Polymer-based sustained release device

Abstract

This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

1 . A process for preparing microparticles, comprising:
 forming a water-in-oil emulsion from an aqueous phase and an oil phase, wherein the aqueous phase comprises a water soluble polypeptide and a sugar and the oil phase comprises a poly(lactide-co-glycolide) polymer and a polymer solvent for the poly(lactide-co-glycolide) polymer;   adding silicone oil to the water-in-oil emulsion to thereby form embryonic microparticles, wherein the silicone oil is added in an amount sufficient to achieve a silicone oil to polymer solvent ratio of from about 1:1 to about 1.5:1;   hardening the embryonic microparticles to form hardened microparticles; and   drying the hardened microparticles to form finished microparticles, wherein the finished microparticles include from about 3% to about 5% w/w of the polypeptide.