# US 11,077,086 B2 · Solid dosage form composition for buccal or sublingual administration of cannabinoids

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- Number: US 11,077,086 B2
- Document ID: US11077086B2
- Status: Granted
- Kind: B2
- Application number: 14/804,384
- Filed: 2015-07-21
- Published: 2016-01-21
- Granted: 2021-08-03
- Earliest claimed: 2014-07-21
- Assignees: Pharmaceutical Productions Inc.
- Applicants: Pharmaceutical Productions, Inc.
- Inventors: John A. McCarty
- Web page: https://patentgrep.com/patent/US11077086B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61J 3/007: {Marking tablets or the like (apparatus for printing on tablets or the like B41F17/36)}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the cannabinoid is THC.

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein the THC is present at from about 0.5 mg to about 50 mg.

### Claim 5 (depends on 3)

The pharmaceutical composition of claim 3, wherein the THC is present at from about 10 mg to about 30 mg.

### Claim 6 (depends on 1)

The pharmaceutical composition of claim 1, wherein the cannabinoid is CBD.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein the CBD is present at from about 0.5 mg to about 50 mg.

### Claim 8 (depends on 6)

The pharmaceutical composition of claim 6, wherein the CBD is present at from about 10 mg to about 30 mg.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

The pharmaceutical composition of claim 1, wherein the cannabinoid solution does not comprise an emulsifying agent.

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 13)

The pharmaceutical composition of claim 13, wherein the water-soluble diluent comprises mannitol.

### Claim 15 (depends on 13)

The pharmaceutical composition of claim 13, wherein the disintegrant comprises low-substituted hydroxypropyl cellulose.

### Claim 16 (depends on 13)

The pharmaceutical composition of claim 13, wherein the lubricant comprises sodium stearyl fumarate.

### Claim 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.

### Claim 18 (depends on 17)

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.