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Details for Patent: 8,586,008

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Details for Patent: 8,586,008

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, New Castle, DE)
Filing Date:Nov 30, 2011
Application Number:13/307,533
Claims:1. A topical delivery foam composition in a pressurized container, said composition comprising: up to 15% w/w based on the total weight of the composition 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 based on the total weight of the composition of an aqueous quick-breaking foaming agent comprising 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, wherein the aqueous quick-breaking foaming agent does not contain a C.sub.1-C.sub.6 alcohol; and from about 2% to about 7% w/w based on the total weight of the composition 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 3, wherein said surfactant is a block co-polymer.

5. The topical delivery foam composition of claim 4, wherein said block co-polymer is a poloxamer.

6. 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.

7. 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 based on the total weight of the composition.

8. The topical delivery foam composition of claim 7, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w based on the total weight of the composition.

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

10. The topical delivery foam composition of claim 9, 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.

11. The topical delivery foam composition of claim 1, wherein said aqueous quick-breaking foaming agent contains about 0% w/w of an emollient based on the total weight of the composition.

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

13. A topical delivery foam composition in a pressurized container, said composition comprising: benzoyl peroxide and clindamycin or a salt or ester thereof; an aqueous quick-breaking foaming agent comprising: 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, wherein the aqueous quick-breaking foaming agent does not contain a C.sub.1-C.sub.6 alcohol; 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.

14. The topical delivery foam composition of claim 13, wherein said surfactant is selected from the group consisting of a block copolymer, fatty acid ethoxylates, fatty alcohol ethoxylates, polysorbates and glycerol ester ethoxylates.

15. The topical delivery foam composition of claim 13, 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.

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

17. The topical delivery foam composition of claim 16, wherein said surfactant is present in an amount of from about 0.1% to about 6% w/w based on the total weight of the composition.

18. The topical delivery foam composition of claim 13, wherein said pH adjusting agent is selected from the group consisting of a base and a buffer.

19. The topical delivery foam composition of claim 18, wherein said pH adjusting agent is a buffer.

20. The topical delivery foam composition of claim 19, 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.

21. The topical delivery foam composition of claim 20, wherein said buffer is citrate/citric acid.

22. The topical delivery foam composition of claim 13, wherein said aqueous quick-breaking foaming agent contains about 0% w/w of an emollient based on the total weight of the composition.

23. The topical delivery foam composition of claim 13, wherein said composition further comprises xanthan gum.

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

25. The topical delivery foam composition of claim 13, wherein said aerosol propellant is a hydrocarbon propellant.

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

27. The topical delivery foam composition of claim 13, wherein the water is present in an amount of about 80% to about 95% w/w based on the total weight of the composition.
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