be a single MCT or a mix of MCT.
  • the MCT is formed from fatty acids having from C6 to C8, C8 to C10, C10 to C12, or C8 to C12 carbon atoms.
  • the fatty acids of the MCT may be saturated, mono ⁇ unsaturated, and/or poly ⁇ unsaturated fatty acids. In one embodiment 80 to 100 % of the medium chain fatty acids are saturated, 0 to 10 % are monounsaturated, and 0 to 5 % are polyunsaturated.
  • Preferred medium chain fatty acids include caproic acid, caprylic acid, capric acid, and mixtures thereof.
  • An oil comprising MCT may comprise at least 5 wt% medium chain triglycerides, e.g., coconut oil, or palm kernel oil.
  • the oil comprising an MCT is coconut oil.
  • MCT may be in the form of oil that is enriched or fractionated to increase the concentration of medium chain triglycerides.
  • the MCT is fractionated coconut oil (e.g., glyceryl tricaprylate or NATURE’S OIL MCT).
  • Medium chain triglycerides may also be formed by esterifying glycerol with mixtures of C6 ⁇ C12 fatty acids, e.g., C8 ⁇ C10 fatty acids such as caprylic (C:8) and capric (C:10) fatty acids fractionated from coconut or palm kernel oils.
  • C6 ⁇ C12 fatty acids e.g., C8 ⁇ C10 fatty acids such as caprylic (C:8) and capric (C:10) fatty acids fractionated from coconut or palm kernel oils.
  • the long chain triglycerides (LCT) of the present invention are triglycerides whose fatty acids have an aliphatic tail of 13 ⁇ 24 carbon atoms.
  • the LCT may be a single LCT or a mix of MCT.
  • the LCT is formed from long chain fatty having from C14 to C16, C16 to C18, C18 to C20, C14 to C20, or C20 to C24 carbon atoms.
  • the fatty acids of the LCT may be saturated, mono ⁇ unsaturated, and poly ⁇ unsaturated fatty acids. In one embodiment 5 to 25 % of the long chain fatty acids are saturated, 15 to 80 % are
  • the oil comprising an LCT may comprise at least 5 wt% long chain triglycerides, e.g., olive oil, poppy seed, safflower, sunflower, corn, and soybean oils, sesame oil, or castor oil.
  • LCT may be in the form of oil that is enriched or fractionated to increase the concentration of long chain triglycerides. In one embodiment, the LCT is olive oil.
  • the oil comprising an MCT and/or LCT may be selected from the group consisting of borage oil, castor oil, coconut oil, cottonseed oil, soybean oil, safflower oil, sunflower oil, castor oil, corn oil, olive oil, palm oil, peanut oil, poppy seed oil, canola oil, hydrogenated soybean oil, hydrogenated vegetable oils, sesame oil, triolein, trilinolein, and trilinolenin.
  • the compositions of the present invention are preferably for oral administration.
  • emulsion refers to a colloidal dispersion of two immiscible liquids, for example, an oil and water (or other aqueous medium, e.g., a polar solvent, simulated gastric fluid, gastric fluid, simulated intestinal fluid, intestinal fluid), one of which is part of a continuous phase and the other of which is part of a dispersed phase.
  • Emulsions typically are stabilized by one or more surfactants and/or co ⁇ surfactants and/or emulsion stabilizers. Surfactants form an interfacial film between the oil and water phase of the emulsion, providing stability.
  • emulsions typically contain micelles that contain one or more surfactants surrounding a non ⁇ polar compound which is dispersed in the water phase.
  • emulsions e.g., oil ⁇ in ⁇ water emulsions
  • two immiscible liquids e.g., an oil and an aqueous medium, such as water
  • Emulsions can be used to disperse non ⁇ polar compounds in aqueous media.
  • the dispersed phase is an oil phase and the continuous phase is an aqueous (e.g., water) phase.
  • Some of the compositions of the present invention self ⁇ emulsify in aqueous media, e.g., water, gastric fluids or intestinal fluids, to form an oil ⁇ in ⁇ water emulsion.
  • surfactant refers to synthetic and naturally occurring amphiphilic molecules that have hydrophobic portion(s) and hydrophilic portion(s). Due to their amphiphilic (amphipathic) nature, surfactants typically can reduce the surface tension between two immiscible liquids, for example, the oil and water phases in an emulsion, stabilizing the emulsion. Surfactants can be characterized based on their relative amphiphilic molecules, for example, the oil and water phases in an emulsion, stabilizing the emulsion. Surfactants can be characterized based on their relative
  • hydrophobicity and/or hydrophilicity For example, relatively lipophilic surfactants are more soluble in fats, oils and waxes, and typically have HLB values less than or about 10, while relatively hydrophilic surfactants are more soluble in aqueous compositions, for example, water, and typically have HLB values greater than or about 10. Relatively amphiphilic surfactants are soluble in oil ⁇ and water ⁇ based liquids and typically have HLB values close to 10 or about 10.
  • HLB refers to a value that is used to index and describe a surfactant according to its relative hydrophobicity/hydrophilicity, relative to other surfactants.
  • a surfactant's HLB value is an indication of the molecular balance of the hydrophobic and hydrophilic portions of the surfactant, which is an amphipathic molecule.
  • micelle refers to aggregates formed by surfactants that typically form when a surfactant is present in an aqueous composition, typically when the surfactant is used at a concentration above the critical micelle concentration (CMC).
  • CMC critical micelle concentration
  • the hydrophilic portions of the surfactant molecules contact the aqueous or the water phase, while the hydrophobic portions form the core of the micelle, which can encapsulate non ⁇ polar ingredient(s), for example, a cannabinoid.
  • the composition of the present invention is self ⁇ emulsifying in an aqueous medium.
  • the composition forms a micellar dispersion in an aqueous medium.
  • the composition of the present invention further comprises an aqueous medium.
  • the aqueous medium is selected from a polar solvent, water, simulated gastric fluid, gastric fluid, simulated intestinal fluid, or intestinal fluid.
  • the surfactant is at a concentration that is greater than its critical micelle concentration (CMC).
  • the composition is a micellar dispersion.
  • the composition is an emulsion.
  • the emulsion is an oil ⁇ in ⁇ water emulsion.
  • a beverage additive product comprising a composition of the present invention.
  • a beverage additive composition can contain one or more active ingredients, e.g., an active ingredient(s) derived from a cannabis plant, such as, one or more cannabinoid(s), terpene(s) or any other active ingredient of cannabis plant extract.
  • the active ingredient(s) of the beverage additive can also be one or more cannabinoid(s), terpene(s) or any other active ingredient of cannabis plant extract that is/are derived synthetically.
  • the beverage additive comprises CBD, ethyl pyruvate, THC, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • the beverage additive may further contain a flavoring or flavoring agent(s), sweetener, or an edible carrier.
  • the beverage additive may be provided in liquid, semi ⁇ solid, or solid form.
  • the concentration of each active ingredient, independently, or total active ingredients (e.g., CBD and ethyl pyruvate) in the beverage additive may be selected from: ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL, 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, 150 ⁇ 200 mg/mL, 200 ⁇ 250 mg/mL, 250 ⁇ 300 mg/mL, 300 ⁇ 350 mg/mL, 350 ⁇ 400 mg/mL, 400 ⁇ 450 mg/mL, 450 ⁇ 500 mg/
  • the concentration of total active ingredients, e.g., cannabinoids, in the beverage additive is selected from ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇
  • the amount for each cannabinoid, independently, or total active cannabinoids in a dose/serving of the beverage additive is selected from: ⁇ 0.001 mg, 0.001 ⁇ 0.25 mg, or 0.25 ⁇ 1 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5 ⁇ 7.5 mg, 7.5 ⁇ 10 mg, 10 ⁇ 12.5 mg, 12.5 ⁇ 15 mg, 15 ⁇ 20mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 75 mg, 75 ⁇ 100 mg, 100 ⁇ 150 mg, 150 ⁇ 200 mg, or >200mg.
  • the total ethyl pyruvate in a dose/serving of the beverage additive is selected from: 50 ⁇ 75 mg, 75 ⁇ 100 mg, 100 ⁇ 150 mg, 150 ⁇ 200 mg, 200 ⁇ 250 mg, 250 ⁇ 300 mg, 300 ⁇ 350 mg, 350 ⁇ 400 mg, 400 ⁇ 450 mg, 450 ⁇ 500 mg, 500 ⁇ 550 mg, 100 ⁇ 200 mg,200 ⁇ 300 mg,30 ⁇ 400 mg, 400 ⁇ 500 mg, 600 ⁇ 700 mg, 700 ⁇ 800 mg, 800 ⁇ 900 mg, 900 ⁇ 1000 mg, 1.0 ⁇ 2.0 g, 2.0 ⁇ 3.0 g, 3.0 ⁇ 4.0 g, 4.0 ⁇ 5.0 g, 5.0 ⁇ 6.0 g, 6.0 ⁇ 7.0 g, 7.0 ⁇ 8.0 g, 8.0 ⁇ 9.0 g, 9.0 ⁇ 10 g, 10 ⁇ 11 g, 11 ⁇ 12 g, 12 ⁇ 12.5, or > 12.5 g.
  • the beverage additive Prior to ingestion, the beverage additive can be added to water or any drink of choice.
  • the dilution ratio of beverage additive:beverage will depend on the composition of the beverage additive and selection of beverage type.
  • the beverage additive is diluted from 1:1 ⁇ 10,000 (i.e., 1 part beverage additive to 1 ⁇ 10,000 parts beverage).
  • the ratio is 1:1,000 ⁇ 10,000, 1:750 ⁇ 1,000, 1:500 ⁇ 750, 1:250 ⁇ 500, 1:100 ⁇ 250, 1:75 ⁇ 100, 1:50 ⁇ 75, 1:25 ⁇ 50, 1:10 ⁇ 25, 1:7.5 ⁇ 10, 1:5 ⁇ 7.5, 1:2.5 ⁇ 5, 1:1 ⁇ 2.5, or 1:1.
  • the ratio beverage additive to beverage is 1:0.5 ⁇ 1.
  • the beverage additive is added to a beverage to provide an aqueous emulsion.
  • the aqueous emulsion is transparent.
  • aqueous emulsification may require mechanical input or agitation, such as shaking, mixing or stirring.
  • the organoleptic properties of the emulsion may vary.
  • high surfactant content beverage additives can form clear, transparent emulsions, while compositions containing oils can form more turbid, i.e., translucent or opaque emulsions.
  • the composition is a rapid dispersing formulation, forming a transparent emulsion
  • micellar dispersion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • the composition form a transparent dispersion or emulsion within 3 min, 90 sec or 60 sec at 20 degrees C.
  • the rapid dispersing formulation does not require agitation (e.g., shaking or stirring) to form a transparent emulsion within a time selected from: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 or 60, or 90 seconds, or within 2, 2.5, 3, 3.5, 4, 4.5, or 5 minutes after addition to an aqueous medium at a temperature selected from: 4 degrees, 20 degrees, 40 degrees, or 60 degrees C, wherein the final concentration of the composition in the aqueous medium is 0.1 wt%.
  • said emulsion or micellar dispersion is a thermodynamically stable, isotropic liquid.
  • the taste or flavor of the emulsion can vary with the composition, such as the exact content of active ingredient(s), surfactant(s), oil(s), flavoring agent(s), sweetener(s) and edible carrier(s). Due to high “solvent capacity” or “dilutability” of some compositions
  • the emulsion can retain its desirable particle size distribution upon ingestion and dilution in the gut. This can provide pharmacokinetic benefits, such as faster onset of action, increased bioavailability and reduced pharmacokinetic variability, e.g., reduced dependence of pharmacokinetics on digestion, and reduced food effects.
  • the beverage additive may be added to any beverage suitable for human
  • the invention includes a combination of a beverage additive and a beverage or a kit comprising the beverage additive and the beverage, wherein the beverage additive and the beverage are in separate containers.
