PHARMACEUTICAL FOAM
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 - 3 . (canceled)
4 . A topical delivery composition in a pressurized container, said composition comprising:
clindamycin or a salt or ester thereof and a retinoid or derivative thereof;
a quick-breaking foaming agent comprising:
a) water present in an amount from about 80% to about 95% by weight,
b) a surfactant, and
c) a pH adjusting agent, wherein the quick-breaking foaming agent contains about 0% of 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,
and wherein said composition is a quick-breaking foam after release from said container.
5 . The composition of claim 4 , wherein the clindamycin or a salt or ester thereof is clindamycin phosphate.
6 . The composition of claim 4 , where the retinoid or derivative thereof is selected from the group consisting of tretinoin, tazarotene and adapalene.
7 . The composition of claim 6 , where the retinoid or derivative thereof is tretinoin.
8 . The composition of claim 4 , wherein the surfactant is selected from the group consisting of a block co-polymer, fatty acid ethoxylates, fatty alcohol ethoxylates, polysorbates and glycerol ester ethoxylates, and mixtures thereof.
9 . The composition of claim 8 , wherein the surfactant is a block copolymer.
10 . The composition of claim 9 , wherein the block copolymer is a poloxamer.
11 . The composition of claim 8 , wherein the surfactant is a fatty alcohol ethoxylate.
12 . The composition of claim 11 , wherein the fatty alcohol ethoxylate is Laureth-4.
13 . The composition of claim 8 , wherein the surfactant is a mixture of Laureth-4 and POE (15) glyceryl monolaurate.
14 . The composition of claim 4 , wherein the surfactant is present in an amount from about 0.1% to about 10% by weight.
15 . The composition of claim 14 , wherein the surfactant is present in an amount from about 0.5% to about 5% by weight.
16 . The composition of claim 4 , wherein the pH adjusting agent is a buffer, acid or base.
17 . The composition of claim 16 , wherein the pH adjusting agent is a buffer.
18 . The composition of claim 17 , wherein the 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.
19 . The composition of claim 18 , wherein the buffer is citrate/citric acid.
20 . The composition of claim 16 , wherein the pH adjusting agent is an acid.
21 . The composition of claim 20 , wherein the acid is citric acid.
22 . The composition of claim 4 , wherein the pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to between about 4.0 to about 6.5.
23 . The composition of claim 4 , wherein the composition further comprises a polyol.
24 . The composition of claim 23 , wherein the polyol is selected from the group consisting of propylene glycol and glycerol.
25 . The composition of claim 23 , wherein the polyol is present in an amount from about 2% to about 7.5% by weight.