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Albumin-free factor VIII formulations
专利权人:
John Carpenter;Marc Besman;Erik Bjornson;Feroz Jameel;Ramesh Kashi;Michael Pikal;Serguei Tchessalov
发明人:
Marc Besman,Erik Bjornson,Feroz Jameel,Ramesh Kashi,Michael Pikal,Serguei Tchessalov,John Carpenter
申请号:
US13250789
公开号:
US08372800B2
申请日:
2011.09.30
申请国别(地区):
US
年份:
2013
代理人:
摘要:
An albumin-free Factor VIII formulation comprising: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
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