  • the beverage additive and the beverage are separate compartments of a container. For example, where the beverage additive is contained in a compartment in a cap/closure of a container.
  • the invention provides for a method of making a cannabis plant ⁇ based beverage comprising a composition of the present invention, the method comprising the steps of: obtaining a beverage additive and a beverage; adding the beverage additive to the beverage; and mixing the combined beverage additive and beverage to form a cannabis plant based beverage.
  • the combined beverage is homogeneous.
  • the combined beverage is an emulsion.
  • the invention provides for a beverage comprising the
  • the beverage is an aqueous beverage.
  • the aqueous beverage is selected from water, coffee, tea, fruit juice (e.g., orange, apple, cranberry, pear, pineapple, currant, etc.), algae (e.g., blue ⁇ green algae), vegetable juice (e.g., carrot, tomato, wheat or other grass, mixed vegetable or mixed vegetable ⁇ fruit etc.), sports drinks, and carbonated drinks (etc. sparkling water, soda water, and soft drinks such as colas).
  • the beverage is a dairy based beverage.
  • the dairy based beverage is selected from milk and yogurt drinks (including beverages that comprise milk or yogurt).
  • the invention relates to a drinking straw for use with a beverage in a beverage container, wherein the drinking straw comprises a composition (e.g., cannabinoid composition) of the present invention (including a beverage additive).
  • the drinking straw comprises a compartment or an erodible surface within an interior portion of the straw that contains the composition of the present invention, e.g., cannabinoid composition.
  • the straw may further comprise a one ⁇ way valve that prevents the composition of the present invention, e.g., cannabinoid composition from entering the beverage container.
  • Examples of drinking straws of include those disclosed in United States patents US 5921955, US 8342422, US 6482451, and US 8980348; United States patent applications US 2012/0056008, US 2008/0181932, US 2004/0142958, and US
  • particle size refers herein to oil in water droplet diameter, or water in oil droplet diameter, in an emulsion.
  • the average particle size of the emulsion is in the range of about 50 nm to about 1000 nm, depending on the composition. In one embodiment, the average particle size is between 10 ⁇ 50 nm. In another embodiment, the average particle size is between 50 ⁇ 100 nm. In another embodiment, the average particle size is between 75 ⁇ 125 nm. In another embodiment, the average particle size is between 100 ⁇ 150 nm. In another embodiment, the average particle size is between 200 ⁇ 400 nm. In another embodiment, the average particle size is between 200 ⁇ 300 nm. In another embodiment, the average particle size is between 250 ⁇ 350 nm.
  • the average particle size is between 300 ⁇ 400 nm. In another embodiment, the average particle size is between 400 ⁇ 500 nm. In another embodiment, the average particle size is between 500 ⁇ 600 nm. In another embodiment, the average particle size is between 600 ⁇ 650 nm. In another embodiment, the average particle size is between 600 ⁇ 700 nm. In another embodiment, the average particle size is between 700 ⁇ 800 nm. In another embodiment, the average particle size is between 800 ⁇ 900 nm. In another embodiment, the average particle size is between 750 ⁇ 850 nm. In one embodiment, the average particle size is less than 500 nm. In another embodiment, the average particle size is less than 400 nm. In another embodiment, the average particle size is less than 300 nm.
  • the average particle size is less than 200 nm. In another embodiment, the average particle size is less than 150 nm. In another embodiment, the average particle size is less than 100 nm. In another embodiment, the average particle size is less than 50 nm.
  • chemically stable or “chemical stability” of a composition of the present invention refers to the ability of the composition and/or cannabinoid(s) in the composition to resist change in its chemical properties over time.
  • Chemical instability of a composition may be manifested by decrease in the amount of the active ingredient, e.g., cannabinoid, e.g., THC or CBD.
  • cannabinoid e.g., THC or CBD.
  • Chemical degradation of THC e.g., may occur due to conversion of TCH to cannabinol (CBN).
  • CBD cannabinol
  • Physical instability of an emulsion may be
  • Determination whether an emulsion has lost its physical stability may be carried out in any of the following techniques: measurement of particle size, light scattering, focused beam reflectance measurement, centrifugation, rheology or a combination thereof.
  • the composition is stable at room temperature (21 ⁇ 25 ⁇ C), for about 12 months at 25°C ⁇ 2°C/40% RH ⁇ 5% RH, with ⁇ 20% decrease, ⁇ 10% decrease preferably ⁇ 5% decrease, in active ingredient content, e.g., in cannabinoid content, e.g., total, THC or CBD, and no change on dispersion in 37°C water over the 12 months.
  • active ingredient content e.g., in cannabinoid content, e.g., total, THC or CBD
  • compositions as mentioned above, wherein the composition is stable at 5°C ⁇ 3°C/40% RH ⁇ 5% RH for about 6 months, preferably 12 months, more preferably about 24 months, with ⁇ 20% decrease, ⁇ 10% decrease, preferably ⁇ 5% decrease, in active ingredient, e.g., in cannabinoid content, e.g., total, THC or CBD, and no change on dispersion in 37°C water over the relevant time frame.
  • active ingredient e.g., in cannabinoid content, e.g., total, THC or CBD
  • compositions as mentioned above, wherein the composition is stable at about 40°C ⁇ 2°C/75% RH ⁇ 5% RH for about 2 months, preferably about 6 months, with ⁇ 20% decrease, ⁇ 10% decrease, preferably ⁇ 5% decrease, in active ingredient, e.g., in cannabinoid content and no change on dispersion in 37°C water over the relevant time frame.
  • Active ingredients of the present invention may be purchased, synthesized using well ⁇ known techniques, or extracted from a plant using well ⁇ known methods.
  • Terpenes e.g., may be extracted from a plant of the Cannabis genus, e.g., Cannabis sativa, Cannabis indica, Cannabis hybrid, or other, or from a plant that is not a member of the Cannabis genus, e.g., is not from Cannabis sativa, Cannabis indica, Cannabis hybrid, or other Cannabis species.
  • Phytocannabinoids and terpenes may be extracted as terpene blends or, in the case of a Cannabis species, as a cannabinoid or
  • cannabinoid/terpene blend The blends may be used directly or can be separated into individual or fewer components using distillation (e.g., short ⁇ path rotary distillation) or other techniques.
  • distillation e.g., short ⁇ path rotary distillation
  • the relative amount of each principal phytocannabinoid and/or terpene in the plant extract, e.g., cannabis extract, varies according to the cannabinoid and/or terpene profile and levels of the particular plants and methodology of extraction.
  • Extracts comprising terpenes e.g., extracts essentially free of cannabinoids, extracts that contain cannabinoids as a minor constituent, or extracts from a plant that is not a species of Cannabis (e.g., Cannabis sativa, Cannabis indica, Cannabis hybrid, or other), i.e., a non ⁇ Cannabis species, may be used individually or combined with one or more other active ingredients, e.g., cannabinoids or cannabinoid extracts.
  • cannabinoids e.g., cannabinoids or cannabinoid extracts.
  • Cannabinoids and/or terpenes may be obtained by separating resins from leaves or leaves and flowers of cannabis plants by solvent extraction. Extracts derived from cannabis plants include primary extracts prepared by such processes as, for example, maceration,
  • Solvent extraction may be carried out using a solvent that dissolves cannabinoids/cannabinoid acids, such as for example C1 to C5 alcohols (e.g. ethanol, methanol), C3 ⁇ C12 alkanes (e.g. hexane, butane or propane), Norflurane
  • Carbon dioxide provides another method to extract cannabinoid/terpene resins from cannabis plant material.
  • cannabinoid/terpenes from the plant matter resulting in a transparent, amber oil.
  • the extracts obtained by supercritical fluid extraction (SFE) may undergo a secondary extraction, e.g. an ethanolic precipitation, to remove non ⁇ cannabinoid/terpene materials.
  • SFE supercritical fluid extraction
  • a secondary extraction e.g. an ethanolic precipitation
  • light petroleum gas extraction using a LHBES (light hydrocarbon butane extraction system) 1300/C from Extractiontek Solutions is used to extract cannabinoids from cannabis plant material.
  • a modified extraction process consists of decarboxylating the starting concentrate at 300° F until fully converted and the bubbling stops. Once the oil is decarboxylated, it is run through the VTA ⁇ VKL 70 ⁇ 5 short path rotary distillation plant twice. The first run separates the heavy terpenes and lighter terpenes from the cannabinoids and waste material. The cannabinoids and waste are run through again with a higher vacuum and higher
  • the VTA ⁇ VKL 70 ⁇ 5 short path rotary distillation plant uses a top stirring rotary column to wipe incoming product into a thin film for better heat distribution and evaporation.
  • the inner condensing column is set to condense the cannabinoids into liquids.
  • the waste and cannabinoids are diverted into the two dispensing arms for collection into receiving vessels.
  • terpenes are collected in a receiving flask attached to the inline chiller on the plant.
  • the system (except for feed vessel) are under vacuum during the operation.
  • the vacuum for the first run should be between 0.5 ⁇ 0.7 mbar.
  • pressure should be between 0.5 ⁇ 0.07 mbar.
  • compositions and methods using of the present invention include a cannabinoid selected from the group consisting: of tetrahydrocannabinol, ⁇ 9 ⁇ tetrahydrocannabinol (THC), ⁇ 8 ⁇ tetrahydrocannabinol, a cannabis extract, tetrahydrocannabinolic acid (THCA), cannabigerolic acid (CBGA), cannabidiolic acid (CBDA), cannabinolic acid (CBNA), ⁇ 8 ⁇ tetrahydrocannabinol ⁇ DMH, ⁇ 9 ⁇ tetrahydrocannabinol propyl analogue (THCV), 11 ⁇ hydroxy ⁇ tetrahydrocannabinol, 11 ⁇ nor ⁇ 9 ⁇ carboxy ⁇ tetrahydrocannabinol, 5′ ⁇ azido ⁇ 8 ⁇
  • a cannabinoid selected from the group consisting: of tetrahydrocannabinol, ⁇ 9 ⁇ tetra
  • tetrahydrocannabinol AMG ⁇ 1, AMG ⁇ 3, AM411, AM708, AM836, AM855, AM919, AM926, AM938, cannabidiol (CBD), cannabivarin (CBV), tetrahydrocannabivarin (THCV),
  • CBDV cannabidivarin
  • CBCV cannabichromevarin
  • CBDV cannabigerovarin
  • CBDG cannabigerol monomethyl ether
  • CBDV cannabigerol monomethyl ether
  • CBDV cannabinol
  • CBN cannabinol
  • cannabichromene cannabichromene propyl analogue, cannabigerol (CBG), cannabicyclol (CBL), cannabielsoin (CBE), cannabinodiol (CBDL), and cannabitriol (CBTL), CP 47497, CP 55940, CP 55244, CP 50556, CT ⁇ 3 or IP ⁇ 751 (ajulemic acid), dimethylheptyl HHC, HU ⁇ 210, HU ⁇ 211, HU ⁇ 308, WIN 55212 ⁇ 2, desacetyl ⁇ L ⁇ nantradol, dexanabinol, JWH ⁇ 051, JWH ⁇ 133, levonantradol, L ⁇ 759633, nabilone, O ⁇ 1184, cannabicyclohexanol (CP ⁇ 47,497 C8
  • the composition comprises any one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty ⁇ one, twenty ⁇ two, twenty ⁇ three, twenty ⁇ four, twenty ⁇ five, or more of the above cannabinoids.
  • the cannabinoid is selected from the group consisting of THC, CBD, THCA, CBDA, CBV, THCV, CBDV, CBCV, CBGV, CBN, CBC, and CBDL.
  • the cannabinoid is selected from the group consisting of THC, CBD, THCA, and CBDA. In another embodiment, the cannabinoid is THC or CBD. In another embodiment, the THC is ⁇ 9 ⁇ THC or ⁇ 8 ⁇ THC. In another embodiment, the THC is ⁇ 9 ⁇ THC. In another embodiment, the THC is ⁇ 8 ⁇ THC.
