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    Amylin agonist pharmaceutical compositions containing insulin
    1.
    发明授权
    Amylin agonist pharmaceutical compositions containing insulin 失效
    胰岛淀粉样多肽激动剂含有胰岛素的药物组合物

    公开(公告)号：US6136784A

    公开(公告)日：2000-10-24

    申请号：US005240

    申请日：1998-01-09

    申请人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby ,  Orville Kolterman

    发明人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby ,  Orville Kolterman

    IPC分类号： A61K38/22 ,  A61K38/28 ,  A61K38/00

    CPC分类号： A61K38/22 ,  A61K38/28 ,  Y10S514/866

    摘要： The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.

    摘要翻译： 本发明涉及容器中的药物制剂，例如小瓶，预填充的药筒，预充式注射器或一次性笔，其包含在水系统中约0.01至约0.5％（w / v）的胰岛淀​​粉样多肽激动剂，优选普兰林肽 以及约0.02至约0.5％（w / v）的乙酸盐，磷酸盐，柠檬酸盐或谷氨酸盐缓冲液至最终组合物的pH为约3.0至约6.0，以及约1.0至10％（w / v） 的碳水化合物或多元醇增稠剂; 和任选的约0.005至1.0％（w / v）的选自间甲酚，苯甲醇，对羟基苯甲酸酯和苯酚的防腐剂。 这些制剂在冷冻或室温条件下保存时保持稳定性。 这样的制剂可以在相同的注射器中进一步与胰岛素组合以给予患者。