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 pharmaceutical composition comprising about 0.25% w/w to about 2% w/w dronabinol, about 2% w/w to about 10% w/w of a hydrophobic solvent selected from the group consisting of sesame oil, soybean oil, hydrogenated vegetable oil, and combinations thereof, about 30% w/w to about 60% w/w of an alcohol-based solvent, an optional co-solvent, about 0.5% w/w of a film forming agent selected from a methacrylate copolymer and povidone, and about 49% w/w to about 61% w/w of a propellant, wherein the pharmaceutical composition is a single phase oral liquid pharmaceutical composition which remains a single phase after two weeks of storage at 25° C., and wherein the pharmaceutical composition is substantially anhydrous.
2. The pharmaceutical composition of claim 1 comprising:
a. about 0.8% w/w of dronabinol;
b. about 7.2% w/w of sesame oil;
c. about 40% w/w of isopropyl alcohol;
d. about 2.0% w/w of benzyl alcohol;
e. about 0.5% w/w of a methacrylate copolymer,
f. and about 49% w/w to about 61% w/w of a propellant.
3. The pharmaceutical composition of claim 1 comprising:
a. about 2.0% w/w of dronabinol;
b. about 2.2% w/w of sesame oil;
c. about 40% w/w of isopropyl alcohol;
d. about 2.0% w/w of propylene glycol;
e. about 0.5% w/w of a methacrylate copolymer,
f. and about 49% w/w to about 61% w/w of a propellant.
4. The pharmaceutical composition of claim 1 comprising:
a. about 0.25% w/w of dronabinol;
b. about 2.25% w/w of sesame oil;
c. about 40% w/w of isopropyl alcohol;
d. about 2.0% w/w of propylene glycol;
e. about 0.5% w/w of povidone,
f. and about 49% w/w to about 61% w/w of a propellant.
5. A pharmaceutical composition comprising about 0.25% w/w to about 2% dronabinol, about 2% w/w to about 10% w/w of a hydrophobic solvent selected from the group consisting of sesame oil, soybean oil, hydrogenated vegetable oil, and combinations thereof, about 30% w/w to about 60% w/w of an alcohol-based solvent, an optional co-solvent, and about 49% w/w to about 61% w/w of a propellant, wherein the pharmaceutical composition is a single phase oral liquid pharmaceutical composition which remains a single phase after two weeks of storage at 25° C., and wherein the pharmaceutical composition is free from film-forming agents and substantially anhydrous.
6. The pharmaceutical composition of claim 5 , wherein the co-solvent is present and is selected from the group of benzyl alcohol, propylene glycol, dipropylene glycol, glycerol, dimethicone 350, dimethicone 1000, and combinations thereof.
7. The pharmaceutical composition of claim 5 , wherein the co-solvent is present and is propylene glycol or benzyl alcohol.
8. The pharmaceutical composition of claim 5 , 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.
9. The pharmaceutical composition of claim 5 , wherein said hydrophobic solvent is present at about 2% w/w to about 10% w/w, said alcohol-based solvent is present at about 30% w/w to about 60% w/w, and said co-solvent is present at about 0.5% w/w to about 5% w/w of the pharmaceutical composition.
10. The pharmaceutical compositions of claim 5 , further comprising a flavorant.
11. A spray comprising the pharmaceutical composition of claim 5 , wherein said spray is for oral application.
12. The pharmaceutical composition of claim 5 , wherein the composition remains stable upon storage for at least two years at about 4° C., or at least one month at room temperature.
13. The pharmaceutical composition of claim 5 comprising:
a. about 2.0% w/w of dronabinol;
b. about 2.2% w/w of sesame oil;
c. about 40% w/w of isopropyl alcohol;
d. about 2.0% w/w of propylene glycol,
e. and about 49% w/w to about 61% w/w of a propellant.
14. A single phase pharmaceutical composition comprising:
a. about 0.25% w/w to about 2% of w/w dronabinol or a pharmaceutically acceptable salt thereof,
b. about 2% w/w to about 10% w/w of sesame oil;
c. about 30% w/w to about 60% w/w of isopropanol;
d. about 0.5% w/w to about 5% w/w of a co-solvent selected from propylene glycol or benzyl alcohol,
e. and about 49% w/w to about 61% w/w of 1,1,1,2-tetrafluoroethane, wherein the pharmaceutical composition remains a single phase after two weeks of storage at 25° C.