IP Library Patent Application 17363056
Patent Application
App. No. 17/363,056

SOLID DOSAGE FORM COMPOSITION FOR BUCCAL OR SUBLINGUAL ADMINISTRATION OF CANNABINOIDS

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Quick Facts
Patent No.
US None
App. No.
17/363,056
Abstract

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.

Claims (34)

1 . A pharmaceutical composition in a solid dosage form for sublingual or buccal administration, comprising:

a cannabinoid;

a pharmaceutically-acceptable solvent into which the cannabinoid is solvated; and

a pharmaceutically-acceptable adsorbent onto which the solvated cannabinoid is adsorbed.

2 . The composition of claim 1 , wherein the solvent comprises polyethylene glycol, ethanol, substituted polyethylene glycols, propylene glycol, propylene carbonate, or a mixture thereof.

3 . The composition of claim 2 , wherein the solvent comprises ethanol.

4 . The composition of claim 1 , wherein the adsorbent comprises silica, microcrystalline cellulose, cellulose, silicified microcrystalline cellulose, clay, talc, starch, pregelatinized starch, calcium carbonate, dicalcium phosphate, magnesium carbonate, and mixtures thereof.

5 . The composition of claim 4 , wherein the pharmaceutically acceptable adsorbent comprises silica.

6 . The pharmaceutical composition of claim 5 , 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.

7 . The composition of claim 1 , wherein the cannabinoid comprises delta-9-tetrahydrocannabinol (THC).

8 . The composition of claim 7 , wherein the THC is present at from about 0.5 mg to about 50 mg.

9 . The composition of claim 7 , wherein the THC is present at from about 10 mg to about 30 mg.

10 . The composition of claim 1 , wherein the cannabinoid comprises cannabidiol (CBD).

11 . The composition of claim 10 , wherein the CBD is present at from about 0.5 mg to about 50 mg.

12 . The composition of claim 11 , wherein the CBD is present at from about 10 mg to about 30 mg.

13 . The composition of claim 4 , wherein the weight/weight ratio of silica:cannabinoid solution is from about 1:0.5 to about 1:5.

14 . The composition of claim 1 , further comprising a water-soluble diluent, a disintegrant, a lubricant, or mixtures thereof.

15 . The composition of claim 14 , wherein the water-soluble diluent comprises mannitol.

16 . The method of claim 14 , wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.

17 . The method of claim 14 , wherein the lubricant comprises sodium stearyl fumarate.

18 . The pharmaceutical composition of claim 1 , which is in the form of a tablet or film.

19 . A method for preparing a pharmaceutical composition comprising a solvated cannabinoid in a solid dosage form for sublingual or buccal administration having increased oral bioavailability and shortened onset of action of the cannabinoid, the method comprising:

solvating the cannabinoid in a pharmaceutically acceptable solvent to form a solvated cannabinoid;

mixing the solvated cannabinoid with an adsorbent, onto which the solvated cannabinoid is adsorbed; and

processing the solvated cannabinoid/adsorbent into a solid dosage form.

20 . The method of claim 19 , wherein the cannabinoid comprises THC or CBD.

21 . The method of claim 19 , wherein the adsorbent comprises silica.

22 . The method of claim 19 , wherein the solvent comprises ethanol.

23 . The method of claim 19 , wherein the excipient added is a lubricant, a water-soluble diluent, a disintegrant, or a mixture thereof.

24 . The method of claim 23 , wherein the lubricant comprises sodium stearyl fumarate.

25 . The method of claim 23 , wherein the water-soluble diluent comprises mannitol.

26 . The method of claim 23 , wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.

27 . The method of claim 23 , further comprising processing the solvated cannabinoid/adsorbent composition into a tablet.

28 . A pill pack comprising the cannabinoid composition of claim 1 encased within a packaging enclosure.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 10, 2021
From: MCCARTY, JOHN A.
To: PHARMACEUTICAL PRODUCTIONS, INC.
Reel/Frame 057130/0194 →