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1. 发明申请

WO2007053533A3 SODIUM CHLORIDE SOLUTION FOR DRUG RECONSTITUTION OR DILUTION 审中-公开
标题翻译：用于药物重组或稀释的氯化钠溶液
公开(公告)号：WO2007053533A3
公开(公告)日：2007-12-06
申请号：PCT/US2006042258
申请日：2006-10-27
申请人： WYETH CORP , WEBB CHANDRA A , ZERFAS JULIE
发明人： WEBB CHANDRA A , ZERFAS JULIE
IPC分类号： A61K9/08 , A61K38/48 , A61K47/02 , A61K47/18 , A61K47/26
CPC分类号： A61K47/02 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K38/4846 , A61K47/183 , A61K47/22 , A61K47/26
摘要： The invention provides methods for preparing pharmaceutical formulations for injection such that upon injection the formulation does not cause erythrocyte agglutination, hemolysis, and/or cell shrinkage. To prevent agglutination, a pharmaceutical formulation ready for injection needs to have a sufficient ionic strength. To prevent hemolysis or cell shrinkage, a pharmaceutical formulation ready for injection needs to be about isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both the sufficient ionic strength to prevent agglutination and the requisite tonicity to prevent significant hemolysis or cell dehydration or shrinkage. The present methods involve the use of sodium chloride solutions that are about 25 mM to about 150 mM for reconstituting lyophilized cakes (or other non-liquid pharmaceutical formulations) into solution or for diluting pharmaceutical formulation solutions.
摘要翻译：本发明提供了制备用于注射的药物制剂的方法，使得注射后制剂不会引起红细胞凝集，溶血和/或细胞收缩。为了防止凝集，准备用于注射的药物制剂需要具有足够的离子强度。为了防止溶血或细胞收缩，准备用于注射的药物制剂需要与血浆有关的等渗。本发明提供制备用于注射的药物制剂的方法，其具有足以防止凝集的足够离子强度和必需的张力以防止显着的溶血或细胞脱水或收缩。本发明方法涉及使用约25mM至约150mM的氯化钠溶液来将冻干饼（或其他非液体药物制剂）重构成溶液或用于稀释药物制剂溶液。

2. 发明申请

WO2004091487A3 HEMOPHILIA TREATMENT BY INHALATION OF COAGULATION FACTORS 审中-公开
标题翻译：通过吸入凝血因子治疗的HEMOPHILIA治疗
公开(公告)号：WO2004091487A3
公开(公告)日：2005-05-06
申请号：PCT/US2004010833
申请日：2004-04-08
申请人： WYETH CORP , NEKTAR THERAPEUTICS , SCHAUB ROBERT G , DORNER ANDREW J , GONG DAVID K , HASTEDT JAYNE E , WEBB CHANDRA A , KEITH JAMES C JR
发明人： SCHAUB ROBERT G , DORNER ANDREW J , GONG DAVID K , HASTEDT JAYNE E , WEBB CHANDRA A , KEITH JAMES C JR
IPC分类号： A61J3/02 , A61K20060101 , A61K9/00 , A61K9/12 , A61K9/16 , A61K38/00 , A61K38/37 , A61K38/48 , A61L9/04 , A61M11/02 , A61M15/00
CPC分类号： A61M15/0028 , A61K9/0075 , A61K9/1611 , A61K9/1617 , A61K9/1623 , A61K38/4846 , A61M11/02 , A61M2202/064
摘要： Hemophilia treatment by the inhalation of coagulation factors. Dry powder Factor IX is aerosolized to a mass median aerodynamic diameter of 4 µm or less, with at least 90% monomer content, at least 80% activity level, and 10% water or less. The aerosol is slowly, and deeply inhaled into the lung, and followed by a maximal exhale.
摘要翻译：血友病治疗吸入凝血因子。干粉因子IX雾化至4μm或更小的质量中值空气动力学直径，具有至少90％的单体含量，至少80％的活性水平和10％的水或更少的水分。气溶胶缓慢吸入肺部，最后呼气。

