- 专利标题: Albumin-free factor VIII formulations
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申请号: US14286391申请日: 2014-05-23
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公开(公告)号: US09352027B2公开(公告)日: 2016-05-31
- 发明人: Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
- 申请人: Baxter International Inc.
- 申请人地址: US IL Bannockburn unknown Glattpark (Opfikon) US CT Farmington
- 专利权人: Baxalta Incorporated,Baxalta GmbH,University of Connecticut
- 当前专利权人: Baxalta Incorporated,Baxalta GmbH,University of Connecticut
- 当前专利权人地址: US IL Bannockburn unknown Glattpark (Opfikon) US CT Farmington
- 代理机构: Morgan, Lewis & Bockius LLP
- 主分类号: A61K38/37
- IPC分类号: A61K38/37 ; A61K9/00 ; A61K9/19 ; A61K47/02 ; A61K47/10 ; A61K47/18 ; A61K47/38 ; A61K47/26
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
- US20150025010A1 NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS 公开/授权日:2015-01-22
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