Claims for Patent: 9,937,225

Summary for Patent: 9,937,225

Title:	Topical formulations and uses thereof
Abstract:	Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.
Inventor(s):	Mitra; Ashim K. (Overland Park, KS), Weiss; Sidney L. (Randolph, NJ)
Assignee:	SUN PHARMA GLOBAL FZE (Sharjah, AE)
Application Number:	15/153,510
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,937,225
Patent Claims:	1. An aqueous clear nanomicellar ophthalmic formulation comprising 0.05-0.5% by weight cyclosporine, a polyalkoxylated alcohol and one or more polymers comprising HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 35 castor oil or combinations thereof. 2. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer comprises HCO-40, HCO-60, HCO-80, HCO-100 or combinations thereof. 3. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer comprises polyoxyl 35 castor oil. 4. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer is HCO-40. 5. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer is 0.5-1.5% by weight of the formulation. 6. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer comprises HCO-40 HCO-60, HCO-80, or combinations thereof and is 0.5-1.5% by weight of the formulation. 7. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polyalkoxylated alcohol comprises Octoxynol-40. 8. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein the polyalkoxylated alcohol comprises Octoxynol-40 and is 0.02-4% by weight of the formulation. 9. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein the polyalkoxylated alcohol comprises Octoxynol-40 and is 0.02-0.1% by weight of the formulation. 10. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein the cyclosporine is 0.05-0.2% by weight of the formulation. 11. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer comprises HCO-40, HCO-60, HCO-80, HCO-100 or combinations thereof; and wherein said polyalkoxylated alcohol is Octoxynol-40. 12. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer is 0.5-1.5% by weight of the formulation; and said polyalkoxylated alcohol is Octoxynol-40 and is 0.02-0.1% of the formulation. 13. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer is 0.5-1.5% of the formulation; said polyalkoxylated alcohol comprises Octoxynol-40 and is 0.02-0.1% of the formulation; and the cyclosporine is 0.05-0.2% of the formulation. 14. A method of treating or preventing an ocular disease or condition, said method comprising topically administering an aqueous clear nanomicellar formulation of claim 1. 15. A method of treating or preventing an ocular disease or condition, said method comprising topically administering an aqueous clear nanomicellar formulation of claim 13. 16. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said formulation provides higher average concentration of cyclosporine in cornea, conjunctiva and sclera in comparison to higher marketed strength. 17. The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said formulation demonstrates mean cumulative inflammatory score of less than 2.