Patent ID: 8110224

Claim:
A process for producing microparticles comprising the steps of: a) dissolving at least one polypeptide in an aqueous buffer to produce an active ingredient solution, b) dissolving a biologically degradable polymer, a water-soluble polymer, and lecithin in an organic solvent to produce a polymer solution containing about 20% lecithin, c) mixing a water-soluble polymer with an aqueous buffer to form an aqueous solution, d) mixing the active ingredient solution of a) and the polymer solution of b) using a gear pump to form an emulsion, e) pumping the emulsion of d) and the aqueous solution of c) with a gear pump to a static mixer and mixing the same in the static mixer to form a water in oil in water emulsion, f) removing the solvent from the emulsion of e), and g) separating the microparticles by filtering and freeze-drying, wherein the microparticles do not exhibit an initial burst release of the therapeutic polypeptide contained therein.