# US 11,896,560 B2 · Cannabinoid dosing regime for dermatitis and inflammatory skin conditions

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- Number: US 11,896,560 B2
- Document ID: US11896560B2
- Status: Granted
- Kind: B2
- Application number: 16/964,791
- Filed: 2019-01-24
- Published: 2021-02-25
- Granted: 2024-02-13
- Earliest claimed: 2018-01-24
- Assignees: Botanix Pharmaceuticals Ltd.
- Applicants: Botanix Pharmaceuticals LTD
- Inventors: Matthew Callahan; Michael Thurn
- Web page: https://patentgrep.com/patent/US11896560B2

## CPC

- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A treatment regime for use in the treatment or prevention of dermatitis and inflammatory skin conditions, said regime comprising the administration of: a) between 50 mg and 3000 mg of a topical liquid or gel composition comprising between 1% w/w and 15% w/w cannabinoid, wherein the cannabinoid is dissolved in the liquid or gel composition.

## Claims

### Claim 1

A treatment regime for use in the treatment of dermatitis and inflammatory skin conditions, said regime comprising the administration of:
between 50 mg and 3000 mg of a topical liquid or gel composition comprising between 1% w/w and 15% w/w cannabidiol, 85% w/w and 95% w/w of hexamethyldisiloxane, octamethyltrisiloxane or combinations thereof, and between 1% w/w and 10% w/w of a residual solvent that is less volatile than hexamethyldisiloxane, octamethyltrisiloxane or combinations thereof such that less than 5% of the residual solvent evaporates at skin temperature over 24 hours and wherein the residual solvent is selected from fatty acids, fatty acid alcohols, fatty alcohols, glycols or alkanes, or ethers of any of these, wherein the cannabidiol is dissolved in the liquid or gel composition, and the total daily dose applied to the skin is between 20 mg and 2000 mg cannabidiol.

### Claim 2 (depends on 1)

The treatment regime of claim 1, wherein the topical composition is administered to the skin between 1 and 5 times per day.

### Claim 3 (depends on 1)

The treatment regime of claim 1, wherein the topical composition delivers between 20 mg and 400 mg of cannabidiol per administration.

### Claim 4 (depends on 1)

The treatment regime of claim 1 wherein:
the topical composition comprises 4% w/w cannabidiol.

### Claim 5 (depends on 1)

The treatment regime of claim 1, wherein the topical composition comprises 1-10% wt/wt C2-C6 alcohol.

### Claim 6 (depends on 1)

The treatment regime of claim 1, wherein the topical composition comprises 85% w/w and 95% w/w hexamethyldisiloxane.

### Claim 7 (depends on 1)

The treatment regime of claim 1, wherein the residual solvent is a compound selected from the group consisting of: alkyl polypropylene glycol, polyethylene glycol ether, oleyl alcohol, isostearyl alcohol, octyldodecyl alcohol, 2-hexyl decyl alcohol, isohexadecane.

### Claim 8 (depends on 1)

The treatment regime of claim 1 wherein the regime delivers 180 mg of cannabidiol per day.

### Claim 9 (depends on 1, 2, 3, 4, 5, 6, 7, 8)

The treatment regime of any of claims 1-3, 4, 5, 6, 7 and 8 for use in the treatment of dermatitis.

### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8)

The treatment regime of any of claims 1-3, 4, 5, 6, 7 and 8 for use in the treatment of atopic dermatitis.