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 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.