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Claims for Patent: 8,486,978

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Claims for Patent: 8,486,978

Title:Compositions and methods for treating diseases of the nail
Abstract: Methods and compositions for treating disorders of the nail and nail bed. Such compositions contain a vehicle in which all components of the composition are dissolved, suspended, dispersed, or emulsified, a non-volatile solvent, a wetting agent, and a pharmaceutically active ingredient that is soluble in the non-volatile solvent and/or a mixture of the vehicle and the non-volatile solvent, which composition has a surface tension of 40 dynes/cm or less and has continuing spreadability, and which composition is effective in treating a disorder of the nail or nail bed.
Inventor(s): Winckle; Gareth (Petaluma, CA), Fieldson; Gregory T. (Morgantown, WV)
Assignee: Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:13/199,717
Patent Claims: 1. A pharmaceutical composition consisting essentially of a vehicle that is volatile and/or that rapidly penetrates a nail following application onto the surface of the nail, a triazole antifungal active pharmaceutical ingredient (API), and a wetting agent, and optionally a non-volatile solvent that is dissolved, suspended, dispersed, or emulsified within the vehicle, wherein the surface tension of the composition is 40 dynes/cm or less and wherein the composition, when applied to the surface of a nail, does not form a solid film.

2. The pharmaceutical composition for the topical treatment of a disorder of the nail or nail bed of claim 1 wherein the vehicle is alcohol and the wetting agent is a volatile silicone, and wherein the composition contains a non-volatile solvent that is dissolved, suspended, dispersed, or emulsified within the vehicle wherein the non-volatile solvent is one or more esters of the formula RCO--OR', wherein R and R' may be identical or different and each of R and R' represents a linear or branched chain of an alkyl, alkenyl, alkoxycarbonylalkyl, or alkoxycarbonyloxyalkyl radical having from 1 to 25 carbon atoms, and wherein the chain of R' is at least 5 carbons, wherein the volatile silicone is present in the composition at a concentration less than 25% w/w.

3. The pharmaceutical composition of claim 2 wherein the ester is a combination of diisopropyl adipate and C12-15 alkyl lactate.

4. The pharmaceutical composition of claim 2 wherein the ester is a combination of diisopropyl adipate and myristyl lactate.

5. The pharmaceutical composition of claim 2 wherein the triazole antifungal agent is (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4- -triazole-1-yl)butane-2-ol.

6. The pharmaceutical composition of claim 2 wherein the alcohol is ethanol.

7. The pharmaceutical composition of claim 2 wherein the volatile silicone is a cyclic silicone.

8. The pharmaceutical composition of claim 7 wherein the cyclic silicone is a cyclomethicone.

9. The pharmaceutical composition of claim 2 wherein the concentration of volatile silicone is less than 20%.

10. The pharmaceutical composition of claim 2 wherein the concentration of volatile silicone is less than 15%.

11. The pharmaceutical composition of claim 1 that consists essentially of alcohol, cyclomethicone, diisopropyl adipate, either or both of C12-15 alkyl lactate and isopropyl myristate, and a triazole antifungal agent.

12. The pharmaceutical composition of claim 11 that consists essentially of the following components in the following ranges of concentrations % w/w: a. alcohol--10% to 80% b. cyclomethicone--0.01% to less than 25% c. diisopropyl adipate plus either or both of C12-15 alkyl lactate and isopropyl myristate--5% to 90% d. triazole antifungal agent--0.0001% to 30%.

13. The pharmaceutical composition of claim 12 that consists essentially of: a. alcohol--50% to 70%, b. cyclomethicone--10% to 15% c. diisopropyl adipate--8% to 15% d. either or both of C12-15 alkyl lactate and isopropyl myristate--8% to 15% e. triazole antifungal agent--2% to 15%.

14. The pharmaceutical composition of claim 13 wherein the triazole antifungal agent is (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4- -triazole-1-yl)butane-2-ol.

15. The pharmaceutical composition of claim 2 wherein the composition does not include a polymeric film forming compound.

16. The pharmaceutical composition of claim 2 which increases in spread on the surface of a clean dry glass slide throughout the six-minute period immediately following application of the composition to the surface of the slide.

17. The pharmaceutical composition of claim 16 wherein the spread of the composition on the surface of the slide encompasses an area of greater than 11.0 cm within 10 minutes following application of 100 microliters of the composition to the surface of the slide.

