Preparation of peptide loaded plga microspheres with controlled release characteristics

A process for the preparation of a poly(D,L lactide-co-glycolide) polymer microspheres of a peptide, which peptide can also be in the form of a pharmaceutically-acceptable salt, comprising:

• a. dissolving the peptide, or salt thereof, in at least one organic solvent miscible in water, and optionally containing also water, to form a water phase;
• b. forming an oil-in-water or water-in-oil-water emulsion in a suitable oil phase comprising an organic solution of the poly(D,L lactide-co-glycolide) polymer, the solution being non-miscible with the water phase;
• c. evaporating the at least one organic solvent used in step a from the emulsion to form the microspheres by controlling the temperature during the evaporation step and increasing the temperature during the evaporation step.