Liquid stabilized protein formulations in coated pharmaceutical containers
    1.
    发明公开
    Liquid stabilized protein formulations in coated pharmaceutical containers 审中-公开
    StabilisierteFlüssigeProteinzubereitungen在beschichteten pharmazeutischenBehältnissen

    公开(公告)号:EP2324845A1

    公开(公告)日:2011-05-25

    申请号:EP11152658.8

    申请日:2004-05-12

    申请人: Ares Trading S.A.

    IPC分类号: A61K38/21 A61J1/00

    摘要: A container comprising a closure means coated by an inert fluorinated material and containing a liquid pharmaceutical composition. In particular, the container comprises a closure means coated by TEFLON and contains a HSA-free Interferon-β formulation having the following composition: 30 to 100 µg/ml of interferon-β, an isotonicity agent, 0.1 to 2 mg/ml of Poloxamer 188, at least 0.12 mg/ml of L-Methionine and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0.

    摘要翻译: 一种容器,其包括用惰性氟化材料涂覆并含有液体药物组合物的封闭装置。 特别地,容器包括由TEFLON涂覆的封闭装置,并且包含具有以下组成的无HSA干扰素-2制剂:30至100μg/ ml干扰素-2,等渗剂,0.1至2mg / ml泊洛沙姆 188,至少0.12mg / ml的L-甲硫氨酸和能够将液体制剂的pH保持在3.0和4.0之间的值的缓冲溶液。