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Last Updated: March 29, 2024

Details for Patent: 9,486,394


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Title:Pharmaceutical foam
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.
Inventor(s): Abram; Albert Zorko (Wantirna, AU), Fuchshuber; Lilian (Narre Warren, AU)
Assignee: STIEFEL WEST COAST, LLC (Wilmington, DE)
Filing Date:Oct 14, 2013
Application Number:14/053,085
Claims:1. A topical delivery foam composition in a pressurized container, said composition consisting essentially of, with respect to the total weight of the composition: up to 15% w/w 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 an aqueous quick-breaking foaming agent consisting essentially of water, a surfactant, and a pH adjusting agent present in an amount sufficient to adjust the pH of the composition to between about 4.0 to about 6.5; 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.

2. The topical delivery foam composition of claim 1, wherein said clindamycin is clindamycin phosphate.

3. 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.

4. 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.

5. The topical delivery foam composition of claim 4, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w.

6. The topical delivery foam composition of claim 1, wherein said pH adjusting agent is a buffer.

7. The topical delivery foam composition of claim 6, 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.

8. The topical delivery foam composition of claim 1, wherein said aerosol propellant is a hydrocarbon propellant.

9. The topical delivery foam composition of claim 1, wherein the water is present in an amount of about 80% to about 95% w/w.

10. The topical delivery foam composition of claim 1, wherein said composition further comprises xanthan gum.

11. A topical delivery foam composition in a pressurized container, said composition consisting essentially of: benzoyl peroxide and clindamycin or a salt or ester thereof; an aqueous quick-breaking foaming agent consisting essentially of: a) water, b) a surfactant, and c) a pH adjusting agent present in an amount sufficient to adjust the pH of the composition to between about 4.0 to about 6.5; 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.

12. The topical delivery foam composition of claim 11, wherein said surfactant is selected from the group consisting of a block copolymer, fatty acid ethoxylates, fatty alcohol ethoxylates, polysorbates and glycerol ester ethoxylates.

13. The topical delivery foam composition of claim 11, wherein said surfactant is present in an amount of from about 0.1% to about 10% w/w with respect to the total weight of the composition.

14. The topical delivery foam composition of claim 13, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w with respect to the total weight of the composition.

15. The topical delivery foam composition of claim 11, wherein said pH adjusting agent is a buffer.

16. The topical delivery foam composition of claim 15, 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.

17. The topical delivery foam composition of claim 16, wherein said buffer is citrate/citric acid.

18. The topical delivery foam composition of claim 11, wherein said aerosol propellant is a hydrocarbon propellant.

19. The topical delivery foam composition of claim 11, wherein the water is present in an amount of about 80% to about 95% w/w with respect to the total weight of the composition.

20. The topical delivery foam composition of claim 11, wherein said composition further comprises xanthan gum.

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