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Albumin-Free Factor VIII preparations
专利权人:
UNIVERSITY OF CONNECTICUT;BAXTER INTERNATIONAL INC.
发明人:
BESMAN, MARC,BJORNSON, ERIK,KASHI, RAMESH,PIKAL, MICHAEL,TCHESSALOV, SERGUEI,CARPENTER, JOHN,JAMEEL, FEROZ
申请号:
DK09075396
公开号:
DK2130554T3
申请日:
2000.02.22
申请国别(地区):
DK
年份:
2012
代理人:
摘要:
A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 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 for maintaining a pH of approximately between 6 and 8. 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 for maintaining a pH of approximately between 6 and 8. 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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