Compositions and dosage forms for oral delivery
The present disclosure provides pharmaceutical compositions comprising a cannabinoid, and dosage forms comprising same, for oral delivery, such as sublingual or buccal delivery. The compositions of the present disclosure are substantially homogeneous and remain stable and monophasic upon storage. Also provided are methods of using the compositions for pain management and to treat various diseases and conditions, including dementia, sleep disorders, movement disorders, mental disorders, and multiple sclerosis.
1. A spray comprising an oral liquid composition comprising about 0.025% w/w to about 40% w/w dronabinol or a pharmaceutical acceptable salt thereof, about 2% w/w to about 10% w/w of a hydrophobic solvent, about 30% w/w to about 60% w/w of an alcohol-based solvent, an optional co-solvent, about 0.5% of a film forming agent, and about 49% w/w to about 61% w/w of a propellant, wherein the composition is a single phase oral liquid composition which remains a single phase after two weeks of storage at 25° C. and is substantially anhydrous, and said spray is for oral application.
2. The spray of claim 1 , wherein the spray is for buccal application or sublingual application.
3. The spray of claim 1 , wherein the hydrophobic solvent is an oil-based solvent selected from the group of sesame oil, soybean oil, hydrogenated vegetable oil, and combinations thereof.
4. The spray of claim 1 , wherein the hydrophobic solvent is a C 5 -C 12 alkane solvent selected from the group of pentane, hexane, heptane, and combinations thereof.
5. The spray of claim 1 , wherein the alcohol-based solvent is selected from the group of ethanol, isopropanol, n-propanol, and combinations thereof.
6. The spray of claim 1 , wherein the co-solvent is present and selected from the group of benzyl alcohol, propylene glycol, dipropylene glycol, glycerol, dimethicone 350, dimethicone 1000, and combinations thereof.
7. The spray of claim 1 , wherein the film forming agent is a polymer selected from the group of polyvinyl pyrolidone, polyvinyl alcohol, acrylic polymers, acrylic copolymers, methacrylate polymers, methacrylate copolymers, polyvinyl acetate, cellulose based polymers, cellulose based copolymers, and combinations thereof.
8. The spray of claim 1 , wherein the film forming agent is a methacrylate copolymer.
9. The spray of claim 1 , wherein the film forming agent is a cationic copolymer of dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.
10. The spray of claim 1 , wherein the propellant is a hydrofluoroalkane selected from the group of 1,1,1,2-tetrafluoroethane (HFC-134a), 1,1,1,2,3,3,3-Heptafluoropropane (HFC-227), or a chlorofluorocarbon selected from CFC 11, CFC 12, and CFC 114, and combinations thereof.
11. A method of treating, ameliorating, or alleviating the symptoms of a disease, disorder or condition in a subject in need of such treatment, the method comprising administering to the subject a therapeutically effective amount of the spray of claim 1 , wherein the disease, disorder or condition is selected from pain, dementia, a sleep disorder, a movement disorder, a mental disorder, and multiple sclerosis.
12. The method of claim 11 , wherein the pain is migraine, neuropathic pain, or trigeminal pain.
13. The method of claim 11 , wherein the dementia is Alzheimer's disease or mild cognitive impairment.
14. The method of claim 11 , wherein the sleep disorder is sleep apnea or narcolepsy.
15. The method of claim 11 , wherein the movement disorder is Tourette's syndrome or Parkinson's disease.
16. The method of claim 11 , wherein the mental disorder is posttraumatic stress disorder.
17. The method of claim 11 , wherein the pain is migraine.
18. The method of claim 11 , wherein the dementia is Alzheimer's disease.
19. The method of claim 11 , wherein the spray is administered at least once a day.