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.

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.