发明名称 |
STABLE PROTEIN FORMULATIONS COMPRISING A MOLAR EXCESS OF SORBITOL |
摘要 |
A stable pharmaceutical formulation comprising a protein of interest, sorbitol and polyethylene glycol (PEG). The sorbitol and protein is present in a molar ratio of 550 to 700 mole of sorbitol: 1 mole of protein and the PEG to protein is present in the molar ratio of 2-50:1. The formulation optionally comprising buffer. The formulation in lyophilised form is stable for at least 4 years at 2-8° C. Also provided is a process for preparing the composition and a pharmaceutical kit comprising the same. |
申请公布号 |
EP3131584(A1) |
申请公布日期 |
2017.02.22 |
申请号 |
EP20150721038 |
申请日期 |
2015.04.16 |
申请人 |
Biocon Limited;Mylan GmbH |
发明人 |
CHANDRAMOULI, Kala;PAI, Rohan |
分类号 |
A61K47/10;A61K9/19;A61K38/00;A61K47/26 |
主分类号 |
A61K47/10 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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