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|Abstract:||The present invention provides various pharmaceutically active topical delivery compositions. In particular, compositions of the present invention are present in a pressurized contained 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:||Stiefel Research Australia, Pty Ltd. (Rowville, AU)|
1. A method for treating a bacteria-mediated disease, said method comprising: applying a quick-breaking temperature sensitive foam composition to the skin of a subject in
need thereof, 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-C22
alcohol, water, and a surfactant; 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; and a base, to treat said
2. The method 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.
3. The method 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.
4. The method of claim 1, wherein the ratio of said C.sub.1-C.sub.6 alcohol to water is less than about 1:7.
5. The method of claim 1, wherein the ratio of said C.sub.1-C.sub.6 alcohol to water is about 1.5:1 to about 1.8:1.
6. The method of claim 1, wherein the ratio of said C.sub.1-C.sub.6 alcohol to water is about 1.55:1 to about 1.75:1.
7. The method of claim 1, wherein the ratio of said C.sub.1-C.sub.6 alcohol to water is from about 1.5:1.
8. The method of claim 1, wherein said surfactant is present in an amount of from about 0.1% to about 10% w/w.
9. The method of claim 1, wherein said surfactant is selected from the group consisting of an ethoxylated non-ionic surfactant, an ethoxylated ionic surfactant, and a mixture thereof.
10. The method of claim 1, wherein said C.sub.1-C.sub.6 alcohol is ethanol.
11. The method of claim 1, 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.
12. The method 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.
13. The method of claim 12, wherein said C.sub.14-C.sub.22 alcohol is a C.sub.14-C.sub.20 alcohol.
14. The method of claim 13, wherein said C.sub.14-C.sub.20 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof.
15. The method of claim 14, wherein said C.sub.14-C.sub.20 alcohol is a mixture of cetyl alcohol and stearyl alcohol.
16. The method of claim 1, wherein said surfactant is a polysorbate.
17. The method of claim 1, further comprising an emollient.
18. The method of claim 1, 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.
19. The method of claim 18, wherein said base wherein said base is potassium hydroxide.
20. The method of claim 1, wherein said bacteria-mediated disease is acne vulgaris.
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