Low ph pharmaceutical compositions of recombinant...

Details Low ph pharmaceutical compositions of recombinant... Low ph pharmaceutical compositions of recombinant...

C - Chemistry, Metallurgy

07

K

167/103.1

C07K 14/565 (2006.01) A61K 47/02 (2006.01) A61K 47/10 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1335255

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..

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