Therapeutic compositions, components and methods of preparation and use thereof
View Patent ↗Disclosed are compositions, components and dosage forms containing at least one cannabinoid as well as methods of preparation and use thereof. Compositions, components and/or dosage forms may include, based on the total weight of the composition, component or dosage form, about 10 wt % to about 25 wt % tetrahydrocannabinol (THC), about 0.001 wt % to about 1.0 wt % cannabidiol (CBD), about 0.01 wt % to about 5 wt % β-Myrcene, and about 0.01 wt % to about 5 wt % Ocimene 2.
1 . A dosage form comprising:
a cannabis component, comprising based on the total weight of the cannabis component:
about 10 wt % to about 25 wt % of tetrahydrocannabinol (THC);
about 0.001 wt % to about 1.0 wt % of cannabidiol (CBD); and
at least one of about 0.01 wt % to about 5 wt % β-Myrcene or about 0.01 wt % to about 5 wt % of Ocimene 2;
a plasticizer;
a bulking agent;
a diluent; and
a synthetic excipient.
2 . The dosage form of claim 1 , wherein the dosage form is a solid oral dosage form.
3 . The dosage form of claim 1 , wherein the dosage form is at least one of a tablet, a hard-shell capsule, a soft-shell capsule, a caplet, a sublingual tablet, a sublingual film, a buccal tablet, a buccal film, a gummy, a matrix, particles, a spray, or combinations thereof.
4 . The dosage form of claim 1 , wherein the dosage form is formulated for at least one of oral administration, parenteral administration, inhalation, rectal administration, intravaginal administration, sublingual administration, intramuscular injection, transdermal administration, nasal administration, buccal administration, insufflation, or spinal anesthesia.
5 . The dosage form of claim 1 , wherein the synthetic excipient comprises at least one of a colorant, boric acid, antioxidant, buffering agent, alginates, granulating agent, stearic acid, silicon dioxide, sodium lauryl sulfate, aspartame, chelating agent, granulating agent, flavorant, surfactant, solubilizer, stabilizer, hydrophilic polymer, hydrophobic polymer, castor wax, lipophilic material, absorption enhancer, preservative, absorbent, cross-linking agent, bioadhesive polymer, pore former, osmotic agent, polycarboxylic acid or combinations thereof.
6 . The dosage form of claim 1 , wherein the THC comprises A9-tetrahydrocannabinol (Δ 9 -THC).
7 . The dosage form of claim 1 , comprising at least about 1 mg/g to about 15 mg/g β-Myrcene, about 2 mg/g to about 14 mg/g β-Myrcene, about 5 mg/g to about 10 mg/g β-Myrcene or about 6 mg/g to about 8 mg/g β-Myrcene.
8 . The dosage form of claim 1 , wherein the cannabis component further comprises at least one of:
about 0.01 wt % to about 1.0 wt % cis-β-Farnesene,
about 0.01 wt % to about 1.0 wt % β-Caryophyllene,
about 0.005 wt % to about 0.5 wt % α-Pinene,
about 0.001 wt % to about 0.1 wt % α-Humulene,
about 0.001 wt % to about 0.1 wt % Linalool,
about 0.001 wt % to about 0.1 wt % Limonene,
about 0.01 wt % to about 1.0 wt % trans-Phytol,
about 0.01 wt % to about 1.0 wt % Terpinolene, or
about 0.01 wt % to about 1.0 wt % (−)-β-Pinene based on the total weight of the cannabis component.
9 . The dosage form of claim 1 , wherein the cannabis component further comprises at least one additional cannabinoid in an amount of, based on the total amount of the cannabis component, greater than 0 wt % to about 30 wt % based on the total weight of the composition or based on the total weight of the cannabis component.
10 . The dosage form of claim 1 , further comprising at least one of Tetrahydrocannabinolic acid (THCa), Δ 9 -tetrahydrocannabinol (Δ 9 -THC), Δ 9 -Tetrahydrocannabivarin (THCV), Cannabidiolic acid (CBDa), Cannabidiol (CBD), Cannabidivarin (CBDV), Cannabinol (CBN), Cannabigerolic Acid (CBGa), Cannabigerol (CBG), Cannabichromene (CBC), a prodrug thereof, a pharmaceutically acceptable salt thereof or combinations thereof.
11 . The dosage form of claim 1 , wherein the cannabis component further comprises, based on the total weight of the cannabis component, at least one of:
about 5 wt % to about 30 wt % Tetrahydrocannabinolic acid (THCa),
about 0.1 wt % to about 10 wt % Δ 9 -tetrahydrocannabinol (Δ 9 -THC),
about 0 wt % to about 1 wt % (THCV),
about 5 wt % to about 30 wt % Cannabidiolic acid (CBDa),
about 5 wt % to about 30 wt % Cannabidiol (CBD),
about 5 wt % to about 30 wt % Cannabidivarin (CBDV),
about 5 wt % to about 30 wt % Cannabinol (CBN),
about 5 wt % to about 30 wt % Cannabigerolic Acid (CBGa),
about 5 wt % to about 30 wt % Cannabigerol (CBG),
about 5 wt % to about 30 wt % Cannabichromene (CBC),
or
a prodrug of any of the foregoing, a pharmaceutically acceptable salt of any of the foregoing or combinations of combinations of the foregoing.
12 . A method of treating anxiety in a subject in need thereof, comprising: administering to the subject, a dosage form according to claim 1 .
13 . A method of treating depression in a subject in need thereof, comprising: administering to the subject, a dosage form according to claim 1 .
14 . A method of treating inflammation in a subject, comprising: administering to the subject, a dosage form according to claim 1 .
15 . A method of treating a neurological disorder in a subject, comprising:
administering to the subject, a dosage form according to claim 1 ,
wherein the neurological disorder is selected from the group consisting of post-traumatic stress disorder (PTSD) and Alzheimer's Disease.
16 . The dosage form from claim 1 , wherein when a combination of solid oral dosage forms is used, that the forms are administered by an aerosol or an inhaler.
17 . The dosage form from claim 1 , wherein the plasticizer is allyl glycolate, the bulking agent is mannitol, and the diluent is calcium sulfate dihydrate.