  • the cannabinoid is in the form of a Cannabis sativa, Cannabis indica, or Cannabis hybrid extract.
  • the cannabis extract comprises ⁇ 9 THC.
  • the extract comprises CBD.
  • the cannabinoid is a synthetic cannabinoid, e.g., dronabinol.
  • a composition of the present invention comprises: 1 ⁇ 5 wt%, 5 ⁇ 10 wt%, more than 5 wt%, 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, more than 8 wt%, 9 ⁇ 11 wt%, more than 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, of a cannabinoid or cannabinoid extract.
  • the cannabinoid extract comprises 50 ⁇ 99 wt% cannabinoids. In another embodiment, the cannabinoid extract comprises >99 wt% total cannabinoids. In another embodiment, the cannabinoid extract comprises a total amount of cannabinoid(s) selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, or 90 ⁇ 95 wt% cannabinoids.
  • the total concentration of cannabinoid(s) in a composition of the present invention is 1 ⁇ 200 mg/mL. In further embodiments, the total concentration of cannabinoid(s) in a composition of the present invention is selected from: 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, or 150 ⁇ 200 mg/mL. In another embodiment, the total concentration of cannabinoid(s) in a composition of the present invention is ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL.
  • the concentration of each cannabinoid(s), e.g., ⁇ 9 THC, in a composition of the present invention is selected from: 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50
  • the cannabinoid(s) is selected from one or more of CBD, THC, THCA, CBDA, CBV, THCV, CBDV, CBCV, CBGV, CBN, CBC, or CBDL.
  • the concentration of at least one cannabinoid is selected from 0.1 ⁇ 25 mg/mL, 25 ⁇ 50 mg/mL, 40 ⁇ 80 mg/mL, 80 ⁇ 120 mg/mL, or >120 mg/ml.
  • the concentration of at least one cannabinoid, e.g., THC is selected from 0.1 ⁇ 1.0 mg/ml, 1.0 ⁇ 2.5 mg/ml, 2.5 ⁇ 5.0 mg/mL, 5.0 ⁇ 10 mg/mL, 10 ⁇ 25 mg/mL, or 25 ⁇ 50 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, or >100 mg/ml.
  • a composition of the present invention comprises: 1 ⁇ 5 wt%, 5 ⁇ 10 wt%, more than 5 wt%, 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, more than 8 wt%, 9 ⁇ 11 wt%, more than 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, of a CBD or CBD extract (i.e., a cannabinoid extract comprising CBD).
  • the CBD extract comprises 50 ⁇ 99 wt% CBD.
  • the CBD extract comprises >99 wt% total CBD.
  • the CBD extract comprises a total amount of CBD selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, or 90 ⁇ 95 wt% CBD.
  • a composition of the present invention comprises: 1 ⁇ 5 wt%, 5 ⁇ 10 wt%, more than 5 wt%, 8 ⁇ 15 wt%, 8 ⁇ 12 wt%, more than 8 wt%, 9 ⁇ 11 wt%, more than 10 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, 20 ⁇ 30 wt%, 30 ⁇ 40 wt%, 40 ⁇ 50 wt%, of a THC or THC extract (i.e., an extract comprising THC).
  • the THC extract comprises 50 ⁇ 99 wt% THC.
  • the THC extract comprises >99 wt% total THC.
  • the THC extract comprises a total amount of THC selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, or 90 ⁇ 95 wt% THC.
  • the present invention includes at one terpene selected from the group consisting of: alpha ⁇ pinene, valencene, myrcene, camphene, beta ⁇ pinene, citral, humulene, alpha ⁇ bisabolol, beta ⁇ caryophyllene, camphor, limonene, linalool, alpha ⁇ phellandrene, eucalyptol, terpineol, nerolidol, y ⁇ terpinene, terpinolele, gama ⁇ 3 ⁇ carene, pulegone, geraniol, ocimene, eugenol, p ⁇ cymene, ocimene, isopulegol, geranyl acetate, valencene, myrcene, cadinene, cedrane, citronellol, guaiene, dextro carvone, carvacrol, borneol, thymol,
  • the composition of the present invention comprises 0 ⁇ 50 wt% total terpene(s).
  • a composition of the present invention comprises a total amount of terpene(s) selected from: 0 ⁇ 0.1 wt%, 0 ⁇ 0.5 wt%, 0.5 ⁇ 1 wt%, 0 ⁇ 1 wt%, 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 25 wt %, 1 ⁇ 2 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 wt%, 15 ⁇ 20 wt%, or 20 ⁇ 25 wt%, or 25 ⁇ 50% wt% terpene(s).
  • the cannabinoid extract comprises a total amount of cannabinoid(s) and a total amount of terpene(s) selected from: 50 ⁇ 75 wt%, 50 ⁇ 99 wt%, 75 ⁇ 99 wt%, 75 ⁇ 95 wt%, 80 ⁇ 99 wt%, 85 ⁇ 99 wt%, 90 ⁇ 99 wt%, 85 ⁇ 95 wt%, 90 ⁇ 95 wt%, or >99 wt% cannabinoid(s); and 0 ⁇ 0.1 wt%, 0 ⁇ 0.5 wt%, 0.5 ⁇ 1 wt%, 0 ⁇ 1 wt%, 0 ⁇ 5 wt%, 0 ⁇ 10 wt%, 0 ⁇ 25 wt %, 1 ⁇ 2 wt%, 2 ⁇ 3 wt%, 3 ⁇ 4 wt%, 4 ⁇ 5 wt%, 5 ⁇ 7.5 wt%, 5 ⁇ 10 wt%, 10 ⁇ 12.5 wt%, 10 ⁇ 15 w
  • the terpenes and cannabinoids are co ⁇ extracted, i.e., extracted together. In another embodiment, some or all of the terpenes are extracted separately from the cannabinoids. In another embodiment, some or all of the terpenes are synthetic. In one embodiment, the total concentration of the terpene(s) in a composition of the present invention is selected from: 0.05 ⁇ 50 mg/mL, 0.05 ⁇ 0.1 mg/mL, 0.1 ⁇ 0.5 mg/mL, 0.5 ⁇ 1 mg/mL, 1 ⁇ 5 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 1 ⁇ 50
  • the total concentration of the terpene(s) in a composition of the present invention is selected from: ⁇ 0.001 mg/mL, 0.001 ⁇ 0.01 mg/mL, or 0.01 ⁇ 1mg/mL, 0.05 ⁇ 50 mg/mL, 0.05 ⁇ 0.1 mg/mL, 0.1 ⁇ 0.5 mg/mL, 0.5 ⁇ 1 mg/mL, 1 ⁇ 5 mg/mL, 1 ⁇ 10 mg/mL, 1 ⁇ 50 mg/mL, 1 ⁇ 100 mg/mL, 5 ⁇ 50 mg/mL, 10 ⁇ 50 mg/mL, 10 ⁇ 100 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 15 mg/mL, 15 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50 mg/mL, 40 ⁇ 60 mg/mL, 50 ⁇ 75 mg/mL, 75 ⁇ 100 mg/mL, 100 ⁇ 150 mg/mL, or 150 ⁇ 200 mg/mL, or >200 mg/ml.
  • the total concentration of the terpene(s) in a composition of the present invention is selected from: 0.05 ⁇ 50 mg/mL, 0.05 ⁇ 0.1 mg/mL, 0.1 ⁇ 0.5 mg/mL, 0.5 ⁇ 1 mg/mL, 1 ⁇ 5 mg/mL, 5 ⁇ 10 mg/mL, 10 ⁇ 20 mg/mL, 20 ⁇ 30 mg/mL, 30 ⁇ 40 mg/mL, 40 ⁇ 50
  • mg/mL 1 ⁇ 50 mg/mL, or 10 ⁇ 50 mg/mL.
  • the terpene in selected from any one, two, three, four, five, or all six of the terpenes selected from the group consisting of: myrcene, beta ⁇
  • said terpenes include any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0 ⁇ 2.0% any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0.3 ⁇ 0.5% any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0.3 ⁇ 0.5% of each of the following terpenes: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises: 0.25 ⁇ 0.45% beta ⁇ caryophyllene, 0 ⁇ 0.15 % linalool, 0.5 ⁇ 1.0% limonene, 0.75 ⁇ 1.5% alpha ⁇ pinene, and 0 ⁇ 0.05% eucalyptol.
  • said composition is a formulation selected from any one of A1 ⁇ A34 or any one of BA9 ⁇ BA25 (see Examples).
  • the composition comprises: 0 ⁇ 15% THC, 0 ⁇ 20% CBD, 0 ⁇ 50% ethyl pyruvate, 0 ⁇ 10% terpenes. In another embodiment, the composition comprises: 0 ⁇ 10% THC, 0 ⁇ 15% CBD, 0 ⁇ 50% ethyl pyruvate, 0 ⁇ 10% terpenes. In another embodiment, the composition comprises: 0 ⁇ 5% THC, 0 ⁇ 10% CBD, 0 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes.
  • the composition comprises: 0.05 ⁇ 5% THC, 0.5 ⁇ 10% CBD, 1 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes. In another embodiment, the composition comprises: 0.05 ⁇ 1% THC, 2.5 ⁇ 10% CBD, 1 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes. In another embodiment, the composition comprises: 0.1 ⁇ 0.5% THC, 4 ⁇ 7.5% CBD, 1.0 ⁇ 10 or 10 ⁇ 30% ethyl pyruvate, 1 ⁇ 2.5% terpenes. In another embodiment, said composition comprises 50 ⁇ 90% polysorbate 80. In another embodiment, said composition comprises 0 ⁇ 5% sweetener, e.g., sucralose.
  • said composition comprises: 0 ⁇ 7.0 % THC, 0 ⁇ 7.0 % CBD, 9 ⁇ 30% ethyl pyruvate, 1 ⁇ 5% terpenes, at least 59% polysorbate 80, and 0 ⁇ 5.0% sucralose.
  • said composition comprises 0.25 ⁇ 1.0 % THC, 4 ⁇ 9% CBD, 25 ⁇ 35 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 50 ⁇ 70 % polysorbate 80.
  • said composition comprises 0.25 ⁇ 0.75 % THC, 4 ⁇ 9% CBD, 7.5 ⁇ 12.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 70 ⁇ 85 % polysorbate 80.
  • said composition comprises 0 ⁇ 0.25 % THC, 3.5 ⁇ 9% CBD, 0.25 ⁇ 2.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 81.5 ⁇ 95.5 % polysorbate 80.
  • said composition comprises 0.4 ⁇ 0.6 % THC, 5.5 ⁇ 7.5% CBD, 7.5 ⁇ 12.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 75 ⁇ 82 % polysorbate 80.
  • said composition comprises 0.05 ⁇ 0.15 % THC, 4.0 ⁇ 6.0% CBD, 0.5 ⁇ 2.5 % ethyl pyruvate, 1.5 ⁇ 3.5 % terpenes, 0 ⁇ 5% sucralose, and 82 ⁇ 92 % polysorbate 80.
  • said composition comprises 0.4 ⁇ 0.6 % THC, 5.5 ⁇ 7.5% CBD, 27 ⁇ 32 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 55 ⁇ 65 % polysorbate 80.
