Original document(28 pages)  中文版
    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.
Application Number
申请号
00806304 Application Date
申请日
2000.02.22
Title 名称 Novel albumin-free factor VIII formulations
Publication Number
公开号
1399560 Publication Date
公开日
2003.02.26
Approval Pub. Date Granted Pub. Date
International Classification 分类号 A61K9/19;A61K47/02;A61K47/10;A61K47/18;A61P7/04
Applicant(s) Name
申请人
Baxter International Inc.
Address 地址
Inventor(s) Name 发明人 M. Besman;E. Bjornson;F. Jameel et.al
Attorney & Agent 代理人 guo anxun
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