Solid dosage form composition for buccal or sublingual administration of cannabinoids
The present invention relates to solid dosage forms of cannabinoid pharmaceutical formulations comprising a solvated cannabinoid for buccal or sublingual administration, and methods of making and using the same.
1. A pharmaceutical composition, comprising:
a pharmaceutically-acceptable adsorbent, and adsorbed thereto a cannabinoid solution comprising a mixture of ethanol and a cannabinoid selected from the group consisting of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD) and mixtures thereof; wherein
the pharmaceutical composition is a solid dosage form;
the solid dosage form is a tablet, powder, or film;
dissolution of the cannabinoid occurs within 300 seconds in 0.1 M phosphate buffer, pH 6.8, with 2% polysorbate 20;
the pharmaceutically-acceptable adsorbent is silica;
the cannabinoid is present in an amount from about 0.1 mg to about 150 mg; and
the weight/weight ratio of silica:cannabinoid solution is from about 1:0:0.5 to about 1.0:5.0; and
the cannabinoid solution in the solid dosage form comprises from about 5 wt % to about 95 wt % of ethanol by weight of the cannabinoid solution.
2. The pharmaceutical composition of claim 1 , wherein the silica is silicon dioxide, amorphous silica, hydrated silicon dioxide, fumed silica, colloidal silicon dioxide, magnesium aluminum silicate, magnesium silicate, calcium silicate, or a mixture thereof.
3. The pharmaceutical composition of claim 1 , wherein the cannabinoid is THC.
4. The pharmaceutical composition of claim 3 , wherein the THC is present at from about 0.5 mg to about 50 mg.
5. The pharmaceutical composition of claim 3 , wherein the THC is present at from about 10 mg to about 30 mg.
6. The pharmaceutical composition of claim 1 , wherein the cannabinoid is CBD.
7. The pharmaceutical composition of claim 6 , wherein the CBD is present at from about 0.5 mg to about 50 mg.
8. The pharmaceutical composition of claim 6 , wherein the CBD is present at from about 10 mg to about 30 mg.
9. The pharmaceutical composition of claim 1 , wherein the weight/weight ratio of silica:cannabinoid solution is from about 1.0:2.0 to about 1.0:3.0.
10. The pharmaceutical composition of claim 1 , wherein the weight/weight ratio of silica:cannabinoid solution is from about 1.0:1.0 to about 1.0:1.5.
11. The pharmaceutical composition of claim 1 , wherein the cannabinoid solution does not comprise an emulsifying agent.
12. The pharmaceutical composition of claim 1 , wherein the cannabinoid solution comprises from about 5 wt % to about 70 wt % of ethanol by weight of the cannabinoid solution.
13. The pharmaceutical composition of claim 1 , further comprising a water-soluble diluent, a disintegrant, a lubricant, or mixtures thereof.
14. The pharmaceutical composition of claim 13 , wherein the water-soluble diluent comprises mannitol.
15. The pharmaceutical composition of claim 13 , wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.
16. The pharmaceutical composition of claim 13 , wherein the lubricant comprises sodium stearyl fumarate.
17. A composition, comprising:
a solid dosage form of a pharmaceutically acceptable silica, and adsorbed thereto a solvated cannabinoid, the solvated cannabinoid consisting essentially of:
a cannabinoid; and
ethanol;
wherein the solvated cannabinoid in the solid dosage form is from about 5 wt % to about 95 wt % ethanol by weight of the solvated cannabinoid.
18. The composition of claim 17 , wherein the solvated cannabinoid is from about 5 wt % to about 70 wt % ethanol by weight of the solvated cannabinoid.