发明公开
EP3096743A1 PROCESS FOR RECONSTITUTION OF A SOLID FORM OF A PHARMACEUTICAL COMPOSITION
审中-公开
VERFAHREN ZUR REKONSTITUTION EINER FESTEN FORE EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG
- 专利标题: PROCESS FOR RECONSTITUTION OF A SOLID FORM OF A PHARMACEUTICAL COMPOSITION
- 专利标题(中): VERFAHREN ZUR REKONSTITUTION EINER FESTEN FORE EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG
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申请号: EP15701164.4申请日: 2015-01-20
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公开(公告)号: EP3096743A1公开(公告)日: 2016-11-30
- 发明人: PAYET-BURIN, Xavier
- 申请人: Eveon , UCB Biopharma SPRL
- 申请人地址: 345 rue Lavoisier Zirst 2, Innovallée 38330 Montbonnot Saint Martin FR
- 专利权人: Eveon,UCB Biopharma SPRL
- 当前专利权人: Eveon,UCB Biopharma SPRL
- 当前专利权人地址: 345 rue Lavoisier Zirst 2, Innovallée 38330 Montbonnot Saint Martin FR
- 代理机构: Regimbeau
- 优先权: EP14305070 20140120
- 国际公布: WO2015107214 20150723
- 主分类号: A61K9/19
- IPC分类号: A61K9/19
摘要:
The invention relates to a process for reconstitution of a solid form of a pharmaceutical composition, comprising the following successive steps: (i) providing the solid form of the pharmaceutical composition in a sealed container, the pressure within the container being an initial pressure (pi) comprised between 0.5 Pa and 1.2×105 Pa; (ii) at a first time point (t0) introducing the solvent into said sealed container and maintaining the resulting pressure (pr) within the container during a controlled time Δt1; and (iii) at a second time point (t2) increasing the pressure within the container to a controlled pressure (p2) higher than said resulting pressure (pr) until complete reconstitution.
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