Patent ID: 8313774
Filing Date: 2012-11-20
Classification: A61K

Abstract:
1. An oral extended-release tablet composition for treating depression comprising: (1) a particle comprising an amorphous structure and a submicron domain, wherein the amorphous structure comprises duloxetine hydrochloride and an amphiphilic polymer, and wherein the submicron domain consists essentially of duloxetine hydrochloride, (2) a micronized duloxetine hydrochloride particle, and (3) a pharmaceutically excipient; wherein the particle comprising an amorphous structure and a submicron domain is prepared by dissolving duloxetine hydrochloride and polyvinylpyrrolidone in a co-solvent, adding a non-solvent to precipitate a portion of duloxetine hydrochloride, drying and then milling of the resulting mass, and wherein the ratio of the amorphous structure to the submicron domain is 0.1:5 to 1:1.