发明授权
- 专利标题： Albumin-free factor VIII formulations
- 专利标题（中）： 无白蛋白因子VIII配方
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申请号： US10610723申请日： 2003-07-01
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公开(公告)号： US07087723B2公开(公告)日： 2006-08-08
- 发明人: Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
- 申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
- 申请人地址： US IL Deerfield US CT Farmington
- 专利权人： Baxter International Inc.,University of Connecticut
- 当前专利权人： Baxter International Inc.,University of Connecticut
- 当前专利权人地址： US IL Deerfield US CT Farmington
- 代理机构： Townsend and Townsend and Crew LLP
- 主分类号： A61K35/14
- IPC分类号： A61K35/14 ; A61K38/16
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.
公开/授权文献
- US20040116345A1 Novel albumin-free factor VIII formulations 公开/授权日：2004-06-17
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