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公开(公告)号：US07087723B2
公开(公告)日：2006-08-08
申请号：US10610723
申请日：2003-07-01
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US20080176791A1
公开(公告)日：2008-07-24
申请号：US11764770
申请日：2007-06-18
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K38/37
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US07247707B2
公开(公告)日：2007-07-24
申请号：US11434634
申请日：2006-05-15
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US08058226B2
公开(公告)日：2011-11-15
申请号：US11764770
申请日：2007-06-18
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US20060205661A1
公开(公告)日：2006-09-14
申请号：US11434634
申请日：2006-05-15
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US08372800B2
公开(公告)日：2013-02-12
申请号：US13250789
申请日：2011-09-30
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K38/00 , A61K38/16 , A61K35/14 , A61K47/00 , A61K31/715 , A61K51/00 , A01N43/04 , C07K1/00 , C07K14/00 , C07K16/00 , C07K17/00
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： An albumin-free Factor VIII formulation comprising: 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. 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. 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.
摘要翻译： 不含白蛋白的因子VIII制剂，其包含：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 和缓冲剂。 或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 和缓冲剂。 在另一个实施方案中，制剂可包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US20120083446A1
公开(公告)日：2012-04-05
申请号：US13250789
申请日：2011-09-30
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： An albumin-free Factor VIII formulation comprising, 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 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. 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.
摘要翻译： 不含白蛋白的因子VIII制剂，其包含4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 和缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 和缓冲剂。 在另一个实施方案中，制剂可包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US06586573B1
公开(公告)日：2003-07-01
申请号：US09507011
申请日：2000-02-22
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K3514
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
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.
摘要翻译： 不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。
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公开(公告)号：US20100168018A1
公开(公告)日：2010-07-01
申请号：US12614090
申请日：2009-11-06
申请人： Michael Pikal , Serguei Tchessalov , Erik Bjornson , Feroz Jameel , Marc Besman
发明人： Michael Pikal , Serguei Tchessalov , Erik Bjornson , Feroz Jameel , Marc Besman
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/20 , A61K47/26
摘要： A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.
摘要翻译： 配制的因子VIII（FVIII）组合物使得NaCl不存在于最终制剂中或以微量存在，这允许冻干周期时间的伴随减少和冻干FVIII的稳定性增加。
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