  • the composition comprises: 0 ⁇ 15% THC, 0 ⁇ 20% CBD, 0 ⁇ 50% ethyl pyruvate, 0 ⁇ 10% terpenes. In another embodiment, the composition comprises: 0 ⁇ 10% THC, 0 ⁇ 15% CBD, 0 ⁇ 50% ethyl pyruvate, 0 ⁇ 10% terpenes. In another embodiment, the
  • composition comprises: 0 ⁇ 5% THC, 0 ⁇ 10% CBD, 0 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes. In another embodiment, the composition comprises: 0.05 ⁇ 5% THC, 0.5 ⁇ 10% CBD, 1 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes. In another embodiment, the composition comprises: 0.05 ⁇ 1% THC, 2.5 ⁇ 10% CBD, 1 ⁇ 40% ethyl pyruvate, 0 ⁇ 5% terpenes. In another embodiment, the composition comprises: 0.1 ⁇ 0.5% THC, 4 ⁇ 7.5% CBD, 1.0 ⁇ 10 or 10 ⁇ 30% ethyl pyruvate, 1 ⁇ 2.5% terpenes. In another embodiment, said composition comprises 50 ⁇ 90% polysorbate 80. In another embodiment, said composition comprises 0 ⁇ 5% sweetener, e.g., sucralose.
  • said composition comprises: 0 ⁇ 7.0 % THC, 0 ⁇ 7.0 % CBD, 9 ⁇ 30% ethyl pyruvate, 1 ⁇ 5% terpenes, at least 59% polysorbate 80, and 0 ⁇ 5.0% sucralose.
  • said composition comprises 0.25 ⁇ 1.0 % THC, 4 ⁇ 9% CBD, 25 ⁇ 35 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 50 ⁇ 70 % polysorbate 80.
  • said composition comprises 0.25 ⁇ 0.75 % THC, 4 ⁇ 9% CBD, 7.5 ⁇ 12.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 70 ⁇ 85 % polysorbate 80.
  • said composition comprises 0 ⁇ 0.25 % THC, 3.5 ⁇ 9% CBD, 0.25 ⁇ 2.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 81.5 ⁇ 95.5 % polysorbate 80.
  • said composition comprises 0.4 ⁇ 0.6 % THC, 5.5 ⁇ 7.5% CBD, 7.5 ⁇ 12.5 % ethyl pyruvate, 1 ⁇ 3 % terpenes, 0 ⁇ 5% sucralose, and 75 ⁇ 82 % polysorbate 80.
  • said composition comprises 0.05 ⁇ 0.15 % THC, 4.0 ⁇ 6.0% CBD, 0.5 ⁇ 2.5 % ethyl pyruvate, 1.5 ⁇ 3.5 % terpenes, 0 ⁇ 5% sucralose, and 82 ⁇ 92 % polysorbate 80.
  • said composition comprises 0.4 ⁇ 0.6 % THC, 5.5 ⁇ 7.5% CBD, 27 ⁇ 32 % ethyl
  • the terpene in selected from any one, two, three, four, five, or all six of the terpenes selected from the group consisting of: myrcene, beta ⁇
  • said terpenes include any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0 ⁇ 2.0% any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0.3 ⁇ 0.5% any one, two, three, four, or all five terpenes selected from the group consisting of: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises 0.3 ⁇ 0.5% of each of the following terpenes: beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • said formulation comprises: 0.25 ⁇ 0.45% beta ⁇ caryophyllene, 0 ⁇ 0.15 % linalool, 0.5 ⁇ 1.0% limonene, 0.75 ⁇ 1.5% alpha ⁇ pinene, and 0 ⁇ 0.05% eucalyptol.
  • a composition of the present invention may further comprise, inter alia, an additional surfactant, antioxidant, viscosity modifying agent, cytochrome P450 metabolic inhibitor, P ⁇ GP efflux inhibitor, or semi ⁇ solid inducer.
  • Preferred antioxidants include ascorbyl palmitate, butylated hydroxy anisole, butylated hydroxy toluene, propyl gallate, ⁇ tocopherol, ⁇ tocopherol, and mixed tocopherols.
  • the composition of the present invention further comprises an antioxidant(s) in the range of about 0.01% w/v to about 0.1% w/v.
  • Viscosity modifying agents include unmodified starches, pregelatinized starches, crosslinked starches, guar gum, xanthan gum, acacia, tragacanth, carrageenans, alginates, chitosan, precipitated calcium carbonate (PCC), polyvinyl pyrrolidone, polyethylene oxide, polyethylene glycols (PEG), polycarbophils, EUDRAGIT® series polymers (E, L, S, RL, RS, NE), hydroxymethylpropyl cellulose (HPMC), hydroxyethylcellulose (HEC),
  • HPC hydroxypropylmethylcelluose
  • Na ⁇ CMC carboxymethylcellose sodium
  • ethylcellulose cellulose acetate
  • cellulose acetate phthalate polyvinylacetate/polyvinylpyrrolidone
  • PVA/PVP polyvinylacetate/polyvinylpyrrolidone
  • PVA/PEG graft copolymer hydrogenated vegetable oils, polyglycolized esters of fatty acids, carnauba wax, stearyl alcohol, and beeswax, polyvinyl caprolactam ⁇ polyvinyl acetate ⁇ polyethylene glycol graft co ⁇ polymer, and combinations thereof.
  • Cytochrome P450 inhibitors include an agent that inhibits pre ⁇ systemic hepatic first pass metabolism, e.g., d ⁇ tocopheryl polyethylene glycol 1000 succinate, anise oil, cinnamon oil, coriander oil, grapefruit oil, lemon oil, orange oil, peppermint oil, ascorbyl palmitate, propyl gallate, and combinations thereof.
  • PGP efflux inhibitors includes an agent that inhibits PGP induced cellular efflux mechanisms, e.g., polyethoxylated castor oil derivatives, polyoxyethylene sorbitan
  • a composition of the present invention may comprise a semi ⁇ solid inducer, e.g., colloidal silicon dioxide, granulated fumed silicas, precipitated silicas, amorphous silica gel, magnesium aluminum silicates, sodium magnesium aluminum silicates, microcrystalline cellulose, talc, dicalcium phosphate anhydrous, isomaltose and combinations thereof.
  • a semi ⁇ solid inducer e.g., colloidal silicon dioxide, granulated fumed silicas, precipitated silicas, amorphous silica gel, magnesium aluminum silicates, sodium magnesium aluminum silicates, microcrystalline cellulose, talc, dicalcium phosphate anhydrous, isomaltose and combinations thereof.
  • a composition of the present invention may further comprise an additional co ⁇ surfactant(s) to improve the emulsification of the provided compositions.
  • co ⁇ surfactants include glycerol, sodium stearate, potassium laurate, sodium dodecyl sulfate, sodium sulfosuccinate, polyglycol, fatty acid esters, quaternary ammonium salts, amine hydrochlorides and combination thereof.
  • a composition may comprise chelating agents in a final range of about 0.01% to about 0.5% w/v.
  • chelating agents include ethylenediaminetetraacetic acid (EDTA), phosphoric acid, polyphosphates, polysaccharides, citric acid and combinations thereof.
  • a composition may also additionally comprise inactive ingredients selected from a group consisting of antiadherents, binders, coatings, disintegrants, flavours, colours, lubricants, glidants, sorbents, preservatives, sweeteners, edible carriers, and combinations thereof.
  • a composition may further comprise a pH adjusting agent, e.g., disodium hydrogen phosphate, sodium acetate, sodium bicarbonate, sodium phosphate tribasic, dipotassium hydrogen phosphate, phosphoric acid, acetic acid, lactic acid, fumaric acid, adipic acid, malic acid, tartaric acid, citric acid, hydrochloric acid, sulfuric acid, salts thereof, and combinations thereof.
  • a pH adjusting agent e.g., disodium hydrogen phosphate, sodium acetate, sodium bicarbonate, sodium phosphate tribasic, dipotassium hydrogen phosphate, phosphoric acid, acetic acid, lactic acid, fumaric acid, adipic acid, malic acid, tartaric acid, citric acid, hydrochloric acid, sulfuric acid, salts thereof, and combinations thereof.
  • a pH adjusting agent e.g., disodium hydrogen phosphate, sodium acetate, sodium bicarbonate, sodium phosphate tribasic,
  • a composition may additionally comprise an osmotic agent, e.g., glycerin, glucose, sucrose, sorbitol, sodium phosphate and combinations thereof.
  • an osmotic agent e.g., glycerin, glucose, sucrose, sorbitol, sodium phosphate and combinations thereof.
  • a composition may further comprise a sweetener, flavoring and/or taste ⁇ masking agent, e.g., glucose, fructose, sucrose, sorbitol, sucralose, saccharin sodium, aspartame, neotame, acesulfame potassium, stevioside, sodium chloride, D ⁇ limonene, citric acid, xylitol and combinations thereof.
  • the sweetener is selected from one or more of: acesulfame potassium, advantame, aspartame, neotame, saccharin, sucralose, stevia, glucose, fructose, sucrose, sorbitol, or xylitol.
  • the sweetener is sucralose.
  • a composition may also further comprise preservatives, e.g., methylparabens,
  • ethylparabens propylparabens, butylparabens, sorbic acid, acetic acid, propionic acid, sulfites, nitrites, sodium sorbate, potassium sorbate, calcium sorbate, benzoic acid, sodium benzonate, potassium benzonate, calcium benzonate, sodium metabisulfite, propylene glycol, benzaldehyde, butylated hydroxytoluene, butylated hydroxyanisole, formaldehyde donors, essential oils, monoglyceride, and combinations thereof.
  • a composition of the present invention may be formulated, e.g., as a delayed release, sustained release, pulsatile release, immediate release, fast ⁇ disintegrating (e.g., orally disintegrating), or other release dosage form.
  • the dosage form may include drug polymer conjugates, microencapsulation, controlled ⁇ release tablet/capsule coating, pH or other stimuli sensitive materials, enteric coated, or combinations thereof.
  • the invention provides for an edible product comprising a composition of the present invention.
  • Edible products include a lozenge, candy (including hard candies/boiled sweets, lollipop, gummy candy, candy bar, etc.), chocolates, brownie, cookie, trail bar, crackers, dissolving strip, mint, pastry, bread, etc. Further included is chewing gum, although the base gum is not consumed.
  • a composition of present invention is a pharmaceutical composition.
  • the composition/pharmaceutical composition is a unit dose of the composition/pharmaceutical composition.
  • the unit dose is for oral administration, i.e., an oral unit dosage form.
  • the unit dose is for sublingual (held under the tongue) or buccal (held between the cheek and gum) administration, i.e., a sublingual or buccal unit dosage form.
  • the unit dose is a liquid, solid, or semi ⁇ solid.
  • the unit dose may be in the form of a syrup, drops, micellar dispersion, emulsion, solution, suspension, tablet, bolus, troche, tincture, oral/buccal/sublingual spray, lozenge, dissolving strip, or capsule.
  • the capsule is a hard gelatin
  • the unit dose is a hard gelatin capsule. In a further embodiment, the unit dose is a soft gelatin capsule.
  • the syrup, drops, micellar dispersion, emulsion, solution, suspension, tablet, bolus, troche, tincture, spray, lozenge, or capsule is an oral unit dosage form and, in another embodiment, the same is a sublingual or buccal unit dosage form.
  • compositions of the present invention for any particular subject may depend upon a variety of factors including: the subject’s age, body weight, general health, and gender; the time of administration; the combination of actives; the severity of the particular disease, disorder, or condition being treated; and the form or route of
  • Treatment dosages generally may be titrated to optimize safety and efficacy.
  • a suitable dose for internal administration is generally in the range of 0.01 to 150 mg/kg per day, including 0.1 ⁇ 100 mg/kg, 0.1 ⁇ 50 mg/kg, and 0.1 ⁇ 10 mg/kg. Determining an appropriate dose can be performed by one of skill in the art.
  • the actives ingredients may be administered as a fixed dose combination or as
  • the actives ingredients may be administered as a single dosage form or as multiple dosage forms.
  • the active ingredients may be administered concurrently or sequentially (either at a same or different time).
