SUPERCRITICAL FLUIDS PROCESSING: PREPARATION OF PROTEIN MICROPARTICLES AND THEIR STABILISATION

摘要

A process for the co-precipitation of a substance with a stabiliser therefor , by a gas anti solvent process comprising introducing into a particle formati on vessel a supercritical fluid pure or mixed with a modifier; and a solution comprising said substance and said stabiliser dissolved in a solvent; so as said solvent is extracted from the solution by said supercritical fluid and co- precipitation of the substance and stabiliser occurs. The process may be carried out using an apparatus comprising a particle formation vessel (22) a nd a nozzle (27) having a central orifice (39) serving to introduce a solution of the substance and a plurality of outer orifices (41) serving to carry a flow of supercritical fluid into the particle formation vessel (22), such that th e solvent is extracted from the solution by the supercritical fluid and precipitation of micron sized particles of the substance/stabilizer occurs. The substance is preferably a protein of pharmaceutical interest, which is highly stabilized for storage by this process.