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    • 3. 发明申请
    • DEXRAZOXANE FORMULATIONS AND METHODS
    • 异噻唑酮制剂和方法
    • WO2007062076A2
    • 2007-05-31
    • PCT/US2006045125
    • 2006-11-20
    • NOVARTIS AGOKHAMAFE AUGUSTUSHORA MININDERFAKES DAVIDWEI REBECCADANI BHASHASHASH AHMAD
    • OKHAMAFE AUGUSTUSHORA MININDERFAKES DAVIDWEI REBECCADANI BHASHASHASH AHMAD
    • A61K31/495A61K9/19A61P31/00
    • A61K9/0019A61K9/19A61K31/495
    • Improved formulations of dexrazoxane for making injectable solutions in a clinical setting are provided. In some embodiments, high pH formulations are provided to reduce or eliminate pain upon injection. According to various embodiments, dexrazoxane may be formulated as a lyophilized or non-lyophilized acid salt or as a lyophilized or non-lyophilized free base. In some embodiments, dexrazoxane is provided as a sterile dry milled powder of a free base or an isolated acid salt crystal. Formulations that require significantly reduced clinical preparation time are provided. Single-container presentations of unit doses of dexrazoxane are also provided. The formulations of the present invention may be provided in a vial, infusion bottle or infusion bag. In some embodiments, the container may be directly attachable to a diluent-containing container for easy preparation. In other embodiments, diluent may be added directly to the container. Improved methods of manufacturing dexrazoxane that allow greater processing latitude are also provided.
    • 提供了用于在临床环境中制备可注射溶液的右旋唑烷的改进制剂。 在一些实施方案中,提供高pH制剂以减少或消除注射时的疼痛。 根据各种实施方案,地塞米松可以配制成冻干或非冻干的酸盐或冻干或非冻干的游离碱。 在一些实施方案中,将脱甲硅烷作为游离碱或分离的酸盐晶体的无菌干研磨粉末提供。 提供需要显着减少临床准备时间的制剂。 还提供了单位剂量的地塞米松的单容器介绍。 本发明的制剂可以提供在小瓶,输液瓶或输液袋中。 在一些实施方案中,容器可以直接附接到含稀释剂的容器以便于制备。 在其它实施方案中,可以将稀释剂直接加入到容器中。 还提供了改进的允许更大加工纬度的地塞米松的制造方法。