  • the unit dose comprises about 0.25 ⁇ 100 mg of active ingredient, e.g., cannabinoid or cannabinoid extract. In another embodiment, the unit dose comprises about 0.25 ⁇ 0.5 mg of active ingredient, e.g., cannabinoid or cannabinoid extract. In another embodiment, the unit dose comprises about 0.5 ⁇ 1 mg of active ingredient, e.g., cannabinoid
  • the unit dose comprises about 1 ⁇ 2.5 mg of active ingredient, e.g., cannabinoid or cannabinoid extract. In another embodiment, the unit dose comprises about 2.5 ⁇ 5 mg of active ingredient, e.g., cannabinoid or cannabinoid extract. In another embodiment, the unit dose comprises about 5 ⁇ 7.5 mg of active
  • cannabinoid e.g., cannabinoid or cannabinoid extract.
  • the unit dose comprises about 0.5 ⁇ 15 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 0.5 ⁇ 2.5 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 2.5 ⁇ 1 mg of active
  • the unit dose comprises about 2.5 ⁇ 5 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 5 ⁇ 7.5 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 5 ⁇ 10 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 5 ⁇ 15 mg of active
  • the unit dose comprises about 7.5 ⁇ 10 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 10 ⁇ 12.5 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 12.5 ⁇ 15 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 15 ⁇ 20 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 20 ⁇ 30 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 30 ⁇ 40 mg of active
  • the unit dose comprises about 40 ⁇ 50 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 50 ⁇ 60 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 60 ⁇ 70 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 70 ⁇ 75 mg of active
  • the unit dose comprises about 70 ⁇ 80 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 80 ⁇ 90 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 90 ⁇ 100 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 100 ⁇ 150 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 150 ⁇ 200 mg of active ingredient, e.g., cannabinoid(s) or cannabinoid extract. In another embodiment, the unit dose comprises about 0.5, about 1, about 5, about
  • the cannabinoid is THC.
  • the cannabinoid is CDB.
  • the cannabinoids are THC and CBD.
  • the unit dose comprises an amount of one or more cannabinoids, wherein the amount of each cannabinoid, independently, or total
  • cannabinoids (if specified) is selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more cannabinoids is CBD, THC, CBN, CBG, CBC, THCA, CBDA, and THCV
  • said unit dose comprises an amount of said CBD, THC, CBN, CBG, CBC, THCA, CBDA, and THCV, each independently selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more cannabinoids is CBD and THC
  • said unit dose comprises an amount of said CBD and THC independently selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more cannabinoids is delta ⁇ 8 ⁇ THC and delta ⁇ 9 ⁇ THC
  • said unit dose comprises an amount of said delta ⁇ 8 ⁇ THC and delta ⁇ 9 ⁇ THC independently selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, and >100 mg.
  • the unit dose comprises an amount of one or more terpenes, independently, or total terpenes selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more terpenes is selected from: myrcene, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol
  • said unit dose comprises an amount of said myrcene, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol, each independently selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15
  • said comprises the step of administering a therapeutically
  • cannabinoids and/or ethyl pyruvate, and/or one or more terpenes (including
  • said active ingredients comprise one or more
  • said active ingredients comprise ethyl pyruvate and one or more terpenes. In another embodiment, said active ingredients comprise one or more cannabinoids and one or more terpenes. In another embodiment, said active ingredients comprise one or more cannabinoids, ethyl pyruvate, and one or more terpenes. In another embodiment, said active ingredients comprise at least two
  • said active ingredients comprise at least two
  • said active ingredients comprise one or more
  • cannabinoids and at least one other active ingredient ethyl pyruvate and at least one other active ingredient; or one or more terpenes and at least one other active ingredient.
  • the one or more cannabinoids is selected from the group consisting of: CBD, THC, CBN, CBG, CBC, THCA, CBDA, and THCV.
  • the one or more cannabinoids is CBD, THC, or CBD and THC.
  • the active ingredients comprise: one or more cannabinoids selected from CBD, THC, or CBD and THC; and ethyl pyruvate.
  • the active ingredients comprise one or more terpenes.
  • the terpene in selected from any one, two, three, four, five, or all six of the terpenes selected from the group consisting of: myrcene, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol.
  • the one or more terpenes is any one, two, three, four, or all five selected from beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, or eucalyptol.
  • the active ingredients comprise: one or more cannabinoids selected from CBD, THC, or CBD and THC; ethyl
  • pyruvate pyruvate
  • terpenes selected from any one, two, three, four, five, or all six of: myrcene, beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, or eucalyptol.
  • the unit dose comprises an amount of ethyl pyruvate selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.5 ⁇ 1.0 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 5.0 ⁇ 75 mg, 5.0 ⁇ 10 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, and 1 ⁇ 100 mg 50 ⁇ 100 mg, 100 ⁇ 200 mg, 200 ⁇ 300 mg, 300 ⁇ 400 mg, 500 ⁇ 600 mg, 600 ⁇
  • the unit dose comprises:
  • THC/THC extract 0 ⁇ 10 mg
  • CBD/CBD extract 0 ⁇ 50 mg
  • terpenes 0 ⁇ 20 mg total or 0 ⁇ 3.5 mg/terpene.
  • the unit dose comprises:
  • an amount of one or more cannabinoids the amount of each cannabinoid independently selected from the group consisting of: none, trace amount, 0.01 ⁇ 0.05 mg, 0.05 ⁇ 0.1 mg, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg;
  • an amount of ethyl pyruvate selected from the group consisting of: none, trace amount, 0.1 ⁇ 0.5 mg, 0.5 ⁇ 1.0 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 5.0 ⁇ 75 mg, 5.0 ⁇ 10 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, and 1 ⁇ 100 mg 50 ⁇ 100 mg, 100 ⁇ 200 mg, 200 ⁇ 300 mg, 300 ⁇ 400 mg, 500 ⁇ 600 mg, 600 ⁇ 700 mg, 700 ⁇ 800 mg, 800 ⁇ 900 mg, 900 ⁇ 1000 mg; 1.0 ⁇ 2.0 g, 2.0 ⁇ 3.0 g, 3.0 ⁇ 4.0 g, 4.0 ⁇ 5.0 g, 5.0 ⁇ 6.0 g, 6.0 ⁇ 7.0 g, 7.0 ⁇ 8.0 g, 8.0 ⁇ 9.0 g, 9.0 ⁇ 10 g
  • terpenes each independently, or total terpenes selected from the group consisting of: none, trace amount, none, trace amount, 0.01 ⁇ 0.05 mg, 0.05 ⁇ 0.1 mg, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more cannabinoids is CBD, THC, CBN, CBG, CBC, THCA, CBDA, and THCV
  • said unit dose comprises an amount of said CBD, THC, CBN, CBG, CBC, THCA, CBDA, and THCV, each independently selected from the group
  • said one or more cannabinoids is CBD and THC
  • said unit dose comprises an amount of said CBD and THC each independently selected from the group consisting of: none, trace amount, none, trace amount, 0.01 ⁇ 0.05 mg, 0.05 ⁇ 0.1 mg, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, and >200 mg.
  • said one or more cannabinoids is delta ⁇ 8 ⁇ THC and delta ⁇ 9 ⁇ THC
  • said unit dose comprises an amount of said delta ⁇ 8 ⁇ THC and delta ⁇ 9 ⁇ THC each independently selected from the group consisting of: none, trace amount, none, trace
  • said one or more terpenes is beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol
  • said unit dose comprises an amount of said beta ⁇ caryophyllene, linalool, limonene, alpha ⁇ pinene, and eucalyptol, each independently selected from the group consisting of: none, trace amount, none, trace amount, 0.01 ⁇ 0.05 mg, 0.05 ⁇ 0.1 mg, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg,
  • said unit dose further comprises one or more additional active ingredients selected from: one or more non ⁇ opioid analgesic/ anti ⁇ inflammatory drug, one or more anti ⁇ migraine drug, one or more anti ⁇ emetic, one or more anti ⁇ Parkinson disease drug, one or more anti ⁇ MS disease drug, one or more anti ⁇ spasticity drug, one or more nutraceutical, one or more corticosteroid, or a combination thereof.
  • additional active ingredients selected from: one or more non ⁇ opioid analgesic/ anti ⁇ inflammatory drug, one or more anti ⁇ migraine drug, one or more anti ⁇ emetic, one or more anti ⁇ Parkinson disease drug, one or more anti ⁇ MS disease drug, one or more anti ⁇ spasticity drug, one or more nutraceutical, one or more corticosteroid, or a combination thereof.
  • said unit dose comprises an amount of each of said one or more additional active ingredients that is independently selected from the group consisting of: 0.001 ⁇ 0.01 mg, 0.01 ⁇ 0.05 mg, 0.05 ⁇ 0.1 mg, 0.1 ⁇ 0.5 mg, 0.25 ⁇ 1 mg, 0.5 ⁇ 15 mg, 0.5 ⁇ 2.5 mg, 1.0 ⁇ 2.5 mg, 2.5 ⁇ 5 mg, 5.0 ⁇ 7.5 mg, 5.0 ⁇ 10 mg, 1.0 ⁇ 25 mg, 25 ⁇ 50 mg, 50 ⁇ 75 mg, 75 ⁇ 100 mg, 10 ⁇ 20 mg, 10 ⁇ 15 mg, and 15 ⁇ 20 mg, 20 ⁇ 30 mg, 30 ⁇ 40 mg, 40 ⁇ 50 mg, 50 ⁇ 60 mg, 60 ⁇ 70 mg, 70 ⁇ 80 mg, 80 ⁇ 90 mg, 90 ⁇ 100 mg, 1 ⁇ 100 mg, 100 ⁇ 125 mg, 125 ⁇ 150 mg, 150 ⁇ 175 mg, 175 ⁇ 200 mg, 200 ⁇ 300 mg, 300 ⁇ 400 mg, 500 ⁇ 600 mg, 600 ⁇ 700 mg, 700 ⁇ 800 mg, 800 ⁇ 900 mg, 900 ⁇ 1000 mg; 1.0 ⁇ 2.0 g, 2.0 ⁇ 3.0 g,
  • the unit dose comprises about 25 ⁇ 7,500 mg of active ingredients. In some embodiments, the unit dose comprises about 25 ⁇ 50 mg, 50 ⁇ 100 mg, 100 ⁇ 600 mg, 200 ⁇ 700 mg, 300 ⁇ 800 mg, 400 ⁇ 900 mg, 500 ⁇ 1000 mg, 1.0 ⁇ 2.0 g, 2.0 ⁇ 3.0 g, 3.0 ⁇ 4.0 g, 4.0 ⁇ 5.0 g, 5.0 ⁇ 6.0 g, 6.0 ⁇ 7.0 g, 7.0 ⁇ 8.0 g, 8.0 ⁇ 9.0 g, 9.0 ⁇ 10 g, 10 ⁇ 11 g, 11 ⁇ 12 g, 12 ⁇ 12.5, or > 12.5 of active ingredients.
  • a second aspect provides a method of making a composition of the present invention, said method comprising the steps of:
  • the mixture is an isotropic or homogeneous mixture.
  • At least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, at least one active ingredient is a cannabinoid or cannabinoid extract.
  • the invention provides a method of making a composition of the present invention, said method comprising the steps of:
  • At least one active ingredient at least one surfactant; and, optionally, one or more fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof;
  • the mixture is an isotropic or homogeneous mixture.
  • At least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, at least one active ingredient is a cannabinoid or cannabinoid extract.
  • the mixture is an isotropic or homogeneous mixture.
  • the triglyceride is an MCT or LCT, as provided herein.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, the active ingredient is a cannabinoid or cannabinoid extract.
  • said at least one active ingredient is one or more cannabinoids, and/or ethyl pyruvate, and/or one or more terpenes.
  • the method of making the composition of the first aspect comprises the steps of:
  • At least one active ingredient at least one surfactant; and at least one triglyceride
  • said at least one surfactant comprises one or more selected from polysorbate 80, polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40), D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS), lauroyl macrogol 32 glycerides (e.g., GELUCIRE® 44/14), or a combination thereof; and, wherein said triglyceride is a medium ⁇ chain triglyceride and/or long ⁇ chain triglyceride; and
  • the mixture is an isotropic or
  • the triglyceride is an MCT or LCT, as provided herein.
