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Claims for Patent: 7,179,475

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Claims for Patent: 7,179,475

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 Consumer Companies, Inc. (Skillman, NJ)
Application Number:09/562,376
Patent Claims: 1. An anhydrous composition formulated for topical delivery consisting of: (a) propylene glycol, (b) polyethylene glycol, (c) glycerin, (d) about 1.0 to about 50 percent by weight of ethanol, (e) ketoconazole, (f) PPG-15 stearyl ether, (g) hydroxypropyl cellulose, (h) ascorbic acid, (i) butylated hydroxytoluene, and (j) citric acid, wherein the composition is formulated as a gel.

2. An anhydrous composition formulated for topical delivery consisting of: (a) propylene glycol, (b) polyethylene glycol, (c) glycerin, (d) about 1.0 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) at least one member selected from the group consisting of a colorant, fragrance, UV stabilizer and sunscreen, wherein the composition is formulated as a gel.

3. The anhydrous composition of claim 2 consisting of: (a) propylene glycol, (b) polyethylene glycol, (c) glycerin, (d) about 1.0 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) at least one colorant, wherein the composition is formulated as a gel.

4. The composition of any one of claims 1, 2 and 3 wherein the ketoconazole is solubilized.

5. The composition of any one of claims 1, 2 and 3 wherein the amount of the ketoconazole is about 0.5 to about 3 percent by weight.

6. The composition of any one of claims 1, 2 and 3 wherein the amount of the ketoconazole is about 2.0 percent by weight.

7. The composition of any one of claims 1, 2 and 3 wherein the amount of the polyethylene glycol is about 10 to about 80 percent by weight.

8. The composition of claim 7 wherein the amount of the polyethylene glycol is about 20 percent by weight.

9. The composition of any one of claims 1, 2 and 3 wherein the amount of the propylene glycol is about 1.0 to about 50 percent by weight.

10. The composition of claim 9 wherein the amount of the propylene glycol is about 20 percent by weight.

11. The composition of any one of claims 1, 2 and 3 wherein the amount of the glycerin is about 10 to about 80 percent by weight.

12. The composition of claim 11 wherein the amount of the glycerin is about 20 percent by weight.

13. The composition of any one of claims 1, 2 and 3 wherein the amount of the PPG-15 stearyl ether is between 0 and about 2 percent by weight.

14. The composition of claim 13 wherein the amount of the 15 stearyl ether is about 2 percent by weight.

15. The composition of any one of claims 1, 2 and 3 wherein the amount of the hydroxypropyl cellulose is about 1.5 to about 2.0 percent by weight.

16. The composition of any one of claims 1, 2 and 3 wherein the amount of the ascorbic acid is between 0 and about 0.3 percent by weight.

17. The composition of claim 16 wherein the amount of the ascorbic acid is about 0.3 percent by weight.

18. The composition of any one of claims 1, 2 and 3 wherein the amount of the citric acid is between 0 and about 0.5 percent by weight.

19. The composition of claim 18 wherein the amount of the citric acid is about 0.1 percent by weight.

20. The composition of any one of claims 1, 2 and 3 wherein the amount of the butylated hydroxytoluene is between 0 and about 0.1 percent by weight.

21. A method of delivering a composition of any one of claims 1, 2 and 3 for the treatment of skin fungal disorders to a recipient in need of such treatment comprising topically administering the composition to the recipient.

22. The method of claim 21 wherein the recipient is a human.

23. The method of claim 22 wherein the human is suffering from seborrheic dermatitis.

24. A method of treating skin fungal disorders comprising topically administering the composition of any one of claims 1, 2 and 3 to a recipient in need of such treatment.

25. The method of claim 24 wherein the recipient is a human.

26. The method of claim 25 wherein the skin fungal disorders are associated with T. rubrum or P. ovale.

27. The method of claim 25, wherein the skin fungal disorders are selected from the group consisting of tinea corporis, tinea cruria, tinea pedis and seborrheic dermatitis.

28. A method of treating seborrheic dermatitis comprising topically administering the composition of any one of claims 1, 2 and 3 to a recipient in need of such treatment.

29. The method of claim 28 wherein the recipient is a human.

30. The method of claim 21 wherein the skin fungal disorders are associated with T. rubrum or P. ovale.
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