# US 9,517,219 B2 · Topical dapsone and dapsone/adapalene compositions and methods for use thereof

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- Number: US 9,517,219 B2
- Document ID: US9517219B2
- Status: Granted
- Kind: B2
- Application number: 14/885,805
- Filed: 2015-10-16
- Published: 2016-02-04
- Granted: 2016-12-13
- Earliest claimed: 2012-11-20
- Assignees: Allergan, Inc.
- Applicants: Allergan, Inc.
- Inventors: Kevin S. Warner; Ajay P. Parashar; Vijaya Swaminathan; Varsha Bhatt
- Web page: https://patentgrep.com/patent/US9517219B2

## CPC

- A61K 31/136: having the amino group directly attached to the aromatic ring, e.g. benzeneamine
- 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 31/145: having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2) (isothiourea A61K31/155)
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/04: Antipruritics
- A61P 17/08: Antiseborrheics
- A61P 17/10: Anti-acne agents
- A61P 17/12: Keratolytics, e.g. wart or anti-corn preparations
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Dapsone and dapsone/adapalene compositions can be useful for treating a variety of dermatological conditions. The compositions of this disclosure include dapsone and/or adapalene in a polymeric viscosity builder. Subject compositions can be adjusted to optimize the dermal delivery profile of dapsone to effectively treat dermatological conditions and improve the efficiency of pharmaceutical products applied to the skin. Use of the polymeric viscosity builder provides compositions with increased concentrations of diethylene glycol monoethyl ether relative to compositions without the polymeric viscosity builder.

## Claims

### Claim 1

A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea comprising administering to a subject having the dermatological condition selected from the group consisting of acne vulgaris and rosacea a topical pharmaceutical composition comprising:
about 7.5% w/w dapsone;
about 30% w/w to about 40% w/w diethylene glycol monoethyl ether;
about 2% w/w to about 6% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and
water;
wherein the topical pharmaceutical composition does not comprise adapalene.

### Claim 2 (depends on 1)

The method of claim 1, wherein the diethylene glycol monoethyl ether is present at a concentration of about 30% w/w.

### Claim 3 (depends on 1)

The method of claim 1, wherein the polymeric viscosity builder is present at a concentration of about 4% w/w.

### Claim 4 (depends on 1)

The method of claim 1, wherein the topical pharmaceutical composition further comprises methyl paraben.

### Claim 5 (depends on 1)

The method of claim 1 wherein the dermatological condition is acne vulgaris.

### Claim 6

A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea comprising administering to a subject having the dermatological condition selected from the group consisting of acne vulgaris and rosacea a topical pharmaceutical composition comprising:
about 7.5% w/w dapsone;
about 30% w/w diethylene glycol monoethyl ether;
about 4% w/w of a polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer; and
water;
wherein the topical pharmaceutical composition does not comprise adapalene.

### Claim 7 (depends on 6)

The method of claim 6, wherein the topical pharmaceutical composition further comprises methyl paraben.

### Claim 8 (depends on 6)

The method of claim 6 wherein the dermatological condition is acne vulgaris.