| 发明名称 |
STABLE INTRAVENOUS FORMULATION |
| 摘要 |
;A stable lyophilized formulation for intravenous administration of the compound 4-{[(2R, 3S, 55)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)- pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic Acid 1-[2-(2-methoxy-ethoxy)-ethoxycarbonyloxy]-ethyl ester is provided. |
| 申请公布号 |
US2016136280(A1) |
申请公布日期 |
2016.05.19 |
| 申请号 |
US201414898122 |
申请日期 |
2014.06.20 |
| 申请人 |
HOFFMANN-LA ROCHE INC. |
发明人 |
Galasso Anthony N.;Inbar Petra;Qureshi Farooq;Sampat Harendra R.;Zhan Shangdong |
| 分类号 |
A61K47/26;A61K47/22;A61K9/00;A61K31/40 |
主分类号 |
A61K47/26 |
| 代理机构 |
|
代理人 |
|
| 主权项 |
1. A pharmaceutical formulation, comprising from about 0.1 mg to about 100 mg of 4-{[(2R, 3S, 5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2- dimethyl-propyl)-pyrrolidine-2-carbonyl]amino}-3-methoxy-benzoic Acid 1-[2-(2-methoxy-ethoxy)-ethoxycarbonyloxy]-ethyl ester of Compound Afrom about 10 mM to about 100 mM of a buffering agent, from about 25 mg to about 125 mg of a lyophilization bulking agent and an isotonicity builder having a pH of from about 5 to about 7, in a final reconstitution volume of 1 ml. |
| 地址 |
Nutley NJ US |
