Patent ID: 6455526
Filing Date: 2002-09-24
Classification: A61K

Abstract:
A method for the production of a pharmaceutical composition comprising the steps of:a) mixing a suitable amount of pharmaceutically active compound of Formula I: â€ƒor a pharmaceutically acceptable salt thereof with a suitable amount of biodegradable polymer for a sufficient period of time and at suitable temperature and pressure conditions to form a dry mixture of said pharmaceutically active compound and said polymer, wherein said biodegradable polymer has a glass transition temperature (Tg) of less than about 60Â° C.; b) subjecting said dry mixture to a suitable shear mixing using a single screw extruder under suitable temperature and pressure conditions for a sufficient period of time such that said polymer softens to form a fluidized medium and said pharmaceutically active compound is sufficiently dissolved to form a solid solution having substantially homogeneously dispersed mixture of said pharmaceutically active compound and said polymer, and said homogeneous mixture is formed into a strand; c) pelletizing said strand; and d) pulverizing said pellets to form sustained release microparticles of said biodegradable polymer and said pharmaceutically active compound, wherein said microparticles are having a size distribution in the range of from about 10 to 200 &mgr;m such that said microparticles are suitable for forming an injectable formulation.