Claims for Patent: 10,342,875

Summary for Patent: 10,342,875

Title:	Stabilized efinaconazole compositions
Abstract:	The present invention provides compositions containing efinaconazole, butylated hydroxytoluene, a salt of ethylenediaminetetraacetic acid, and optional citric acid. The compositions exhibit stable color profiles and are useful in the treatment of fungal infections.
Inventor(s):	Bhatt; Varsha (San Francisco, CA), Desai; Nayan (Santa Rosa, CA), Pillai; Radhakrishnan (Santa Rosa, CA)
Assignee:	Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:	15/607,594
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,342,875
Patent Claims:	1. A composition comprising about 10% efinaconazole by weight, water, C12-15 alkyl lactate, diisopropyl adipate, cyclomethicone, ethanol, butylated hydroxytoluene (BHT), a salt of ethylenediaminetetraacetic acid (EDTA), and citric acid, wherein: the amount of BHT ranges from about 0.01% (w/w) to about 2% (w/w), the amount of the salt of EDTA ranges from about 0.0001% (w/w) to about 1.5% (w/w), the amount of citric acid ranges from about 0.05% (w/w) to about 0.25% (w/w), and the composition is formulated as a solution. 2. The composition of claim 1, wherein the amount of the salt of EDTA ranges from about 0.0001% (w/w) to about 0.0005% (w/w). 3. The composition of claim 2, wherein the amount of the salt of EDTA is about 0.00025% (w/w) and the amount of BHT is about 0.1% (w/w). 4. The composition of claim 1, wherein the amount of citric acid ranges from about 0.075% (w/w) to about 0.15% (w/w). 5. The composition of claim 1, wherein: the amount of ethanol ranges from about 50% to about 70% (w/w), the amount of cyclomethicone ranges from about 10% to about 15% (w/w), the amount of diisopropyl adipate ranges from about 8% to about 15% (w/w), and the amount of C12-15 alkyl lactate ranges from about 8% to about 15% (w/w). 6. The composition of claim 5, wherein the amount of the salt of EDTA ranges from about 0.0001% (w/w) to about 0.0005% (w/w). 7. The composition of claim 6, wherein the amount of the salt of EDTA is about 0.00025% (w/w) and the amount of BHT is about 0.1% (w/w). 8. The composition of claim 5, wherein the amount of citric acid ranges from about 0.075% (w/w) to about 0.15% (w/w). 9. The composition of claim 1, wherein: the amount of the salt of EDTA is about 0.00025% (w/w), the amount of BHT is about 0.1% (w/w), the amount of citric acid ranges from about 0.075% (w/w) to about 0.15% (w/w), the amount of ethanol ranges from about 50% to about 70% (w/w), the amount of cyclomethicone ranges from about 10% to about 15% (w/w), the amount of diisopropyl adipate ranges from about 8% to about 15% (w/w), and the amount of C12-15 alkyl lactate ranges from about 8% to about 15% (w/w). 10. A method of treating a fungal infection comprising administering a therapeutically effective amount of a formulation according to claim 1 to a patient in need of such treatment. 11. A method of treating a fungal infection comprising administering a therapeutically effective amount of a formulation according to claim 9 to a patient in need of such treatment. 12. The method of claim 11, wherein the fungal infection is onychomycosis. 13. The method of claim 12, wherein the administering comprises applying the formulation to a nail of the subject at least three times a week for a period ranging from about one week to about 12 weeks. 14. The method of claim 13, wherein the formulation is applied once daily. 15. The method of claim 13, wherein the formulation is applied twice daily.