  • At least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, at least one active ingredient is a cannabinoid or cannabinoid extract.
  • the invention further provides for a method for increasing at least one parameter selected from the group consisting of solubility, dissolution, oral bioavailability, Cmax, absorption, onset of action, for decreasing time to Tmax, or for decreasing intra ⁇ patient variability comprising the steps of:
  • At least one active ingredient at least one surfactant; and, optionally, one or more fatty acid, monoglyceride, diglyceride, triglyceride, or a combination thereof;
  • the triglyceride is an MCT or LCT, as provided herein.
  • At least one active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, at least one active ingredient is a cannabinoid or cannabinoid extract. In one embodiment, said at least one active ingredient is one or more cannabinoids, and/or ethyl pyruvate, and/or one or more terpenes.
  • compositions of the present invention can significantly decrease the amount of time for the onset of action of the active ingredient.
  • the composition, e.g., cannabinoid composition, of the present invention has an onset of action within 15
  • the formulations of the present invention can further significantly decrease the peak time (the time it takes for an active ingredient to reach maximum effect) of the active ingredient.
  • the composition e.g., cannabinoid composition
  • the composition has a peak time within 90 minutes, within 80 minutes, within 70 minutes, within 60 ⁇ 70 minutes, within 60 minutes, within 50 minutes, within 45 ⁇ 60 minutes, within 45 minutes, within 40 minutes, or within 30 minutes post administration.
  • the formulations of the present invention can further significantly increase the peak effect, i.e., the maximum effect of the active ingredient, e.g., the psychotropic effect of THC.
  • the method for enhancing at least one parameter selected from the group consisting of solubility, dissolution, oral bioavailability and absorption comprises the steps of:
  • the mixture is an isotropic or homogeneous mixture.
  • the triglyceride is an MCT or LCT, as provided herein.
  • the active ingredient is selected from a cannabinoid, cannabinoid extract, terpene, or terpene extract. In a further embodiment, the active
  • ingredient is a cannabinoid or cannabinoid extract.
  • said at least one triglyceride comprises a medium ⁇ chain triglyceride and/or long ⁇ chain triglyceride
  • said at least one surfactant comprises one or more selected from polysorbate 80, polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40), or D ⁇ Tocopherol polyethylene glycol 1000 succinate (TPGS) and/or
  • the mixture is an isotropic or homogeneous mixture.
  • a third aspect of the present invention provides for a method of treating a disease or disorder in a subject (e.g., human) who would benefit from at least one active ingredient of the present invention, the method comprising the step of administering an effective amount of a composition of the present invention to said subject.
  • a subject e.g., human
  • the subject is a human.
  • said composition comprises at least one cannabinoid, cannabinoid extract, terpene, terpene extract, or a combination thereof.
  • the disease or disorder is selected from: Alzheimer Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), spasticity, pain, anxiety, and
  • the disease, condition, or pathology is inflammation or an inflammatory condition.
  • the method includes reducing the level of a cytokine in a mammal, wherein said cytokine is selected from the group consisting of: tumor necrosis factor (TNF), interferon ⁇ gamma (IFN ⁇ gamma), interleukin ⁇ 1 ⁇ beta (IL ⁇ 1 ⁇ beta), and high mobility group B ⁇ 1 (HMGB ⁇ 1).
  • TNF tumor necrosis factor
  • IFN ⁇ gamma interferon ⁇ gamma
  • IL ⁇ 1 ⁇ beta interleukin ⁇ 1 ⁇ beta
  • HMGB ⁇ 1 high mobility group B ⁇ 1
  • the method includes inhibiting IL ⁇ 1 ⁇ induced inflammatory and catabolic pathways, preferably, NF ⁇ B and JNK activation, and the expression of inflammatory (iNOS) and catabolic (MMP ⁇ 1 and ⁇ 13) genes.
  • the method includes reducing MCP ⁇ 1 production via NF ⁇ kB activation.
  • the method includes reducing NO production, reducing IFN ⁇ gamma, reducing IL ⁇ 4, IL ⁇ 6, or for increasing IL ⁇ 10.
  • the inflammation or an inflammatory condition is selected from the group consisting of: asthma, cachexia secondary to acquired immune deficiency
  • AIDS cachexia secondary to infection or malignancy
  • chronic obstructive pulmonary disease (COPD) Crohn's disease
  • endotoxic shock fever and myalgia due to infection
  • gouty arthritis and other arthritic conditions graft v. host rejection
  • gram negative sepsis keloid formation
  • multiple sclerosis osteoarthritis
  • psoriasis and eczema pulmonary fibrosis
  • pulmonary sarcoidosis reperfusion injury
  • rheumatoid arthritis rheumatoid
  • the disease, condition or pathology in a mammal is a central nervous system (CNS) disorder.
  • CNS central nervous system
  • the CNS disorder is selected from any one of: Alzheimer's disease, amyotrophic lateral sclerosis,
  • adrenoleukodystrophy brain injury, cerebral infarction, corticobasal degeneration (CBD), Creutzfeldt ⁇ Jakob Disease, epilepsy, Friedrich's ataxia, frontal lobe degeneration
  • frontotemporal dementia frontotemporal dementia
  • geriatric dementia Huntington's disease
  • ischemic stroke Lewy body dementia
  • multi ⁇ infarct dementia multiple sclerosis
  • multiple system atrophy MSA
  • olivopontocerebe/laratrophy OPCA
  • Parkinsonian disorders Parkinson's disease
  • Pick's Disease progressive supranuclear palsy
  • Shy ⁇ Drager syndrome spinal cord injury, spasticity, spinal ischemia, striatonigral degeneration (SND), stroke, vascular dementia.
  • SND striatonigral degeneration
  • the CNS disorder is hyperreflexia.
  • the CNS disorder is a demyelinating condition.
  • the demyelinating condition is selected from any one of the following: acute disseminated encephalomyelitis, acute transverse myelitis, acute viral encephalitis,
  • adrenoleukodystrophy ALD
  • APN adrenomyeloneuropathy
  • AIDS ⁇ vacuolar myelopathy Binswanger's disease (subcortical leukoencephalopathy ), central pontine myelinolysis (CPM), disseminated necrotizing leukoencephalopathy (DNL), HTLV ⁇ associated myelopathy, Leber's hereditary optic atrophy, leukodystrophy, multiple sclerosis (MS), multiple sclerosis variants such as Neuromyelitis Optica (Decic's Disease), Diffuse Sclerosis, Transitional Sclerosis, Acute Disseminated Encephalomyelitis, and Optic Neuritis, progressive multifocal leukoencephalopathy (PML), radiation necrosis, Schilder’s disease, subacute sclerosing panencephalitis, or tropical spastic paraparesis.
  • the ALD adrenoleukodystrophy
  • APN ad
  • demyelinating condition is multiple sclerosis.
  • the method is for slowing the progression of MS.
  • a human with MS is treated over at least about a time selected from the group consisting of: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 ⁇ 25 weeks, 25 ⁇ 35 weeks, 35 ⁇ 45 weeks, 45 ⁇ 52 weeks, and more than 52 weeks.
  • the human with MS (MS patient) that is treated with the active ingredients or composition of the invention displays an improvement in an outcome measure selected from the group consisting of: Ashworth score, Rivermead Mobility Index, 6 ⁇ minute walk test, timed 25 feet walk test, timed 10 ⁇ meter walk test, Dynamic Gait Index, Timed Up and Go test, EDSS (extended disability status scale), and appearance of exacerbations or MRI (magnetic resonance imaging); wherein said MS patient treated with the active ingredients or composition of the present invention is compared to a MS patient administered placebo over the same time. The comparison is preferably between a treated cohort and placebo cohort wherein a measure of therapeutic effectiveness in this regard is a statistically significant difference.
  • an outcome measure selected from the group consisting of: Ashworth score, Rivermead Mobility Index, 6 ⁇ minute walk test, timed 25 feet walk test, timed 10 ⁇ meter walk test, Dynamic Gait Index, Timed Up and Go test, EDSS (extended disability status scale), and appearance of exacerbations or MRI (magnetic
  • the patient or cohorts may be treated with using the best standard of care which may include treatment with one or more MS drugs.
  • the slowing of progression of MS is due to the composition of the invention, and not the results of natural periods of remission between attacks.
  • the MS is relapsing remitting MS.
  • the MS is primary progressive MS.
  • the EDSS is a means to grade clinical impairment due to MS (Kurtzke, Neurology. 1983 Nov; 33(11):1444 ⁇ 52).
  • the scale ranges from 0 (normal) to 10 (death due to MS).
  • a decrease of one full step defines an effective treatment in the context of the present invention (Kurtzke, Ann Neurol. 1994;36 Suppl:S73 ⁇ 9).
  • the invention provides for a method of reducing an MS patient’s EDSS scale by at least one full step comprising the step of treating said MS patient with a therapeutically effective amount of the active ingredients or composition of the present invention over at least about a time selected from the group consisting of: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 ⁇ 25 weeks, 25 ⁇ 35 weeks, 35 ⁇ 45 weeks, 45 ⁇ 52 weeks, and more than 52 weeks.
  • Exacerbations are defined as the appearance of a new symptom that is attributable to MS and accompanied by an appropriate new neurologic abnormality. The exacerbation must last at least 24 hours and be preceded by stability or improvement for at least 30 days. Exacerbations are mild, moderate, or severe according to changes in a Neurological Rating Scale (Sipe et al., Neurology. 1984 Oct;34(10):1368 ⁇ 72.). An annual exacerbation rate and proportion of exacerbation ⁇ free patients are determined. In one embodiment, therapy is deemed to be effective if there is a statistically significant difference in the rate or proportion of exacerbation ⁇ free patients between the treated group and the placebo group for either of these measurements. A measure of effectiveness as therapy in this regard is a statistically significant difference in the time to first exacerbation or duration and severity in the treated group compared to control group.
  • MRI can be used to measure active lesions.
  • the presence, location, and extent of MS lesions are determined by radiologists. Three analyses may be done: evidence of new lesions, rate of appearance of active lesions, percentage change in lesion area (Paty et al., Neurology 43:665, 1993).
  • improvement due to therapy is established when there is a statistically significant improvement in an individual patient compared to baseline or in a treated group versus a placebo group.
  • therapy is effective when there is an improvement in one or more disabling neurological impairments such as blindness, paralysis, incoordination, and bowel or bladder dysfunction, as well as a less apparent symptom such as fatigue.
  • neurological impairments such as blindness, paralysis, incoordination, and bowel or bladder dysfunction
  • a less apparent symptom such as fatigue.
  • fatigue includes loss of power, capacity to respond to stimulation, or the tiredness, or sleepiness associated with multiple sclerosis.
  • therapy is effective where there is a lessoning of a disorder caused by an impairment in the function of one or more of the following systems: pyramidal, cerebella, brainstem, sensory, bowel and bladder, visual, cerebral or other neurologic abnormality.
  • the pyramidal function is selected from the development of: paraparesis, hemiparesis, monoparesis, quadriparesis, monoplegia, paraplegia, quadriplegia, or hemiplegia.
  • the system is cerebella and the disorder is selected from the development of ataxia, including truncal or limb ataxia.
  • the system is brainstem and the disorder is selected from the development of nystagmus, extraocular weakness, or
  • treatment is effective when there is a reduction in: the inflammatory response in the brain and other regions of the nervous system, breakdown or disruption of the blood ⁇ brain barrier, appearance of lesions in the brain, tissue destruction,
  • demyelination demyelination, autoimmune inflammatory response, acute or chronic inflammatory response, neuronal death, and/or neuroglia death.
  • the pain is chronic pain. In another embodiment, the pain is acute pain. In a further embodiment, the acute pain is a migraine. In a further embodiment, the pain is selected from any one or more of the following: post ⁇ herpetic neuralgia,
  • the pain is cancer pain.
