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    PRESERVATIVE-FREE TREPROSTINIL FORMULATIONS AND METHODS AND DEVICES FOR USE WITH SAME
    2.
    发明申请
    PRESERVATIVE-FREE TREPROSTINIL FORMULATIONS AND METHODS AND DEVICES FOR USE WITH SAME 审中-公开
    无防腐剂的蛇纹霉素制剂和方法以及与其一起使用的装置

    公开(公告)号：WO2016088119A1

    公开(公告)日：2016-06-09

    申请号：PCT/IL2015/051098

    申请日：2015-11-15

    申请人： STEADYMED LTD

    发明人： RIGBY, Jonathan ,  NOYMER, Peter ,  ZWOLINSKI, Robert

    IPC分类号： A61K9/00 ,  A61K31/5575 ,  A61P9/12

    CPC分类号： A61K31/5575 ,  A61K9/0019 ,  A61M5/14248 ,  C07C39/17 ,  C07C59/72 ,  C07C405/0075

    摘要： This invention provides for a unit dosage form of treprostinil at a dosage of between 0.1 mg/mL and 25 mg/mL in a sterile fluid composition formulated for subcutaneous or intravenous injection, which composition does not comprise an antimicrobial preservative. Selectively activatable patch-pump assemblies comprising a sealed prefilled drug-reservoir containing the unit dosage form is described as are methods for reducing pain at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof, and methods of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof. The invention also provides a method of treating pulmonary hypertension, and methods for treating, or reducing the severity or reducing the pathogenesis of Pulmonary arterial hypertension (PAH) in a subject making use of the compositions as herein described.

    摘要翻译： 本发明在配制用于皮下或静脉内注射的无菌液体组合物中以0.1mg / mL至25mg / mL的剂量提供曲前列素的单位剂量形式，该组合物不包含抗微生物防腐剂。 包含含有单位剂型的密封预填充药物储存器的选择性活化的贴片泵组件被描述为用于在有需要的受试者中减少曲前列素的皮下或静脉内输注部位的疼痛的方法，以及减少刺激，炎症的方法 或其组合在有需要的受试者皮下或静脉内输注曲前列素的部位。 本发明还提供一种治疗肺动脉高压的方法，以及在使用本文所述组合物的受试者中治疗肺动脉高压（PAH）的严重程度或降低其发病机制的方法。