Pharmaceutical foam
View Patent ↗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.
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 1 -C 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 1 -C 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.