Mousse composition

Abstract

A pharmaceutical aerosol foam composition including an effective amount of a pharmaceutically active ingredient; an occlusive agent; an aqueous solvent; and an organic cosolvent, the pharmaceutically active ingredient being insoluble in both water and the occlusive agent; the occlusive agent being present in an amount sufficient to form an occlusive layer on the skin, in use.

1 . A method for increasing skin permeability of an active agent, said method comprising: 
 applying a topical mousse composition comprising 
 (a) an occlusive agent;  
 (b) an aqueous solvent;  
 (c) an organic cosolvent; and  
 (d) an active agent, wherein the occlusive agent is present in an amount sufficient to form an occlusive layer on the skin to increase skin permeability of said active agent.  
   
   
   
       2 . A method for reducing trans epidermal water loss with the topical application of an active agent, said method comprising: 
 applying a topical mousse composition comprising 
 (a) an occlusive agent;  
 (b) an aqueous solvent;  
 (c) an organic cosolvent; and  
 (d) an active agent, where after application of said composition, trans epidermal water loss is reduced.  
   
   
   
       3 . A method for topical application of an active agent, said method comprising: 
 applying a topical mousse composition comprising 
 (a) an occlusive agent;  
 (b) an aqueous solvent;  
 (c) an organic cosolvent; and  
 (d) an active agent.  
   
   
   
       4 . The method according to claims  1  or  2  or  3 , wherein the occlusive agent comprises petrolatum.  
   
   
       5 . The method according to claims  1  or  2  or  3 , wherein the occlusive agent further comprises a mineral oil and a long chain acid.  
   
   
       6 . The method according to claims  1  or  2  or  3 , wherein the occlusive agent is selected from the group consisting of a mineral oil and grease, a long chain acid, an animal fat and grease, a vegetable fat and grease, and a water insoluble polymer.  
   
   
       7 . The method according to  claim 6 , wherein the occlusive agent is an animal fat or animal grease.  
   
   
       8 . The method according to claims  1  or  2  or  3  wherein the occlusive agent is present in an amount of approximately 55% by weight or less, based on the total weight of the composition.  
   
   
       9 . The method according to  claim 8 , wherein the occlusive agent is present in an amount of approximately 10 to 50% by weight, based on the total weight of the composition.  
   
   
       10 . The method according to claims  1  or  2  or  3 , further comprising an effective amount of an emulsifier component.  
   
   
       11 . The method according to  claim 10 , wherein the emulsifier component is present in an amount of from approximately 1% to 15% by weight, based on the total weight of the composition.  
   
   
       12 . The method according to  claim 11 , wherein the emulsifier component is present in an amount of from approximately 2% to 5% by weight, based on the total weight of the composition.  
   
   
       13 . The method according to  claim 10 , wherein the emulsifier component is selected from the group consisting of a non-ionic surfactant, a cationic surfactant, an anionic surfactant, a fatty alcohol, a fatty acid, and fatty acid salts thereof.  
   
   
       14 . The method according to  claim 10 , wherein the emulsifier component comprises a mixture of a sorbitan ester and a polyoxyethylene fatty alcohol ether.  
   
   
       15 . The method according to  claim 10 , wherein the emulsifier component comprises a fatty alcohol, a fatty acid or a fatty acid salt.  
   
   
       16 . The method according to claims  1  or  2  or  3 , wherein the aqueous solvent is present in an amount of approximately 25 to 95% by weight, based on the total weight of the composition.  
   
   
       17 . The method according to claims  1  or  2  or  3 , wherein the organic cosolvent is present in an amount of approximately 0.25% by weight to 50% by weight, based on the total weight of the composition.  
   
   
       18 . The method according to  claim 17 , wherein the organic cosolvent is present in an amount of approximately 0.5% by weight to 2.0% by weight, based on the total weight of the composition.  
   
   
       19 . The method according to claims  1  or  2  or  3 , wherein the organic cosolvent comprises an ester of a fatty acid.  
   
   
       20 . The method according to claims  1  or  2  or  3 , wherein the organic cosolvent is selected from the group consisting of a medium to long chain alcohol, an aromatic and/or alkyl pyrollidinone, an aromatic and/or alkyl, and/or cyclic ketone, an aromatic and/or alkyl, and/or cyclic ether, substituted and/or unsubstituted single or multiple ring aromatic, straight chain and/or branched chain and/or cyclic alkane or silicone.  
   
   
       21 . The method according to claims  1  or  2  or  3 , further comprising an effective amount of an aerosol propellant.  
   
   
       22 . The method according to  claim 21 , wherein the aerosol propellant is a hydrocarbon and is present in an amount of approximately 2.5 to 20% by weight, based on the total weight of the composition.  
   
   
       23 . The method according to claims  1  or  2  or  3  wherein said active agent is selected from the group consisting of an analgesic, an antifungal, an antibacterial, an anesthetic, an antiviral, an antipruritic, an antihistamine, a xanthine, a sex hormone, an anti-inflammatory, and a corticosteroid.  
   
   
       24 . The method according to  claim 23 , wherein said active agent is an anti-inflammatory.  
   
   
       25 . The method according to  claim 23 , wherein the active agent is insoluble in water.  
   
   
       26 . The method according to  claim 23 , wherein the active agent is insoluble in the occlusive agent.  
   
   
       27 . The method according to  claim 23 , wherein the active agent is insoluble in both water and the occlusive agent.  
   
   
       28 . The method according to  claim 23 , wherein the pharmaceutically active ingredient is present in an amount of from approximately 0.005% by weight to approximately 10% by weight, based on the total weight of the composition.  
   
   
       29 . The method according to  claim 23 , wherein the pharmaceutically active ingredient is present in an amount of from approximately 0.05% by weight to approximately 1% by weight, based on the total weight of the composition.  
   
   
       30 . The method according to  claim 23 , wherein said active agent is a corticosteroid.  
   
   
       31 . The method according to  claim 23  or  30 , wherein said active agent is more than one active agent.  
   
   
       32 . The method according to  claim 30 , wherein said corticosteroid is a member selected from the group consisting of betamethasone valerate and clobetasol propionate.  
   
   
       33 . The method according to  claim 23 , wherein said active agent is an antibacterial agent.  
   
   
       34 . The method according to  claim 33 , wherein said active agent is more than one active agent.  
   
   
       35 . The method according to claims  1  or  2  or  3  wherein said mousse composition further comprises at least one member selected from the group consisting of a preservative, a stabilizer, an antioxidant, a pH adjusting agent, a skin penetration enhancer, and a viscosity modifying agent.