Claims for Patent: 10,828,369

Summary for Patent: 10,828,369

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):	Gareth Winckle, Gregory T. Fieldson
Assignee:	Bausch Health Ireland Ltd
Application Number:	US16/128,835
Patent Claims:	1. A pharmaceutical composition for the topical treatment of a disorder of the nail or nail bed comprising: (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol in a concentration ranging from 0.0001% (w/w) to 30% (w/w), ethanol in a concentration ranging from 10% (w/w) to 80% (w/w), cyclomethicone in a concentration ranging from 1% (w/w) to 40% (w/w), diisopropyl adipate plus C12-15 alkyl lactate in a combined concentration ranging from 10% (w/w) to 80% (w/w), wherein the composition is formulated as a solution; wherein the surface tension of the composition is 40 dynes/cm or less; and wherein the composition does not comprise a polymeric film forming compound. 2. The pharmaceutical composition of claim 1, wherein the surface tension of the composition is 30 dynes/cm or less. 3. The pharmaceutical composition of claim 1, wherein the surface tension of the composition is 25 dynes/cm or less. 4. The pharmaceutical composition of claim 1, wherein the concentration of (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol ranges from 2% (w/w) to 15% (w/w). 5. The pharmaceutical composition of claim 1, wherein the concentration of (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol is 10% (w/w). 6. The pharmaceutical composition of claim 1 comprising diisopropyl adipate in a concentration ranging from 8% (w/w) to 15% (w/w), C12-15 alkyl lactate in a concentration ranging from 8% (w/w) to 15% (w/w), and ethanol in a concentration of at least 40% (w/w). 7. The pharmaceutical composition of claim 1 comprising cyclomethicone in a concentration ranging from 2% (w/w) to 15% (w/w). 8. The pharmaceutical composition of claim 7 comprising diisopropyl adipate in a concentration ranging from 8% (w/w) to 15% (w/w), C12-15 alkyl lactate in a concentration ranging from 8% (w/w) to 15% (w/w), and ethanol in a concentration of at least 40% (w/w). 9. The pharmaceutical composition of claim 8, wherein the concentration of (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol is 10% (w/w). 10. The pharmaceutical composition of claim 1, further comprising an antioxidant in a concentration ranging from 0.001% (w/w) to 0.5% (w/w). 11. The pharmaceutical composition of claim 10 comprising diisopropyl adipate in a concentration ranging from 8% (w/w) to 15% (w/w), C12-15 alkyl lactate in a concentration ranging from 8% (w/w) to 15% (w/w), and ethanol in a concentration of at least 40% (w/w). 12. The pharmaceutical composition of claim 11, wherein the concentration of (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol is 10% (w/w). 13. The pharmaceutical composition of claim 1 comprising ethanol in a concentration of at least 15% (w/w). 14. The pharmaceutical composition of claim 1 comprising ethanol in a concentration of at least 25% (w/w). 15. The pharmaceutical composition of claim 14 comprising diisopropyl adipate in a concentration ranging from 8% (w/w) to 15% (w/w), C12-15 alkyl lactate in a concentration ranging from 8% (w/w) to 15% (w/w), and ethanol in a concentration of at least 40% (w/w). 16. The pharmaceutical composition of claim 15, wherein the concentration of (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-ol is 10% (w/w).