Pharmaceutical preparation of recombinant factor VIII lyophilized without albumin as a stabilizer
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United States of America Patent
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May 3, 2005
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Aug 6, 2004
filing date -
Jun 25, 2004
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Abstract
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.
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