发明名称 |
NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS |
摘要 |
<p>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.</p> |
申请公布号 |
CA2634663(A1) |
申请公布日期 |
2000.08.24 |
申请号 |
CA20002634663 |
申请日期 |
2000.02.22 |
申请人 |
BAXTER INTERNATIONAL INC.;UNIVERSITY OF CONNECTICUT |
发明人 |
KASHI, RAMESH;PIKAL, MICHAEL;BESMAN, MARC;BJORNSON, ERIK;JAMEEL, FEROZ;CARPENTER, JOHN;TCHESSALOV, SERGUEI |
分类号 |
A61K38/37;A61K47/36;A61K9/19;A61K38/43;A61K47/02;A61K47/10;A61K47/14;A61K47/18;A61K47/20;A61K47/22;A61K47/26;A61K47/34;A61K47/42;A61P7/04 |
主分类号 |
A61K38/37 |
代理机构 |
|
代理人 |
|
主权项 |
|
地址 |
|