3. 发明申请

WO2007053533A2 SODIUM CHLORIDE SOLUTION FOR DRUG RECONSTITUTION OR DILUTION 审中-公开
标题翻译：氯化钠溶液用于药物重新配制或稀释
公开(公告)号：WO2007053533A2
公开(公告)日：2007-05-10
申请号：PCT/US2006/042258
申请日：2006-10-27
申请人： WYETH , WEBB, Chandra, A. , ZERFAS, Julie
发明人： WEBB, Chandra, A. , ZERFAS, Julie
IPC分类号： A61K9/08 , A61K47/02 , A61K47/18 , A61K47/26 , A61K38/48
CPC分类号： A61K47/02 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K38/4846 , A61K47/183 , A61K47/22 , A61K47/26
摘要： The invention provides methods for preparing pharmaceutical formulations for injection such that upon injection the formulation does not cause erythrocyte agglutination, hemolysis, and/or cell shrinkage. To prevent agglutination, a pharmaceutical formulation ready for injection needs to have a sufficient ionic strength. To prevent hemolysis or cell shrinkage, a pharmaceutical formulation ready for injection needs to be about isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both the sufficient ionic strength to prevent agglutination and the requisite tonicity to prevent significant hemolysis or cell dehydration or shrinkage. The present methods involve the use of sodium chloride solutions that are about 25 mM to about 150 mM for reconstituting lyophilized cakes (or other non-liquid pharmaceutical formulations) into solution or for diluting pharmaceutical formulation solutions.
摘要翻译：本发明提供制备用于注射的药物制剂的方法，使得在注射时制剂不引起红细胞凝集，溶血和/或细胞收缩。为了防止凝集，准备注射的药物制剂需要具有足够的离子强度。为了防止溶血或细胞收缩，准备注射的药物制剂关于等离子体需要约等渗。本发明提供了制备具有足够的离子强度以防止凝集和必需的张力以防止显着溶血或细胞脱水或收缩的注射用药物制剂的方法。本方法包括使用约25mM至约150mM的氯化钠溶液，用于将冻干的蛋糕（或其它非液体药物制剂）重构成溶液或稀释药物制剂溶液。

4. 发明申请

WO2007053533A8 SODIUM CHLORIDE SOLUTION FOR DRUG RECONSTITUTION OR DILUTION 审中-公开
标题翻译：氯化钠溶液用于药物重新配制或稀释
公开(公告)号：WO2007053533A8
公开(公告)日：2008-07-24
申请号：PCT/US2006042258
申请日：2006-10-27
申请人： WYETH CORP , WEBB CHANDRA A , ZERFAS JULIE
发明人： WEBB CHANDRA A , ZERFAS JULIE
IPC分类号： A61K9/08 , A61K38/48 , A61K47/02 , A61K47/18 , A61K47/26
CPC分类号： A61K47/02 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K38/4846 , A61K47/183 , A61K47/22 , A61K47/26
摘要： The invention provides methods for preparing pharmaceutical formulations for injection such that upon injection the formulation does not cause erythrocyte agglutination, hemolysis, and/or cell shrinkage. To prevent agglutination, a pharmaceutical formulation ready for injection needs to have a sufficient ionic strength. To prevent hemolysis or cell shrinkage, a pharmaceutical formulation ready for injection needs to be about isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both the sufficient ionic strength to prevent agglutination and the requisite tonicity to prevent significant hemolysis or cell dehydration or shrinkage. The present methods involve the use of sodium chloride solutions that are about 25 mM to about 150 mM for reconstituting lyophilized cakes (or other non-liquid pharmaceutical formulations) into solution or for diluting pharmaceutical formulation solutions.
摘要翻译：本发明提供制备用于注射的药物制剂的方法，使得在注射时制剂不引起红细胞凝集，溶血和/或细胞收缩。为了防止凝集，准备注射的药物制剂需要具有足够的离子强度。为了防止溶血或细胞收缩，准备注射的药物制剂关于等离子体需要约等渗。本发明提供了制备具有足够的离子强度以防止凝集和必需的张力以防止显着溶血或细胞脱水或收缩的注射用药物制剂的方法。本方法包括使用约25mM至约150mM的氯化钠溶液，用于将冻干的蛋糕（或其它非液体药物制剂）重构成溶液或稀释药物制剂溶液。

5. 发明申请

WO2004091487A2 HEMOPHILIA TREATMENT BY INHALATION OF COAGULATION FACTORS 审中-公开
标题翻译：通过吸入凝血因子治疗的HEMOPHILIA治疗
公开(公告)号：WO2004091487A2
公开(公告)日：2004-10-28
申请号：PCT/US2004/010833
申请日：2004-04-08
申请人： WYETH , NEKTAR THERAPEUTICS , SCHAUB, Robert, G. , DORNER, Andrew, J. , GONG, David, K. , HASTEDT, Jayne, E. , WEBB, Chandra, A. , KEITH, James, C., Jr.
发明人： SCHAUB, Robert, G. , DORNER, Andrew, J. , GONG, David, K. , HASTEDT, Jayne, E. , WEBB, Chandra, A. , KEITH, James, C., Jr.
IPC分类号： A61K
CPC分类号： A61M15/0028 , A61K9/0075 , A61K9/1611 , A61K9/1617 , A61K9/1623 , A61K38/4846 , A61M11/02 , A61M2202/064
摘要： Hemophilia treatment by the inhalation of coagulation factors. Dry powder Factor IX is aerosolized to a mass median aerodynamic diameter of 4 µm or less, with at least 90% monomer content, at least 80% activity level, and 10% water or less. The aerosol is slowly, and deeply inhaled into the lung, and followed by a maximal exhale.
摘要翻译：血友病治疗吸入凝血因子。干粉因子IX雾化至4μm或更小的质量中值空气动力学直径，具有至少90％的单体含量，至少80％的活性水平和10％的水或更少的水分。气溶胶缓慢吸入肺部，最后呼气。

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