  • the nausea and/or vomiting results from a chemotherapy, e.g., cancer chemotherapy. In another embodiment, the nausea and/or vomiting results from opioid use.
  • a chemotherapy e.g., cancer chemotherapy.
  • the nausea and/or vomiting results from opioid use.
  • the method is for increasing socialization, increasing relaxation, inducing sleep, reducing the time needed to fall asleep, or for inducing a psychotropic effect (commonly known as a “high”).
  • the method is for reducing the amount of opioid(s) used by a subject suffering from pain or used by a subject addicted to an opioid.
  • composition may be administered once, twice, three, or four times a day, or as needed.
  • the invention provides a method of reducing the intensity or duration of pain in a subject (i.e., a subject, e.g., human), in need thereof, comprising the step of administering to the subject an effective amount of a cannabinoid containing composition of the present invention.
  • the method decreases pain intensity in the subject.
  • the method decreases pain duration in the subject.
  • the pain is acute pain.
  • the pain is chronic pain.
  • the subject has reduced pain intensity for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, at least 18 hours, or at least 24 hours post administration.
  • the cannabinoid composition of the present invention has a maximum pain relieving effect between 1 ⁇ 4 hours or between 1.5 ⁇ 2.5 hours post administration. In another embodiment, the cannabinoid composition of the present invention has an onset of pain relieving effect within 15 minutes, 20 minutes, 25 minutes, 30 minutes, or within 45 minutes post administration.
  • the invention provides a method of reducing or preventing nausea or vomiting in a subject in need thereof, comprising administering to the subject an effective amount of a cannabinoid containing composition of the present invention.
  • the nausea or vomiting is opioid induced nausea or vomiting.
  • the opioid inducing the nausea or vomiting may be an opioid analgesic such as hydrocodone,
  • the cannabinoid containing composition is administered 0 ⁇ 30 minutes, 30 ⁇ 60 minutes prior to administration of the opioid. In another embodiment, the cannabinoid containing composition is administered 60 minutes prior to administration of the opioid. In another embodiment, the cannabinoid containing composition is administered concurrently with the administration of the opioid. In one embodiment, the nausea or vomiting occurs after surgery and results from anesthesia.
  • the subject has reduced intensity of nausea in the 2, hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 18 hours, or 24 hours following initial administration of the cannabinoid containing composition. In one embodiment, the subject has reduced vomiting in the 4 hours, 6 hours, 8 hours, 12 hours, 18 hours, or 24 hours following initial administration of the cannabinoid containing composition. In one
  • the cannabinoid composition of the present invention has a maximum nausea or vomiting reducing effect between 1 ⁇ 4 hours, 1 ⁇ 3 hours, 2 ⁇ 4 hours, or between 1.5 ⁇ 2.5 hours post administration. In another embodiment, the cannabinoid composition of the present invention has an onset of nausea or vomiting reducing effect within 15 minutes, 20 minutes, 25 minutes, 30 minutes, or within 45 minutes post administration.
  • the method of reducing nausea or vomiting in a subject includes reducing the occurrence of nausea or vomiting.
  • the composition of the present invention has a Tmax that is about 1 ⁇ 6 hours. In a further embodiment, the Tmax is about 1 ⁇ 3 hours in a fasted subject. In a further embodiment, the Tmax is about 2 ⁇ 4 hours in a fasted subject.
  • composition of the present invention has an about 20 ⁇ 400% greater absorption in the 90 minutes following administration than MARINOL®. In another embodiment, the composition of the present invention has an about 20 ⁇ 400% greater absorption, 100 ⁇ 200%, 200 ⁇ 300%, or 300 ⁇ 400% in the 60 minutes following administration than MARINOL®.
  • composition of the present invention has an about 20 ⁇ 400%, 100 ⁇ 200%, 200 ⁇ 300%, or 300 ⁇ 400% less first ⁇ pass metabolism than MARINOL®.
  • Cannabidiol was procured from CBD internationals and marijuana THC extract was procured from New England Treatment Access (NETA). GELUCIRE® 44/14, Peceol,
  • Poloxamer 124, PEG 25, PEG 400 and polyoxyethylene 10 oleyl ether (Oleth ⁇ 10 or BRIJ 97) were procured from VWR.
  • Vitamin E TPGS d ⁇ alpha tocopheryl polyethylene glycol 1000 succinate
  • Polysorbate 80 was procured from Modernist Pantry and Solutol® HS 15 (Kolliphor® HS 15) was procured from BASF.
  • Solutol® HS 15 is a tradename for macrogol 15 hydroxystearate (also called polyoxyl 15 hydroxystearate) and contains soluble non ⁇ ionic surfactants (70%) and PEG (3) formed by the reaction of 12 ⁇ hydroxystearic acid with ethylene oxide at alkaline pH (12).
  • GELUCIRE® 44/14 (Gattefossé) is a tradename for lauroyl macrogol 32 glycerides (synonyms: lauroyl polyoxyl ⁇ 32 glycerides, PEG ⁇ 32 lauroyl polyoxylglycerides or PEG ⁇ 32 lauric glycerides) that is obtained by polyglycolysis of hydrogenated coconut oil (medium and long chain triacylglycerols) and PEG ⁇ 32. It is composed of a defined admixture of C8 ⁇ C18 mono ⁇ , di ⁇ and triacylglycerols (20% w/w), PEG ⁇ 32 mono ⁇ and diesters and free PEG ⁇ 32 (80% w/w). The main fatty acid present is lauric acid which accounts for 45% on average of the total fatty acids. See Jannin, V. OCL 16(4):267 ⁇ 272 (2009).
  • compositions comprising of long chain triglycerides or medium chain triglycerides with a variety of surfactants were prepared and tested to determine whether they produce micro ⁇ and nano ⁇ emulsions via self ⁇ emulsifying mechanisms. Formation of self ⁇
  • CBD Cannabidiol
  • THC extract 1 g
  • 10 mL of excipient (9 g) surfactant or triglyceride
  • the resulting solution was stirred for 30 minutes at 25 °C in case of liquid excipients.
  • Semisolid and solid excipients were heated to 80 °C (to convert them into a liquid state) and stirred for 30 minutes. Stirring was continued until CBD or THC was completely soluble in the excipient forming a clear solution.
  • This clear solution was used for dissolution studies in water by adding 45 microliter in 12 mL water (0.375%)with continuous stirring at 25 °C.
  • the resulting emulsion was stirred for 2 hours before particle size measurement.
  • the particle size was measured using Dynamic Light Scattering instrument (Malvern Zetasizer Nano).
  • the single excipient data was used as an initial screen for candidate surfactants.
  • the candidate surfactants were then used in compositions (both binary and ternary) that were screened to determine whether they were self ⁇ emulsifying.
  • THC extract, TPGS, GELUCIRE® 44/14, Polysorbate 80 (PS 80), LCT oil and MCT oil were mixed in a ratio as shown in Table 4 in a 20 mL scintillation vials.
  • Polysorbates 20, 40, 60 and 80 (or polyoxyethylene (20) sorbitan monoesters, where the lipid group is laurate, palmitate, stearate and oleate for polysorbates 20, 40, 60 and 80, respectively) and sorbitan monooleate (Span 80) were obtained from Croda Health Care or food ⁇ grade manufacturers (Modernist Pantry).
  • HLB Hydrophile to Lipophile Balance
  • surfactant blends with varying HLB numbers between 6 and 14 were prepared by mixing Polysorbate 80 and Span 80 at different mass ratios. For higher HLB numbers from 14.9 to 16.7, pure polysorbate surfactants were used.
  • Cannabis extract distillate, or distillate was obtained from New England Treatment Access (NETA, Franklin, MA). In ⁇ house cannabinoid potency analysis by RP ⁇ HPLC showed that the distillate was rich in ⁇ 9 ⁇ THC content ( ⁇ 75%). Three other cannabinoids, cannabidiol ( ⁇ 3.6%), cannabichromene ( ⁇ 1.4%), tetrahydrocannabivarin ( ⁇ 1.3%) and cannabinol ( ⁇ 0.4%) accounted for another 6.7% of the distillate mass.
  • NETA New England Treatment Access
  • cannabidivarin cannabidivarin
  • cannabigerolic acid ⁇ 8 ⁇ tetrahydrocannabinol
  • tetrahydrocannabinolic acid quantitation limit ( ⁇ 0.1%)
  • the distillate rich in ⁇ 9 ⁇ THC content was homogenized for at least 1 hour at 75°C.
  • Distillate ⁇ surfactant formulations with varying surfactant content of 50%, 75% and 90% (where the remainder of the formulation was the distillate) were prepared by adding the required quantity of surfactant to the distillate, followed by thorough homogenization for at least 1 hour at 75°C in glass vials.
  • the volume accuracy of viscous liquids was ensured by using a calibrated positive displacement pipette.
  • the homogeneity of the formulations was assessed by visual inspection on an illuminator.
  • Aqueous emulsions were prepared at 1.0 or 0.1 % by adding the required volume of formulation to deionized water in clean, glass vials. using a positive displacement pipette in clean, glass vials. The volume accuracy of viscous liquids was ensured by using a calibrated positive displacement pipette. After each dilution, the aqueous emulsion was vortexed for 10 seconds. Vials were visually inspected for clarity and turbidity on an illuminator and assigned a “turbidity rank” from 0 to 5 based on their apparent turbidity. Turbidity rank values of 0 ⁇ 5 corresponded to transparent, transparent to translucent, translucent,
  • the lipid tail was a saturated lipid of increasing chain length, while that of polysorbate 80 was an unsaturated oleate group.
  • Span 80 had the same lipid functionality as that of polysorbate 80, its HLB number was considerably lower than those of polysorbates since it is not ethoxylated. Therefore, HLB numbers between 6 and 14 were obtained by blending polysorbate 80 and Span 80 at different mass ratios, while HLB numbers 14.9, 15, 15.6, 16.7 corresponded to those of pure polysorbates 60, 80, 40 and 20, respectively.
  • Emulsion particle size vs. surfactant HLB number at fixed formulation composition and dilution Emulsion particle size vs. surfactant HLB number at fixed formulation composition and dilution:
  • Figure 1 shows the dependence of D, the Z ⁇ average particle diameter, on surfactant HLB number for 1.0 vol.% aqueous emulsions of formulations containing 50 vol.% surfactant.
  • the D value showed a non ⁇ linear, parabolic dependence on the apparent HLB number of the surfactant.
  • D values decreased gradually
  • FIG. 2 shows the dependence of D value on HLB number at different surfactant content. Surprisingly, with increasing surfactant content the dependence of particle size on HLB number was reversed and D gradually decreased with increasing HLB number for formulations containing ⁇ 75 vol.% surfactant. The results show an overall decrease in particle size with increasing HLB number at high surfactant concentrations.
  • 1.0 % aqueous emulsions also changed with varying surfactant content.
  • Formulations containing 75 % surfactant formed 1.0% emulsions with a turbidity rank of 4 ⁇ 5, while those containing 90% surfactant formed 1.0% emulsions with a turbidity rank of 0 ⁇ 4.
  • apparent turbidity decreased with increasing HLB number.
  • compositions containing stearate fatty acids generally appeared more turbid.
  • Figure 4 shows the dependence of D on HLB number at an aqueous emulsion concentration of 0.1 %. The most pronounced change in emulsion particle size upon further dilution in water was observed for formulations with the lowest surfactant content. At 50% surfactant, D>1 ⁇ m for all 0.1 % emulsions. With increasing surfactant content, the apparent change (increase) in particle size upon dilution decreased.
  • Figure 5 shows the direct relationship of apparent turbidity and Z ⁇ average particle size measured by DLS for 0.1% emulsions.
  • a “solvent capacity” or “dilutability” parameter as the ratio of D value measured for 1.0 % to D measured for 0.1 % aqueous emulsions.
