发明名称 |
Stable Solid Formulation of a GC-C Receptor Agonist Polypeptide Suitable for Oral Administration |
摘要 |
Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (“linaclotide”; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug. |
申请公布号 |
US2014287034(A1) |
申请公布日期 |
2014.09.25 |
申请号 |
US201414286062 |
申请日期 |
2014.05.23 |
申请人 |
Ironwood Pharmaceuticals, Inc. ;Forest Laboratories Holdings Limited |
发明人 |
Fretzen Angelika;Witowski Steven;Grossi Alfredo;Zhao Hong;Dedhiya Mahendra;Mo Yun |
分类号 |
A61K9/50;G01N30/02;A61K47/18;A61K47/36;A61K38/12;A61K47/02 |
主分类号 |
A61K9/50 |
代理机构 |
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代理人 |
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主权项 |
1. A pharmaceutical composition comprising linaclotide and a pharmaceutically acceptable excipient, wherein the chromatographic purity of the linaclotide decreases by less than 10% after (a) 18 months of storage of the pharmaceutical composition at 25° C. at 60% relative humidity in a sealed container containing a desiccant or (b) 6 months of storage of the pharmaceutical composition at 40° C. at 75% relative humidity in a sealed container containing a desiccant. |
地址 |
Cambridge MA US |