FORMULATIONS AND METHODS FOR LYOPHILIZATION AND LYOPHILATES PROVIDED THEREBY
    8.
    发明申请
    FORMULATIONS AND METHODS FOR LYOPHILIZATION AND LYOPHILATES PROVIDED THEREBY 审中-公开
    柠檬酸和柠檬酸提供的配方和方法

    公开(公告)号:US20150141516A1

    公开(公告)日:2015-05-21

    申请号:US14508488

    申请日:2014-10-07

    Inventor: Sven Jacobson

    Abstract: The present invention provides compositions, methods for lyophilizing compounds and making pharmaceutical compositions, and kits providing solutions and lyophilized formulations of compounds. The compositions, methods, and kits are particularly useful in pharmaceutical applications involving therapeutic agents that have low solubility at low pH and medium pH values. Certain embodiments provide methods for lyophilizing compounds in liquid solutions, which include the steps of: a) preparing aqueous solutions of a compound of interest in the absence of buffer; b) adjusting the pH to high values of pH in order to increase the solubility of the compound of interest; and c) freeze-drying the solution to provide a lyophilized solid composition. Aqueous solutions including buffer are also disclosed. Lyophilized formulations, including micronized and non-micronized powders, are provided.

    Abstract translation: 本发明提供组合物,冻干化合物和制备药物组合物的方法,以及提供化合物溶液和冻干制剂的试剂盒。 组合物,方法和试剂盒在涉及在低pH值和中等pH值下具有低溶解度的治疗剂的药物应用中特别有用。 某些实施方案提供了在液体溶液中冻干化合物的方法,其包括以下步骤:a)在不存在缓冲液的情况下制备目的化合物的水溶液; b)将pH调节至高的pH值,以增加目标化合物的溶解度; 和c)冷冻干燥该溶液以提供冻干固体组合物。 还公开了包括缓冲液的水溶液。 提供冻干制剂,包括微粉化和非微粉化粉末。

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