LOW PH PHARMACEUTICAL COMPOSITIONS OF RECOMBINANT BETA-INTERFERON

摘要

Stable pharmaceutical compositions suitable for parenteral administration to mammals are prepared which are in a pH range of about 2 to about 4 and comprise a therapeutically effective amount of a recombinant interferon- beta protein (IFN- beta ) dissolved in an inert carrier medium comprising as a stabilizer/solubilizer an effective amount either of glycerol or of polyethylene glycol polymers having an average molecular weight from about 190 to about 1600 daltons. Further disclosed and claimed are methods for extracting IFN- beta from a microbial host transformed to produce it and then purifying and formulating said IFN- beta and methods for screening for other polyhydric non-detergent stabilizer/solubilizers or combinations thereof as solubilizer/stabilizers for pharmaceutical compositions of IFN- beta .