| abstract |
The present invention relates to a composition of microparticles comprising a suspension of substantially amorphous protein microparticles, the composition providing a concentration of at least about 50 milligrams of said protein per milliliter of the composition, and the protein has a molecular weight of when minus about 25,000 Daltones. According to the production method, the active agent is dissolved in an aqueous or water miscible solvent containing a dissolved phase separation enhancing agent (PSEA), to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spheres that are substantially amorphous or non-crystalline, and that can be injected through fine gauge needles at high concentrations. The invention has a special application for proteins of higher molecular weight. |