Pharmaceutical preparation of recombinant factor viii...

A - Human Necessities – 61 – K

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Details

A61K 38/37 (2006.01) A61K 9/19 (2006.01) A61K 47/18 (2006.01) A61P 7/04 (2006.01)

Patent

CA 2504377

Disclosed is a lyophilized preparation of recombinant factor VIII used as a therapeutic preparation of hemophilia A. The lyophilized preparation of recombinant factor VIII is prepared by performing lyophilization using a mixture comprising 6 to 100 mM of L-arginine, 3.5 to 50 mM of L-isoleucine, and 10 to 100 mM of L-glutamic acid as a stabilizer for stabilizing the recombinant factor VIII which exhibits an unstable activity during lyophilization, rather than using human blood derived albumin.

L'invention divulgue une préparation lyophilisée de facteur VIII recombinant utilisée en tant que préparation thérapeutique traitant l'hémophilie A. La préparation lyophilisée de facteur VIII recombinant est préparée par une lyophilisation réalisée avec un mélange contenant 6 à 100 mM de L-arginine, 3,5 à 50 mM de L-isoleucine, et 10 à 100 mM d'acide L-glutamique comme stabilisant du facteur VIII recombinant, qui est instable durant la lyophilisation, plutôt que l'albumine humaine dérivée du sang.

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