BAXTER INTERNATIONAL, INC.;UNIVERSITY OF CONNECTICUT; INC.;BAXTER INTERNATIONAL
发明人:
PIKAL, MICHAEL,TCHESSALOV, SERGUEI,BJORNSON, ERIK,JAMEEL, FEROZ,BESMAN, MARC
申请号：
NZ59319009
公开号：
NZ593190A
申请日:
2009.11.06
申请国别(地区):
NZ
年份:
2013
代理人:
摘要：
593190 Disclosed is a stable lyophilized pharmaceutical formulation of Factor VIII (FVIII) comprising: (a) a FVIII； (b) one or more buffering agents； (c) one or more antioxidants； (d) one or more stabilizing agents； and (e) one or more surfactants； said FVIII comprising a polypeptide selected from the group consisting of: a) a recombinant FVIII polypeptide； b) a biologically active analog, fragment or variant of a)； said buffering agent is at a concentration of about 0.1 mM to about 500 mM and said pH is in a range of about 2.0 to about 12.0； said antioxidant is at a concentration of about 0.005 to about 1.0 mg/ml； said stabilizing agent is at a concentration of about 0.005 to about 20% w/v or about 0.1 to 1000 mM； said surfactant is at a concentration of about 0.001 % to about 1.0% w/v； and said formulation excluding sodium chloride (NaCl) or including only trace amount of NaCl.
