发明授权
- 专利标题: Long-acting colloidal insulin formulation and its preparation
- 专利标题(中): 长效胶体胰岛素制剂及其制备
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申请号: US11632992申请日: 2005-06-09
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公开(公告)号: US08017156B2公开(公告)日: 2011-09-13
- 发明人: Alain Constancis , Florence Nicolas , Rémi Meyrueix , Olivier Soula
- 申请人: Alain Constancis , Florence Nicolas , Rémi Meyrueix , Olivier Soula
- 申请人地址: FR
- 专利权人: Flamel Technologies
- 当前专利权人: Flamel Technologies
- 当前专利权人地址: FR
- 代理机构: Patton Boggs LLP
- 优先权: FR0451578 20040719
- 国际申请: PCT/FR2005/050431 WO 20050609
- 国际公布: WO2006/016078 WO 20060216
- 主分类号: A61K9/14
- IPC分类号: A61K9/14 ; A61K38/28
摘要:
The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals.The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route.To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270≦O≦800, and the viscosity v (in mPa·s) is low, namely v≦40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15≦Dh≦40.The invention relates to an antidiabetic drug based on this long-acting insulin formulation and injectable using needles of gauge 29 G, 30 G or 31 G.
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