Claims for Patent: 6,730,288

Summary for Patent: 6,730,288

Title:	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.
Inventor(s):	Abram; Albert Zorko (Wantirna, AU)
Assignee:	Connetics Australia Pty Ltd (Rowville, AU)
Application Number:	09/719,662
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,730,288
Patent Claims:	1. A pharmaceutical aerosol foam composition comprising: an effective amount of a pharmaceutically active ingredient; an occlusive agent; an aqueous solvent; an organic cosolvent; and an emulsifier component in an amount wherein the ratio of emulsifier component to a combination of the occlusive agent, pharmaceutically active ingredient, and organic cosolvent is about 1:5 to about 1:8; 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. 2. The pharmaceutical aerosol foam composition according to claim 1, wherein the occlusive agent is petrolatum. 3. The pharmaceutical aerosol foam composition according to claim 1, 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. 4. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, 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 pharmaceutical aerosol foam composition. 5. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, 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. 6. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, wherein the aqueous solvent is present in an amount of from approximately 25 to 95% by weight, based on the total weight of the composition. 7. The pharmaceutical aerosol composition according to claim 1 or claim 2, wherein the organic cosolvent is present in an amount from approximately 0.25% by weight to 50% by weight, based on the total weight of the composition. 8. The pharmaceutical aerosol foam composition according to claim 7 wherein the organic cosolvent is an alkyl benzoate. 9. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, further including an effective amount of an aerosol propellant. 10. The pharmaceutical aerosol foam composition according to claim 9, wherein the aerosol propellant is a hydrocarbon and is present in an amount of from approximately 2.5 to 20% by weight, based on the total weight of the composition. 11. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, wherein the occlusive agent is present in an amount of approximately 55% by weight or less, based on the total weight of the composition. 12. The pharmaceutical aerosol foam composition according to claim 11, wherein the occlusive agent is present in an amount of approximately 10 to 50% by weight, based on the total weight of the composition. 13. The pharmaceutical aerosol foam composition according to claim 1 or claim 2, wherein the emulsifier component is selected from the group consisting of a non-ionic, cationic or anionic surfactant, a fatty alcohol, a fatty acid and fatty acid salts thereof. 14. The pharmaceutical aerosol foam composition according to claim 13, wherein the emulsifier component includes a mixture of a sorbitan ester and a polyoxyethylene fatty alcohol ether. 15. The pharmaceutical foam composition according to claim 1 or claim 2, wherein the water insoluble pharmaceutically active ingredient is selected from the group consisting of an analgesic, anti-inflammatory agent, antifungal, antibacterial, anesthetic, xanthine, sex hormone, antiviral, antipruritic, antihistamine and corticosteroid. 16. The pharmaceutical aerosol foam composition according to claim 15, wherein the pharmaceutically active ingredient is a corticosteroid selected from the group consisting of betamethasone valerate and clobetasol propionate. 17. The pharmaceutical aerosol foam composition according to claim 15, wherein the pharmaceutically active ingredient is a corticosteroid selected from one or more of the group consisting of betamethasone valerate and clobetasol propionate. 18. A pharmaceutical aerosol dispenser comprising: a pharmaceutical aerosol foam composition including an effective amount of a pharmaceutically active ingredient; an occlusive agent; an aqueous solvent; an organic cosolvent; and an emulsifier component in an amount wherein the ratio of emulsifier component to a combination of the occlusive agent, pharmaceutically active ingredient, and organic cosolvent is about 1:5 to about 1:8; 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. 19. A pharmaceutical aerosol foam composition consisting essentially of: an effective amount of a pharmaceutically active ingredient; an occlusive agent; an aqueous solvent; an organic cosolvent; and 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. 20. The pharmaceutical aerosol foam composition according to claim 19, wherein the occlusive agent is petrolatum. 21. The pharmaceutical aerosol foam composition according to claim 19, 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. 22. The pharmaceutical foam composition according to claim 19 or claim 20, wherein the water insoluble pharmaceutically active ingredient is selected from the group consisting of an analgesic, an anti-inflammatory agent, an antifungal, an antibacterial, an anesthetic, a xanthine, a sex hormone, an antiviral, an antipruritic, an antihistamine and a corticosteroid. 23. The pharmaceutical aerosol foam composition according to claim 19 or claim 20, wherein the pharmaceutically active ingredient is present in amounts of from approximately 0.005% by weight to approximately 10% by weight, based on the total weight of the pharmaceutical aerosol foam composition. 24. The pharmaceutical aerosol foam composition according to claim 19 or claim 20, wherein the occlusive agent is present in an amount of approximately 55% by weight or less, based on the total weight of the composition. 25. The pharmaceutical aerosol foam composition according to claim 24, wherein the occlusive agent is present in an amount of approximately 10 to 50% by weight, based on the total weight of the composition. 26. The pharmaceutical aerosol foam composition according to claim 19 or claim 20, wherein the aqueous solvent is present in an amount of from approximately 25 to 95% by weight, based on the total weight of the composition. 27. The pharmaceutical aerosol composition according to claim 19 or claim 20, wherein the organic cosolvent is present in an amount from approximately 0.25% by weight to 50% by weight, based on the total weight of the composition. 28. The pharmaceutical aerosol foam composition according to claim 27 wherein the organic cosolvent is an alkyl benzoate. 29. The pharmaceutical aerosol foam composition according to claim 19 or 20, further including an effective amount of an aerosol propellant. 30. The pharmaceutical aerosol foam composition according to claim 29, wherein the aerosol propellant is a hydrocarbon and is present in an amount of from approximately 2.5 to 20% by weight, based on the total weight of the composition. 31. The pharmaceutical aerosol foam composition according to claim 19 or claim 20, further including an effective amount of an emulsifier component. 32. The pharmaceutical aerosol foam composition according to claim 31, 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. 33. The pharmaceutical aerosol foam composition according to claim 31, wherein the emulsifier component is selected from the group consisting of a non-ionic, cationic or anionic surfactant, a fatty alcohol, a fatty acids and fatty acid salts thereof. 34. The pharmaceutical aerosol foam composition according to claim 33, wherein the emulsifier component includes a mixture of a sorbitan ester and a polyoxyethylene fatty alcohol ether. 35. A pharmaceutical aerosol dispenser comprising a pharmaceutical aerosol foam composition, said composition consisting essentially of: an effective amount of a pharmaceutically active ingredient an occlusive agent; an aqueous solvent; an organic cosolvent; and 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. 36. The pharmaceutical aerosol dispenser of claim 35, wherein said foam composition further includes an effective amount of an emulsifier component. 37. A pharmaceutical aerosol foam composition comprising: an effective amount of a corticosteroid; an occlusive agent; an aqueous solvent; an organic cosolvent; and 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. 38. The pharmaceutical aerosol foam composition according to claim 37, further comprising an emulsifier component in an amount of from approximately 1 to 15% by weight, based on the total weight of the composition. 39. A pharmaceutical aerosol foam composition comprising: an occlusive agent in an amount up to 50% by weight, based on the total weight of the composition; an aqueous solvent; an organic cosolvent, an effective amount of clobetasol propionate, wherein said clobetasol propionate is solubilized in the composition. 40. A pharmaceutical aerosol foam composition comprising: petrolatum in an amount of approximately 10 to 50% by weight, based on the total weight of the composition; an aqueous solvent; an organic cosolvent, an effective amount of clobetasol propionate, wherein said clobetasol propionate is solubilized in the composition.