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
  • 申请号: EP15701164.4
    申请日: 2015-01-20
  • 公开(公告)号: EP3096743A1
    公开(公告)日: 2016-11-30
  • 发明人: PAYET-BURIN, Xavier
  • 申请人: EveonUCB 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
PROCESS FOR RECONSTITUTION OF A SOLID FORM OF A PHARMACEUTICAL COMPOSITION
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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