EP4719350A1 — Stable cyclosporine ophthalmic formulation and manufacturing process thereof

USPTO Abstract

The present invention relates to a stable nanomicellar ophthalmic formulation comprising cyclosporine, hydrogenated 40 polyoxyl castor oil, octoxynol-40, and an aqueous vehicle, wherein the stable nanomicellar ophthalmic formulation is made by a method comprising: a) mixing the hydrogenated 40 polyoxyl castor oil and the octoxynol-40, wherein the mixing produces a Mixture A comprising a water content of less than 3%; b) adding the cyclosporine to the Mixture A to form a Mixture B; and c) mixing the Mixture B with the aqueous vehicle, thereby forming the stable nanomicellar ophthalmic formulation.