Claims for Patent: 7,141,237

Summary for Patent: 7,141,237

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), Hunt; Barry Thomas (Carnegie, AU)
Assignee:	Connetics Australia Pty Ltd. (Rowville, AU)
Application Number:	10/763,379
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,141,237
Patent Claims:	1. A topical delivery composition in a pressurized container, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C.sub.1 C.sub.6 alcohol, a C.sub.14 C.sub.22 alcohol, 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, a base; and wherein said composition is a quick-breaking temperature sensitive foam after release from said container. 2. The composition of claim 1, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is from about 1:7 to about 1:16. 3. The composition of claim 2, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is about 1:7. 4. The composition of claim 2, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is about 1:16. 5. The composition of claim 1, wherein the foam breaking temperature of said quick-breaking temperature sensitive foam is from about 30.degree. C. to about 36.degree. C. 6. The composition of claim 1, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is about 1.7:1. 7. The composition of claim 1, wherein said surfactant is present in an amount of from about 0.1% to about 10 % w/w. 8. The composition of claim 7, wherein said surfactant is selected from the group consisting of an ethoxylated non-ionic surfactant, an ethoxylated ionic surfactant, and a mixture thereof. 9. The composition of claim 7, wherein said surfactant is a polysorbate. 10. The composition of claim 1, further comprising an emollient. 11. The composition of claim 10, wherein said emollient is a polyol. 12. The composition of claim 11, wherein said polyol is selected from the group consisting of propylene glycol, glycerol, and a mixture thereof. 13. The composition of claim 1, wherein the amount of said C.sub.1 C.sub.6 alcohol in said quick-breaking foaming agent is from about 55% to about 65% w/w. 14. The composition of claim 13, wherein said C.sub.1 C.sub.6 alcohol is selected from the group consisting of methanol, ethanol, propanol, butanol, and a mixture thereof. 15. The composition of claim 14, wherein said C.sub.1 C.sub.6 alcohol is ethanol. 16. The composition of claim 14, wherein said C.sub.1 C.sub.6 alcohol is a mixture of ethanol and at least one other C.sub.1 C.sub.6 alcohol. 17. The composition of claim 1, wherein the amount of said C.sub.14 C.sub.22 alcohol in said quick-breaking foaming agent is from about 1% to about 5% w/w. 18. The composition of claim 17, wherein said C.sub.14 C.sub.22 alcohol is a C.sub.14 C.sub.20 alcohol. 19. The composition of claim 18, wherein said C.sub.14 C.sub.20 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof. 20. The composition of claim 19, wherein said C.sub.14 C.sub.20 alcohol is a mixture of cetyl alcohol and stearyl alcohol. 21. The composition of claim 20, wherein the ratio of cetyl alcohol to stearyl alcohol is from about 60:40 to about 80:20. 22. The composition of claim 21, wherein the ratio of cetyl alcohol to stearyl alcohol is about 70:30. 23. The composition of claim 1, wherein said composition comprises water in an amount up to 90% w/w. 24. The composition of claim 1, wherein said composition comprises water in an amount from about 30% to about 40% w/w. 25. The composition of claim 1 wherein the pH of said composition is from about pH 4.0 to about pH 9.0. 26. The composition of claim 1 wherein the pH of said composition is from about pH 4.0 to about pH 6.5. 27. The composition of claim 1, wherein said composition comprises: from about 0.1% to about 10% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking alcoholic foaming agent; and from about 2% to about 7% w/w of an aerosol propellant selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, and a mixture thereof. 28. A topical delivery composition in a pressurized container for the treatment of acne, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C.sub.1 C.sub.6 alcohol, a C.sub.14 C.sub.22 alcohol, water, and a surfactant; a base; 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 temperature sensitive foam after release from said container. 29. The composition of claim 1, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is from about 1.5:1 to about 1:16. 30. The composition of claim 29, wherein the ratio of said C.sub.1 C.sub.6 alcohol to water is about 1.6:1. 31. A topical delivery composition in a pressurized container, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C.sub.1 C.sub.6 alcohol, a C.sub.14 C.sub.22 alcohol, water, and a surfactant, wherein said C.sub.1 C.sub.6 alcohol is selected from the group consisting of methanol, ethanol, propanoL butanol, and a mixture thereof; a base; from about 2% to about 7% w/w of an aerosol propellant selected from the group consisting of a hydrocarbon, a chiorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof; and wherein said composition is a quick-breaking temperature sensitive foam after release from said container. 32. A topical delivery composition in a pressurized container for the treatment of a bacteria-mediated disease, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C.sub.1 C.sub.6 alcohol, a C.sub.14 C.sub.22 alcohol, water, and a surfactant, wherein said surfactant is present from 0% to 10% w/w; 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; a base; and wherein said composition is a quick-breaking temperature sensitive foam after release from said container. 33. A topical delivery composition in a pressurized container, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C.sub.1 C.sub.6 alcohol, a C.sub.14 C.sub.22 alcohol, water, and a surfactant; a base; an aerosol propellant selected from the group consisting of a hydrocarbon, a chiorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof, wherein the maximum amount of propellant is determined by its miscibility in said composition to form a homogeneous solution; and wherein said composition is a quick-breaking temperature sensitive foam after release from said container. 34. The composition of claims 1, 28, 31, 32 or 33, wherein said base is a member selected from the group consisting of a bicarbonate, a carbonate, an alkali hydroxide, an alkaline earth metal hydroxide, and a transition metal hydroxide. 35. The composition of claim 34, wherein said base is potassium hydroxide.