| 发明名称 | Pharmaceutical compositions of amlodipine and valsartan | ||
| 摘要 | A single layer pharmaceutical composition comprising active agent(s) amlodipine or a pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt thereof wherein the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprising amlodipine besylate and valsartan; when administered to human subject, under the bioequivalence parameters of a 90% Confidence Interval for AUC which is between 80% and 125%, and a 90% Confidence Interval for Cmax, which is between 80% and 125%. | ||
| 申请公布号 | US8785432(B2) | 申请公布日期 | 2014.07.22 |
| 申请号 | US200812810662 | 申请日期 | 2008.02.21 |
| 申请人 | Lupin Limited | 发明人 | Kute Anirudha Bhagirath;Malewar Nikhil Prabhakar;Avachat Makarand Krishnakumar |
| 分类号 | A61K31/54;A01N43/40 | 主分类号 | A61K31/54 |
| 代理机构 | Merchant & Gould P.C. | 代理人 | Merchant & Gould P.C. |
| 主权项 | 1. A single layer pharmaceutical composition comprising active agent(s) (a) amlodipine or a pharmaceutically acceptable salt thereof and (b) valsartan or a pharmaceutically acceptable salt thereof wherein: (i) the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprising amlodipine besylate and valsartan; when administered to a human subject, under the bioequivalence parameters of: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for Cmax, which is between 80% and 125%; and(ii) wherein valsartan is present in an amount less than 35% by weight, based on the total weight of the pharmaceutical composition. | ||
| 地址 | Mumbai, Maharashtra IN | ||