| 发明名称 |
PROCESS FOR PREPARING STERILE BRINZOLAMIDE |
| 摘要 |
Process of preparing sterile brinzolamide using ethylene-oxide gas sterilisation, sterile brinzolamide obtainable by said process and pharmaceutical compositions comprising said sterile brinzolamide. |
| 申请公布号 |
US2015065493(A1) |
申请公布日期 |
2015.03.05 |
| 申请号 |
US201314385232 |
申请日期 |
2013.03.15 |
| 申请人 |
AZAD Pharmaceutical Ingredients AG |
发明人 |
Khov-Tran Van Van;Porstmann Frank;Ondracek Jan;Grams Gregory |
| 分类号 |
A61L2/18;A61K31/542 |
主分类号 |
A61L2/18 |
| 代理机构 |
|
代理人 |
|
| 主权项 |
1. A process for sterilizing an active pharmaceutical ingredient (API) comprising the steps of
(i) providing a API product, and (ii) contacting said API product with ethylene oxide, under conditions that at most 0.5% by weight of degradation products are formed during step (ii),wherein the concentration of ethylene oxide in step (ii) is in the range of 300-450 mg/1, and wherein the contacting time in step (ii) is in the range of 20-100 minutes. |
| 地址 |
Schaffhausen CH |
