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1. 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。

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