Patent ID: 8877252

Claim:
A method of preparing a composition for the sustained release of a glucoregulatory peptide comprising the steps of: a) forming a mixture by combining: an aqueous phase comprising a sugar and a water-soluble glucoregulatory peptide, with an oil phase comprising a biocompatible polymer and a solvent for the biocompatible polymer; b) forming a water-in-oil emulsion of the mixture from step a), wherein the inner emulsion droplet size is less than about 0.5 microns; c) adding a coacervation agent to the mixture to form embryonic microparticles, wherein the coacervation agent is silicone oil added in an amount sufficient to achieve a silicone oil to polymer solvent ratio of from about 0.75:1 to about 2:1; d) transferring the embryonic microparticles to a quench solvent to harden the microparticles; e) collecting the hardened microparticles; and f) drying the hardened microparticles, wherein the glucoregulatory peptide is present in the composition at a concentration of about 0.01% to about 10% w/w based on the total weight of the composition, and the sugar is present in the composition at a concentration of about 0.01% to about 5% w/w based on the total weight of the composition.