AUTO-INJECTOR
    79.
    发明公开
    AUTO-INJECTOR 审中-公开
    自动注射器

    公开(公告)号:EP3099350A1

    公开(公告)日:2016-12-07

    申请号:EP15700757.6

    申请日:2015-01-22

    IPC分类号: A61M5/20 A61M5/24

    摘要: Provided is a cassette unit suitable for use with an auto-injector having a drive unit. The cassette unit comprises a cassette unit housing defining a cassette unit housing cavity, which is in receipt of a syringe, a rearward entrance to said cavity and a forward needle projection aperture. The cassette unit also comprises in capping relationship with the rearward entrance of the cassette unit housing, a cassette unit end-cap, said cassette unit end-cap defining a drive rod-receiving opening for receipt of a drive rod for providing forward axial drive to said plunger; a biasing element defining a biasing relationship between the cassette unit end-cap and an end flange of the syringe barrel, thereby urging the syringe forwards in relation to the cassette unit end-cap; and a damping element defining a damping relationship between the cassette unit end-cap and the flange of the syringe, thereby acting to damp rearward movement of the syringe relative to the cassette unit end-cap.

    摘要翻译: 提供一种适用于具有驱动单元的自动注射器的盒式单元。 盒单元包括盒单元壳体,所述盒单元壳体限定盒单元容纳腔,所述盒单元容纳腔接收注射器,所述腔的向后入口和前向针突出孔。 匣盒单元还包括与匣盒单元外壳的后部入口处于封盖关系的匣盒单元端盖,所述匣盒单元端盖限定用于接收驱动杆的驱动杆接收开口,以提供向前轴向驱动到 所述柱塞; 偏置元件,其限定所述盒单元端盖与所述注射器筒的端部凸缘之间的偏置关系,从而相对于所述盒单元端盖向前推动所述注射器; 以及阻尼元件,所述阻尼元件限定所述盒单元端盖和所述注射器的所述凸缘之间的阻尼关系,由此用于抑制所述注射器相对于所述盒单元端盖的向后移动。

    PROCESS FOR RECONSTITUTION OF A SOLID FORM OF A PHARMACEUTICAL COMPOSITION
    80.
    发明公开
    PROCESS FOR RECONSTITUTION OF A SOLID FORM OF A PHARMACEUTICAL COMPOSITION 审中-公开
    VERFAHREN ZUR REKONSTITUTION EINER FESTEN FORE EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG

    公开(公告)号:EP3096743A1

    公开(公告)日:2016-11-30

    申请号:EP15701164.4

    申请日:2015-01-20

    IPC分类号: A61K9/19

    CPC分类号: A61K9/0095 A61K9/19 A61K47/60

    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.

    摘要翻译: 本发明涉及重组固体形式的药物组合物的方法,其包括以下连续步骤:(i)将药物组合物的固体形式提供在密封容器中,容器内的压力为初始压力(pi )在0.5Pa和1.2×105Pa之间; (ii)在第一时间点(t0)将溶剂引入所述​​密封容器中并在受控时间Δt1期间将所得压力(pr)保持在容器内; 和(iii)在第二时间点(t2)将容器内的压力增加到高于所述所得压力(pr)的受控压力(p2)直到完全重构。