发明名称 Tigecycline compositions and methods of preparation
摘要 The present invention relates to novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions. These compositions comprise tigecycline, a suitable carbohydrate, and an acid or buffer.
申请公布号 US8975242(B2) 申请公布日期 2015.03.10
申请号 US201113011164 申请日期 2011.01.21
申请人 Wyeth LLC 发明人 Fawzi Mahdi B.;Zhu Tianmin;Shah Syed M.
分类号 A01N37/18;A01N43/42;A61K31/65;A61K31/44;A61K9/08;A61K9/00;A61K9/19;A61K47/26 主分类号 A01N37/18
代理机构 代理人 Joran A. David
主权项 1. A composition comprising tigecycline, lactose, and an acid, wherein the molar ratio of tigecycline to lactose is between about 1:1.6 to about 1:3.3, and the pH of the composition in a solution is between about 4.0 and about 5.0, wherein the acid is hydrochloric acid, and the composition further comprises tigecycline epimer in an amount that is not more than 2.56% as measured after storage of the composition at about 40° C. and 75% relative humidity for not more 39 days.
地址 New York NY US