Bendamustine Formulations
    2.
    发明申请
    Bendamustine Formulations 有权
    苯达莫司汀制剂

    公开(公告)号:US20140080880A1

    公开(公告)日:2014-03-20

    申请号:US14030201

    申请日:2013-09-18

    CPC classification number: A61K31/4184 A61K9/0019 A61K9/19 A61K47/26

    Abstract: A lyophilized bendamustine composition consisting of bendamustine hydrochloride, an aqueous solvent, and optionally an excipient, and a method of preparation thereof for treating a condition in a subject are provided. The aqueous solvent includes, for example, water, an acid, a base, or a salt, etc. The excipient includes at least one cryoprotectant, for example, sucrose, trehalose, mannitol, etc. A pre-lyophilization bendamustine composition is lyophilized, for example, by freezing, primary drying, annealing, secondary drying, condensed cooling and evacuation at preset temperatures to obtain the lyophilized bendamustine composition as a cake, a powder, or a solid concentrate. The lyophilized bendamustine composition is free of a non-aqueous solvent. Reconstitution is performed by mixing the lyophilized bendamustine composition with an aqueous solvent for about 30 seconds to 300 seconds. The reconstituted bendamustine product containing about 0.2 wt % to about 2.5 wt % by weight of impurities is administered to the subject in need thereof.

    Abstract translation: 提供了由盐酸苯达莫司汀,水性溶剂和任选的赋形剂组成的冻干的苯达莫司汀组合物及其用于治疗受试者的病症的制备方法。 水性溶剂包括例如水,酸,碱或盐等。赋形剂包括至少一种冷冻保护剂,例如蔗糖,海藻糖,甘露醇等。将冻干前冻干抑制药组合物冻干, 例如通过冷冻,初次干燥,退火,二次干燥,冷凝冷却和在预设温度下排空,以获得作为饼状物,粉末或固体浓缩物的冻干的苯达莫司汀组合物。 冻干的苯达莫司汀组合物不含非水溶剂。 通过将冻干的苯达莫司汀组合物与水性溶剂混合约30秒至300秒进行重构。 将含有约0.2重量%至约2.5重量%杂质的复原苯达莫司汀产品施用于有需要的受试者。

    Aprepitant Injectable Formulations
    3.
    发明申请
    Aprepitant Injectable Formulations 审中-公开
    阿维地丁注射剂

    公开(公告)号:US20130317016A1

    公开(公告)日:2013-11-28

    申请号:US13901978

    申请日:2013-05-24

    Abstract: An aqueous stable and ready-to-use formulation of aprepitant is prepared. Especially preferred formulations comprise a synergistic combination of a co-solvent and a surfactant and may further include a secondary co-solvent. Among other advantages of contemplated formulations, aprepitant is dissolved at high concentrations and remains dissolved and stable, even over prolonged periods of time.

    Abstract translation: 制备一种水性稳定且即用型的阿瑞匹坦制剂。 特别优选的制剂包括助溶剂和表面活性剂的协同组合,并且还可以包括仲辅助溶剂。 除了预期制剂的其它优点之外,阿瑞匹坦剂以高浓度溶解并保持溶解和稳定,即使在长时间内也是如此。

    BENDAMUSTINE COMPOSITIONS AND METHODS THEREFORE
    10.
    发明申请
    BENDAMUSTINE COMPOSITIONS AND METHODS THEREFORE 审中-公开
    BENDAMUSTINE组合物及其方法

    公开(公告)号:US20130210878A1

    公开(公告)日:2013-08-15

    申请号:US13749443

    申请日:2013-01-24

    CPC classification number: A61K47/02 A61K9/0019 A61K31/4184 A61K47/10

    Abstract: Aqueous Bendamustine formulations with improved stability are disclosed. Especially preferred formulations are low-dose ready-to-use liquid formulations in which Bendamustine is in a non-aqueous vehicle in combination with an aqueous phase that contains significant quantities of chloride.

    Abstract translation: 公开了具有改善的稳定性的苯达莫司汀配方。 特别优选的制剂是低剂量即用型液体制剂,其中苯达莫司汀与含有大量氯化物的水相组合在非水载体中。

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