18. The pharmaceutical composition of claim 2 wherein the surface tension of the composition is 35 dynes/cm or less.

19. The pharmaceutical composition of claim 18 wherein the surface tension of the composition is 30 dynes/cm or less.

20. The pharmaceutical composition of claim 18 wherein the surface tension of the composition is 25 dynes/cm or less.

21. The pharmaceutical composition for the topical treatment of a disorder of the nail or nail bed of claim 1 which consists essentially of a volatile alcohol, a volatile silicone, one or more esters of the formula RCO--OR', wherein R and R' may be identical or different and each of R and R' represents a linear or branched chain of an alkyl, alkenyl, alkoxycarbonylalkyl, or alkoxycarbonyloxyalkyl radical having from 1 to 25 carbon atoms, and wherein the chain of R' is at least 5 carbons, and a triazole antifungal agent, wherein the ratio of alcohol to volatile silicone in the composition % w/w is at least 2:3.

22. The pharmaceutical composition of claim 21 wherein the ester is combination of diisopropyl adipate and C12-15 alkyl lactate.

23. The pharmaceutical composition of claim 21 wherein the ester is a combination of diisopropyl adipate and myristyl lactate.

24. The pharmaceutical composition of claim 21 wherein the triazole antifungal agent is (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4- -triazole-1-yl)butane-2-ol.

25. The pharmaceutical composition of claim 21 wherein the alcohol is ethanol.

26. The pharmaceutical composition of claim 21 wherein the volatile silicone is a cyclic silicone.

27. The pharmaceutical composition of claim 21 wherein the cyclic silicone is a cyclomethicone.

28. The pharmaceutical composition of claim 21 wherein the ratio of alcohol to volatile silicone is at least 1:1.

29. The pharmaceutical composition of claim 21 wherein the ratio of alcohol to volatile silicone is at least 2:1.

30. The pharmaceutical composition of claim 21 wherein the ratio of alcohol to volatile silicone is at least 3:1.

31. The pharmaceutical composition of claim 21 wherein the composition does not include a polymeric film forming compound.

32. The pharmaceutical composition of claim 21 which increases in spread on the surface of a clean dry glass slide throughout the six-minute period immediately following application of the composition to the surface of the slide.

33. The pharmaceutical composition of claim 21 wherein the spread of the composition on the surface of the slide encompasses an area of greater than 11.0 cm within 10 minutes following application of 100 microliters of the composition to the surface of the slide.

34. The pharmaceutical composition of claim 21 that consists essentially of alcohol, cyclomethicone, diisopropyl adipate, either or both of C12-15 alkyl lactate and isopropyl myristate, and a triazole antifungal agent.

35. The pharmaceutical composition of claim 34 that consist essentially of the following components in the following ranges of concentrations % w/w: a. alcohol--10% to 80% b. cyclomethicone--0.01% to less than 25% c. diisopropyl adipate plus either or both of C12-15 alkyl lactate and is isopropyl myristate--5% to 90% d. triazole antifungal agent--0.0001% to 30%.

36. The pharmaceutical composition of claim 35 that consists essentially of: a. alcohol--50% to 70%, b. cyclomethicone--10% to 15% c. diisopropyl adipate--8% to 15% d. either or both of C12-15 alkyl lactate and isopropyl myristate--8% to 15% e. triazole antifungal agent--2% to 15%.

37. The pharmaceutical composition of claim 36 wherein the triazole antifungal agent is (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4- -triazole-1-yl)butane-2-ol.

38. The pharmaceutical composition of claim 21 wherein the surface tension of the composition is 35 dynes/cm or less.

39. The pharmaceutical composition of claim 38 wherein the surface tension of the composition is 30 dynes/cm or less.

40. The pharmaceutical composition of claim 39 wherein the surface tension of the composition is 25 dynes/cm or less.

41. A pharmaceutical composition consisting essentially of a vehicle that is volatile and/or that rapidly penetrates a nail following application onto the surface of the nail, an antifungal active ingredient (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4- -triazole-1-yl)butane-2-ol, and a wetting agent, and optionally a non-volatile solvent that is dissolved, suspended, dispersed, or emulsified within the vehicle, wherein the surface tension of the composition is 40 dynes/cm or less and wherein the composition, when applied to the surface of a nail, does not form a solid film.

42. The pharmaceutical composition of claim 41 that does not include a polymeric film forming compound.
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