FACTOR VIII COMPOSITION FORMULATED WITHOUT ADDED ALBUMIN, USE OF A FACTOR VIII COMPOSITION, AND METHOD OF LYOPHILIZING A WATER PHARMACEUTICAL FORMULATION
BAXTER INTERNATIONAL INC.;UNIVERSITY OF CONNECTICUT;BAXTER HEALTHCARE SA.
发明人:
MARC BESMAN,FEROZ JAMEEL,RAMESH KASHI,MICHAEL PIKAL,SERGUEI TCHESSALOV,JOHN CARPENTER,ERIK BJORNSON
申请号：
BR0008405
公开号：
BR0008405B1
申请日:
2000.02.22
申请国别(地区):
BR
年份:
2014
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.
