发明申请
- 专利标题: STABLE FORMULATIONS OF POLYPEPTIDES AND USES THEREOF
- 专利标题(中): 稳定的多肽制剂及其用途
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申请号: US13393636申请日: 2010-09-03
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公开(公告)号: US20120244158A1公开(公告)日: 2012-09-27
- 发明人: Ann Brige , Veronique De Brabandere
- 申请人: Ann Brige , Veronique De Brabandere
- 申请人地址: BE Zwijnaarde
- 专利权人: Ablynx N.V.
- 当前专利权人: Ablynx N.V.
- 当前专利权人地址: BE Zwijnaarde
- 国际申请: PCT/EP2010/062975 WO 20100903
- 主分类号: A61K39/395
- IPC分类号: A61K39/395
摘要:
Formulations are provided that contain single variable domains with a good solubility and good stability under different storage, transportation and stress conditions. The formulations are useful as pharmaceutical formulation. The formulation comprises an aqueous carrier with a pH of 5.5 to 8.0, a buffer selected from the group consisting of histidine pH 6.0-6.5, hepes pH 7.0-8.0, MES pH 6.0, succinate pH 6.0-6.5 and acetate pH 5.5-6.0; an excipient; and/or a surfactant selected from Tween 80, Tween 20 and poloxamers. The formulation is further characterized that it has an inorganic salt concentration of 150 mM or lower. The invention further relates to containers and pharmaceutical units comprising such formuSations and to methods for preparing and prophylactic and therapeutic uses of the formulations and pharmaceutical units of the invention.
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