LIQUID PHARMACEUTICAL COMPOSITION
    14.
    发明公开
    LIQUID PHARMACEUTICAL COMPOSITION 审中-公开
    FLÜSSIGEPHARMAZEUTISCHE ZUSAMMENSETZUNG

    公开(公告)号:EP3053573A1

    公开(公告)日:2016-08-10

    申请号:EP15193532.7

    申请日:2015-11-06

    申请人: ARES TRADING S.A.

    摘要: The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, and at least one component selected from the group consisting of: a polyvinylpyrrolidone (PVP) surfactant, an inositol sugar stabiliser, and a gluconate salt toncifier. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.

    摘要翻译: 本发明涉及阿达木单抗的新型液体药物组合物,其包括阿达木单抗或其生物相似物,以及至少一种选自聚乙烯吡咯烷酮(PVP)表面活性剂,肌醇糖稳定剂和葡萄糖酸盐调味剂的组分。 这样的组合组合物提供具有稳定性(例如在储存和暴露于应力时)的制剂,其与本领域已知的那些相当或者改进,并且具有较少的成分。 这些进展将有助于阿达木单抗治疗以更低的成本更广泛地获得,并且延长预加载递送装置(例如预装注射器)的生存能力,以减少不必要的药物浪费。