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 |