Details for Patent: 8,232,276

Title:	Anhydrous topical skin preparations
Abstract:	The present invention provides anhydrous compositions for topical delivery of a medicament comprising (A) a penetration enhancer/solvent selected from the group consisting of alcohol, propylene glycol, or a combination thereof; (B) a humectant/solvent selected from the group consisting of polyethylene glycol, glycerin, sorbitol, xylitol, or any combination of any of the foregoing; and (C) an anhydrous vehicle. In an alternate embodiment, the present invention provides anhydrous compositions for topical delivery of a medicament which comprise (A) a penetration enhancer/solvent selected from the group consisting of alcohol, propylene glycol, or a combination thereof; (B) a humectant/solvent selected from the group consisting of polyethylene glycol, glycerin, sorbitol, xylitol or any combination of any of the foregoing; (C) an anhydrous vehicle; and (D) a medicament. Also provided are methods for topically delivering a medicament to an animal, such as a mammal or a human patient, in need of the medicament by topically administering to the animal the compositions of the present invention.
Inventor(s):	Burnett; Katherine M. (Basking Ridge, NJ), Kurtz; Ellen S. (Ringoes, NJ)
Assignee:	Johnson & Johnson Comsumer Companies, Inc. (Skillman, NJ)
Filing Date:	Nov 26, 2003
Application Number:	10/722,134
Claims:	1. An anhydrous composition formulated for topical delivery consisting of: (a) an anhydrous vehicle consisting of about 1 to about 50 percent by weight of ethanol, (b) a penetration enhancer consisting of about 1 to about 50 percent by weight of propylene glycol, (c) a humectant consisting of about 10 to about 80 percent by weight of polyethylene glycol and glycerin, (d) ketoconazole in an amount of about 0.5 to about 3 percent by weight, and (e) a gelling agent, and (f) on or more components selected from the group consisting of emollients, chelating agents, pH adjusters, antioxidants, viscosifiers, colorants, fragrances, UV stabilizers, and sunscreens, and, wherein the composition is formulated as an anhydrous gel. 2. The composition of claim 1 wherein the ketoconazole is solubilized. 3. The composition of claim 1 wherein the amount of the ketoconazole is about 2.0 percent by weight. 4. The composition of claim 1 wherein the amount of the polyethylene glycol is about 20 percent by weight. 5. The composition of claim 1 wherein the amount of the propylene glycol is about 20 percent by weight. 6. The composition of claim 1 wherein the amount of the glycerin is about 20 percent by weight. 7. An anhydrous composition formulated for topical delivery consisting of: (a) propylene glycol, (b) polyethylene glycol, (c) glycerin, (d) about 1 to about 50 percent by weight of ethanol, (e) ketoconazole, (f) PPG-15 stearyl ether, (g) hydroxypropyl cellulose, (h) ascorbic acid, (i) butylated hydroxytoluene, (j) citric acid, and (k) a colorant, wherein the composition is formulated as an anhydrous gel. 8. A method of delivering a composition of claim 1 or claim 7 for the treatment of skin fungal disorders to a recipient in need of such treatment comprising topically administering the composition to the recipient. 9. The method of claim 8 wherein the recipient is a human. 10. The method of claim 9 wherein the human is suffering from seborrheic dermatitis. 11. A method of treating skin fungal disorders comprising topically administering the composition of claim 1 or claim 7 to a recipient in need of such treatment. 12. The method of claim 11 wherein the recipient is a human. 13. The method of claim 12 wherein the skin fungal disorders are associated with T. rubrum or P. ovale. 14. The method of claim 13, wherein the skin fungal disorders are selected from the group consisting of tinea corporis, tinea cruria, tinea pedis and seborrheic dermatitis. 15. A method of treating seborrheic dermatitis comprising topically administering the composition of claim 1 or claim 7 to a recipient in need of such treatment. 16. The method of claim 15 wherein the recipient is a human. 17. The method of claim 8 wherein the skin fungal disorders are associated with T. rubrum or P. ovale. 18. The composition of claim 1 wherein the one or more components is at least an emollient. 19. The composition of claim 18 wherein the emollient is PPG-15 stearyl ether. 20. The composition of claim 19 wherein the amount of the PPG-15 stearyl ether is about 2 percent by weight. 21. The composition of claim 1 wherein the one or more components is at least a viscosifier. 22. The composition of claim 21 wherein the viscosifier is hydroxypropyl cellulose. 23. The composition of claim 22 wherein the amount of hydroxypropyl cellulose is about 1.5 to about 2.0 percent by weight. 24. The composition of claim 1 wherein the one or more components is at least a pH adjuster. 25. The composition of claim 24 wherein the pH adjuster is selected from the group consisting of ascorbic acid, citric acid and combinations thereof. 26. The composition of claim 25 wherein the amount of the ascorbic acid. 27. The composition of claim 25 wherein the amount of the citric acid. 28. The composition of claim 26 wherein the amount of the ascorbic acid is about 0.3 percent by weight. 29. The composition of claim 27 wherein the amount of the citric acid is about 0.1 percent by weight. 30. The composition of claim 1 wherein the one or more components is at least an antioxidant. 31. The composition of claim 30 wherein the antioxidant is selected from the group consisting of ascorbic acid, butylated hydroxytoluene and combinations thereof. 32. The composition of claim 31 wherein the amount of the butylated hydroxytoluene. 33. The composition of claim 32 wherein the amount of the butylated hydroxytoluene is about 0.1 percent by weight.