# US 2012/0074026 A1 · Pharmaceutical foam > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2012/0074026 A1 - Document ID: US20120074026A1 - Status: Published application - Kind: A1 - Application number: 13/307,533 - Filed: 2011-11-30 - Published: 2012-03-29 - Earliest claimed: 2003-01-24 - Assignees: Stiefel Research Australia Pty Ltd - Inventors: Albert Zorko ABRAM; Lilian FUCHSHUBER - Web page: https://patentgrep.com/patent/US20120074026A1 ## CPC - A61K 8/046: {Aerosols; Foams} - A61K 8/38: Percompounds, e.g. peracids - A61K 8/671: {Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal} - A61K 9/12: Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)} - A61K 9/122: {Foams; Dry foams (edible foams A61K9/0056)} - A61K 31/4025: not condensed and containing further heterocyclic rings, e.g. cromakalim - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 17/00: Drugs for dermatological disorders - A61P 17/10: Anti-acne agents - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/04: Antibacterial agents - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61Q 19/00: Preparations for care of the skin - 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 - A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS ## Abstract The present invention provides various pharmaceutically active topical delivery compositions. In particular, compositions of the present invention are present in a pressurized container comprising a quick-breaking alcoholic foaming agent, such that when the composition is released, i.e., dispensed, from the pressurized container, a quick-breaking temperature sensitive foam is formed. In addition, the present invention provides various aspects related to such compositions, including methods for modulating a foam characteristic, methods for improving the shelf-life of a pharmaceutically active compound, methods for the percutaneous treatment of various diseases, infections, and illnesses, and methods for evaluating foam characteristics. ## Claims ### Claim 1 A topical delivery foam composition in a pressurized container, said composition comprising: up to 15% of at least one pharmaceutically active agent, wherein the at least one pharmaceutically active agent comprises a combination of benzoyl peroxide and clindamycin or a salt or ester thereof; from about 83% to about 97.9% w/w of a quick-breaking foaming agent comprising water and a surfactant; and from about 2% to about 7% w/w of an aerosol propellant selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof, wherein said composition is a quick-breaking foam after release from said container, and wherein said quick-breaking foaming agent comprises about 80% to about 95% w/w water and about 0% of a C1-C6 alcohol, based on the total weight of the composition. ### Claim 2 (depends on 1) The topical delivery foam composition of claim 1, wherein said clindamycin is clindamycin phosphate. ### Claim 3 (canceled) ### Claim 4 (depends on 1) The topical delivery foam composition of claim 1, wherein said surfactant is selected from the group consisting of a block co-polymer, fatty acid ethoxylates, fatty alcohol ethoxylates, polysorbates and glycerol ester ethoxylates. ### Claim 5 (depends on 4) The topical delivery foam composition of claim 4, wherein said surfactant is a block co-polymer. ### Claim 6 (depends on 5) The topical delivery foam composition of claim 5, wherein said block co-polymer is a poloxamer. ### Claim 7 (depends on 1) The topical delivery foam composition of claim 1, wherein said surfactant is selected from the group consisting of Polysorbate 20, Polysorbate 60, Polysorbate 80, Laureth-4, Laureth-23, POE(15) glycerol monolaurate, and mixtures thereof. ### Claim 8 (depends on 1) The topical delivery foam composition of claim 1, wherein said surfactant is present in an amount of from about 0.1% to about 10% w/w. ### Claim 9 (depends on 8) The topical delivery foam composition of claim 8, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w. ### Claim 10 (depends on 1) The topical delivery foam composition of claim 1, wherein said quick-breaking foaming agent further comprises a pH adjusting agent. ### Claim 11 (depends on 10) The topical delivery foam composition of claim 10, wherein said pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to between about 4.0 to about 6.5. ### Claim 12 (depends on 10) The topical delivery foam composition of claim 10, wherein said pH adjusting agent is a buffer. ### Claim 13 (depends on 12) The topical delivery foam composition of claim 12, wherein said buffer is selected from the group consisting of citrate/citric acid, acetate/acetic acid, phosphate/phosphoric acid, formate/formic acid, propionate/propionic acid, lactate/lactic acid, carbonate/carbonic acid and ammonium/ammonia buffer. ### Claim 14 (depends on 1) The topical delivery foam composition of claim 1, wherein said quick-breaking foaming agent contains about 0% of an emollient. ### Claim 15 (depends on 1) The topical delivery foam composition of claim 1, wherein said composition further comprises xanthan gum. ### Claim 16 A topical delivery foam composition in a pressurized container, said composition comprising: benzoyl peroxide and clindamycin or a salt or ester thereof; a quick-breaking foaming agent comprising: a) water present in an amount from about 80% to about 95% w/w based on the total weight of the composition, and b) a surfactant, wherein the quick-breaking foaming agent contains about 0% of a C1-C6 alcohol based on the total weight of the composition; and an aerosol propellant selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof, wherein said composition is a quick-breaking foam after release from said container. ### Claim 17 (depends on 16) The topical delivery foam composition of claim 16, wherein said surfactant is selected from the group consisting of a block copolymer, fatty acid ethoxylates, fatty alcohol ethoxylates, polysorbates and glycerol ester ethoxylates. ### Claim 18 (depends on 16) The topical delivery foam composition of claim 16, wherein said surfactant is selected from the group consisting of Polysorbate 20, Polysorbate 60, Polysorbate 80, Laureth-4, Laureth-23, POE(15) glycerol monolaurate, and mixtures thereof. ### Claim 19 (depends on 16) The topical delivery foam composition of claim 16, wherein said surfactant is present in an amount of from about 0.1% to about 10% w/w. ### Claim 20 (depends on 19) The topical delivery foam composition of claim 19, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w. ### Claim 21 (depends on 16) The topical delivery foam composition of claim 16, wherein said quick-breaking foaming agent further comprises a pH adjusting agent. ### Claim 22 (depends on 21) The topical delivery foam composition of claim 21, wherein said pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to between about 4.0 to about 6.5. ### Claim 23 (depends on 21) The topical delivery foam composition of claim 21, wherein said pH adjusting agent is selected from the group consisting of a base and a buffer. ### Claim 24 (depends on 23) The topical delivery foam composition of claim 23, wherein said pH adjusting agent is a buffer. ### Claim 25 (depends on 24) The topical delivery foam composition of claim 24, wherein said buffer is selected from the group consisting of citrate/citric acid, acetate/acetic acid, phosphate/phosphoric acid, formate/formic acid, propionate/propionic acid, lactate/lactic acid, carbonate/carbonic acid and ammonium/ammonia buffer. ### Claim 26 (depends on 25) The topical delivery foam composition of claim 25, wherein said buffer is citrate/citric acid. ### Claim 27 (depends on 16) The topical delivery foam composition of claim 16, wherein said quick-breaking foaming agent contains about 0% of an emollient. ### Claim 28 (depends on 16) The topical delivery foam composition of claim 16, wherein said composition further comprises xanthan gum. ### Claim 29 (depends on 21) The topical delivery foam composition of claim 21, wherein said composition further comprises xanthan gum. ### Claim 30 (depends on 1) The topical delivery foam composition of claim 1, wherein said aerosol propellant is a hydrocarbon propellant. ### Claim 31 (depends on 16) The topical delivery foam composition of claim 16, wherein said aerosol propellant is a hydrocarbon propellant.