  • a dilutability parameter of 1.0 and 0.1 would correspond to a 0% and 900% increase in particle size upon dilution from 1.0 % to 0.1 %, respectively.
  • Figure 6 shows a comparison of dilutability curves as a function of surfactant HLB number at different surfactant content. These data suggest that regardless of the HLB number, the dilutability was low at 50% surfactant content. Increasing surfactant content to 75 % significantly improved dilutability, while dilutability values were high and generally ⁇ 0.9 for 90% surfactant content.
  • the formulations of the present invention can be tested in vivo using methods well known in the art.
  • animals e.g., beagle dogs
  • Blood is then collected at various time points, e.g., 0.5, 1, 2, 4, 6, 8, 24, 30, 48 hours post ⁇ dose and stored (e.g., ⁇ 80 ⁇ 10°C) for subsequent analysis.
  • Plasma/serum samples are then analyzed using validated methods for THC, CBD,11 ⁇ Hydroxy
  • THC THC ⁇ COOH.
  • PK analysis of the concentrations of test article are determined, for example, using a non ⁇ compartmental module of WinNonlin. Individual parameters, such as, Cmax, Tmax, AUC, t1/2, Vd, and Clearance are tabulated as appropriate.
  • Flavoring selection for use as beverage additive is
  • Flavoring oils and sweetener were added to formulations A30 and A31 to determine their effect on particle size (Table 8) and their suitability as beverage additives.
  • the artificial orange flavoring contained 80% medium ⁇ chain triglycerides, 10 ⁇ 15% limonene, 0.5 ⁇ 1% acetaldehyde, 0.5 ⁇ 1 % linalool, 0.1 ⁇ 0.5% citral and vitamin E.
  • Formulations BA16, BA18, and BA19 had superior taste ⁇ masking, however, the addition of the flavoring significantly increased the dissolution time (the time to form a transparent micellar dispersion after being added to an aqueous medium).
  • a series of formulations (Table 10) comprising a co ⁇ solvent were made and tested. Dissolution rate was assessed visually, by adding formulations (corresponding to 10 mg cannabinoid dose) to 237 ml water at room temperature followed by brief mixing (approx. 10 sec.) using a stir bar. After mixing, samples were observed for dissolution as determined by formation of a clear, single ⁇ phase emulsion.
  • propylene glycol formulation (BA24) took up to 5 minutes.
  • Viscosity measurements were conducted using a microchannel viscometer
  • Dissolution rate was measured by adding each formulation to deionized water to obtain a 0.1 wt% formulation, while stirring the deionized water at 100 rpm. Dissolution time and emulsion appearance were assessed visually.
  • Polysorbate 80 Ethanol System:
  • Figure 7 shows the dependence of dissolution time and viscosity on polysorbate 80 concentration in binary ethanol: polysorbate 80 systems (0 wt.% and 100 wt.% polysorbate 80 correspond to 100 wt.% and 0 wt.% ethanol, respectively).
  • compositions enabling dissolution of the formulation within 2 ⁇ 3 minutes contained ⁇ 25 wt.% ethanol and have a viscosity value ⁇ 45 cP.
  • Polyethylene glycol (PEG) 40 hydrogenated castor oil Ethanol System:
  • Figure 8 shows the dependence of dissolution time and viscosity on polyethylene glycol (PEG) 40 hydrogenated castor oil concentration in binary ethanol: polyethylene glycol (PEG) 40 hydrogenated castor oil systems (0 wt.% and 100 wt.% polyethylene glycol (PEG) 40 hydrogenated castor oil correspond to 100 wt.% and 0 wt.% ethanol, respectively).
  • Both viscosity and dissolution time increased with increasing polyethylene glycol (PEG) 40 hydrogenated castor oil content. Therefore, increasing ethanol content led to faster dissolution in a manner that correlated well with a corresponding decrease in formulation viscosity.
  • Preferred compositions enabling dissolution of the formulation within 2 ⁇ 3 minutes contained ⁇ 25 wt.% ethanol. More preferred formulations enabling dissolution within 2 minutes contained ⁇ 37.5 wt.% ethanol and had a viscosity value ⁇ 80 cP.
  • Aqueous emulsions were prepared by diluting BA22 and BA25 formulations to different final THC ⁇ distillate concentrations (2, 1, 0.5, 0.25, 0.1 and 0.05 wt.% THC distillate). Dilutions were prepared using DI water at 3 different temperatures (4°C, 21°C and 60°C). After dilution, each vial was visually inspected. The transparency was recorded as either opaque, translucent or transparent. The formation of a transparent emulsion was attributed to a predominantly nanoparticulate size distribution.
  • emulsions transitioned from an opaque emulsion (at 2wt%) to a translucent emulsion (at 0.25wt.%) and from a translucent emulsion to a transparent emulsion (at 0.1wt.%) with increasing dilution.
  • the transition from an opaque to a translucent emulsion (at 0.1wt.%) and from a translucent to a transparent emulsion (at 0.05wt.%) occurred at lower THC ⁇ distillate concentration
  • THC ⁇ distillate concentration values at which the emulsions were transparent were attributed to a majority nanoparticulate size distribution.
  • the maximum THC ⁇ distillate concentration with majority nanoparticulate size distribution ([CN] max ) values for 2 tested formulations were determined as (see Table 12):
  • Table 12 [CN] max values for BA22 and BA25 formulations at different dilution temperatures.
  • polysorbate 80 formulation (BA22). Based on [CN] max values, BA25 was the preferred formulation.
  • the maximum preferred THC ⁇ distillate concentration in a rapid dispersion THC ⁇ distillate: polyethylene glycol (PEG) 40 hydrogenated castor oil: ethanol system was estimated using the following method. First, formulations at two extreme THC ⁇ distillate concentrations were prepared. A stock placebo polyethylene glycol (PEG) 40 hydrogenated castor oil: ethanol formulation (6 ⁇ 32 ⁇ 1) with minimum preferred ethanol content (25 wt.%) was used as lower (0 wt.%) extreme. A second stock formulation (6 ⁇ 32 ⁇ 2) containing THC ⁇ distillate: polyethylene glycol (PEG) 40 hydrogenated castor oil: ethanol in 1:1:1 mass ratio was used as the upper extreme. After assessing the dissolution of these 2 stock solutions, formulation iterations were prepared using these 2 stock solutions to determine the maximum THC ⁇ distillate concentration at which a transparent (nanoparticulate ⁇ rich)
  • THC ⁇ distillate polyethylene glycol (PEG) 40 hydrogenated castor oil: ethanol rapid dispersion compositions comprised approximately ⁇ 25 wt.% ethanol and ⁇ 25 wt.% THC ⁇ distillate.
  • PEG polyethylene glycol
  • the artificial orange flavoring contained 80% medium ⁇ chain triglycerides, 10 ⁇ 15% limonene, 0.5 ⁇ 1% acetaldehyde, 0.5 ⁇ 1 % linalool, 0.1 ⁇ 0.5% citral and vitamin E. **For emulsion appearance, PS: Phase separation; O: Opaque, TL: Translucent, TP: Transparent.
  • Some beverage additive compositions listed in Tables 14 and 15 rapidly self ⁇ emulsified into micellar dispersions with a particle size of less than 50 nm when added to water or another beverage of choice.
  • Some compositions contained ⁇ 25 wt.% THC ⁇ distillate, ⁇ 25 wt.% ethanol, ⁇ 25 wt.% artificial orange flavor and ⁇ 10 wt.% sucralose.
  • Figure 9 shows the minimum amount of PEG ⁇ 40 hydrogenated castor oil in some compositions plotted as the minimum mass ratio of PEG ⁇ 40 hydrogenated castor oil to THC ⁇ distillate versus the concentration of artificial orange flavor (artificial orange flavoring contained 80% medium ⁇ chain triglycerides, 10 ⁇ 15% limonene, 0.5 ⁇ 1% acetaldehyde, 0.5 ⁇ 1 % linalool, 0.1 ⁇ 0.5% citral and vitamin E).
  • artificial orange flavoring contained 80% medium ⁇ chain triglycerides, 10 ⁇ 15% limonene, 0.5 ⁇ 1% acetaldehyde, 0.5 ⁇ 1 % linalool, 0.1 ⁇ 0.5% citral and vitamin E).
  • Equation [1] describes the minimum PEG ⁇ 40 hydrogenated castor oil (PEG ⁇ 40 HCO) to THC ⁇ distillate mass ratio in some compositions as a function of the concentration of the artificial orange flavor (artificial orange flavoring contained 80% medium ⁇ chain triglycerides, 10 ⁇ 15% limonene, 0.5 ⁇ 1% acetaldehyde, 0.5 ⁇ 1 % linalool, 0.1 ⁇ 0.5% citral and vitamin E):
  • compositions comprising a cannabinoid and ethyl pyruvate:
  • CBD extract, Ethyl Pyruvate (EP), and Polysorbate 80 (PS 80) were mixed in a ratio as shown in Table 16 in 20 mL scintillation vials.
  • formulations containing greater than 65% PS 80 produced emulsions with average particles sizes below 500 nm and formulations containing less than 65% PS 80 produced emulsions with average particle sizes above 500 nm.
  • THC extract, CBD, EP, terpenes, and PS 80 were mixed in a ratio as shown in Table 17.
  • Table 18 lists the amounts of ingredients for different gummy batch sizes. Additional batch sizes can be scaled accordingly.
  • Flavors used were as follows: coconut (white), blueberry (blue), strawberry ⁇ melon (green; flavor 1 ⁇ 2 and 1 ⁇ 2), watermelon (pink: use 1 ⁇ 2 number of drops of red), blood orange (red and orange equal parts), mango (light orange: use 1 ⁇ 2 number of drops of orange).
  • Bloomed gelatin is added to the sugar mixture in semi ⁇ small chunks and mix well with a spatula until all gelatin melts. Gelatin mixture is weighed and amount of cannabinoid formulation required for desired dose is calculated.
  • the cannabinoid formulation is a cannabinoid composition of the present invention.
  • the cannabinoid formulation may consist of cannabinoid extract dissolved in MCT (total percent between 10 ⁇ 80 w/v) and polysorbate 80 (total percent between 10 ⁇ 90 w/v). The ingredients are mixed well with a mixer and poured into a funnel. Foam is allowed to come to the top (5 minutes) before pouring.
  • the mixture is poured into square pans sprayed with a non ⁇ stick spray. Foam is not allowed to pour into pans.
  • the funnel is topped off as needed with the remaining gummy mixture.
  • Trays are transferred to a rolling rack and allowed to set up slightly before moving to refrigerator.
  • Gummies are cut into cubes. Each gummy cube typically contains a cannabinoid dose ranging from 1 – 10 mg.
  • A34 and A30 provided a more intense effect than A32. Specifically, subjects experienced a 124% greater peak effect for A34 versus A32 and 60% greater peak effect for A30 versus A32. The effect of A30 was also less variable than that of A32, with 83% lower interquartile range with A30.
  • Peak time Similar to onset time, peak times of the effects of A34 and A30 were also shorter than that of A32. On average, peak effects were observed within 80 ⁇ 90 for A32, within 60 minutes for A30, and within 45 minutes for A34.
  • Duration The duration of effect that subjects experienced for A30 and A34 was similar to that of A32 but less variable, with 60% lower standard deviation.

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Abstract

L'invention concerne des compositions comprenant un ou plusieurs ou au moins deux principes actifs, par exemple un cannabinoïde, un extrait de cannabinoïde, un terpène ou un extrait de terpène. L'invention comprend des formulations de cannabinoïdes qui comprennent des formulations auto-émulsifiantes et des dispersions micellaires, ainsi que des procédés de fabrication et des méthodes d'utilisation de celles-ci. Certaines formulations comprennent un cannabinoïde et un tensioactif. Les formulations présentent une dissolution, une stabilité, une absorption et/ou une biodisponibilité par voie orale améliorées. Certaines des formulations sont des formulations à dispersion rapide.
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