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    • 4. 发明申请
    • STABLE PHARMACEUTICAL FORMULATIONS OF ZONISAMIDE AND METHODS FOR THEIR MANUFACTURE
    • ZONISAMIDE的稳定的药物制剂及其制造方法
    • WO2006078948A3
    • 2007-01-25
    • PCT/US2006002103
    • 2006-01-20
    • TEVA PHARMATEVA PHARMAHRAKOVSKY JULIATENENGAUZER RUTH
    • HRAKOVSKY JULIATENENGAUZER RUTH
    • A61K9/16A61K9/14A61K31/423
    • A61K9/1635A61K9/1611A61K9/1617A61K9/1623A61K9/1652A61K9/485A61K9/4858A61K9/4866A61K31/423
    • One of the embodiments of the present invention is directed toward a process for preparing a stable zonisamide pharmaceutical composition, comprising subjecting zonisamide to wet granulation with a granulation liquid to form a granulated mixture as the stable zonisamide pharmaceutical composition, wherein the granulation liquid is selected from purified water, alcohol and mixtures thereof. The stable zonisamide pharmaceutical composition can be used to fill capsule shells to prepare stable zonisamide capsules. Another embodiment of the invention concerns a for preparing a stable zonisamide pharmaceutical capsule, comprising (i) forming an intimate mixture with zonisamide powder and an effective amount of at least one pharmaceutically acceptable excipient by compressing, co-milling, co-micronization and/or co-compaction of the components, or subjecting the components to a similarly intensive process; and (ii) filling capsule shells with the intimate mixture to obtain the stable zonisamide pharmaceutical capsule.
    • 本发明的一个实施方案涉及用于制备稳定的唑尼沙胺药物组合物的方法,其包括用造粒液体对唑尼沙胺进行湿法制粒以形成作为稳定的唑尼拉唑药物组合物的粒化混合物,其中制粒液体选自 纯化水,酒精及其混合物。 稳定的唑尼沙胺药物组合物可用于填充胶囊壳以制备稳定的唑尼沙胺胶囊。 本发明的另一个实施方案涉及用于制备稳定的唑尼沙胺药物胶囊的方法,该方法包括(i)通过压制,共研磨,共微粉化和/或与共溶化的粉末形成与唑尼沙胺粉末和有效量的至少一种药学上可接受的赋形剂的紧密混合物 共同压实部件,或使部件经受类似的密集过程; 和(ii)用紧密混合物填充胶囊壳以获得稳定的唑尼沙胺药物胶囊。
    • 5. 发明申请
    • STABLE PHARMACEUTICAL FORMULATIONS OF ZONISAMIDE AND METHODS FOR THEIR MANUFACTURE
    • 噻菌胺的稳定药用配方及其制造方法
    • WO2006078948B1
    • 2007-03-01
    • PCT/US2006002103
    • 2006-01-20
    • TEVA PHARMATEVA PHARMAHRAKOVSKY JULIATENENGAUZER RUTH
    • HRAKOVSKY JULIATENENGAUZER RUTH
    • A61K9/16A61K9/14A61K31/423
    • A61K9/1635A61K9/1611A61K9/1617A61K9/1623A61K9/1652A61K9/485A61K9/4858A61K9/4866A61K31/423
    • One of the embodiments of the present invention is directed toward a process for preparing a stable zonisamide pharmaceutical composition, comprising subjecting zonisamide to wet granulation with a granulation liquid to form a granulated mixture as the stable zonisamide pharmaceutical composition, wherein the granulation liquid is selected from purified water, alcohol and mixtures thereof. The stable zonisamide pharmaceutical composition can be used to fill capsule shells to prepare stable zonisamide capsules. Another embodiment of the invention concerns a for preparing a stable zonisamide pharmaceutical capsule, comprising (i) forming an intimate mixture with zonisamide powder and an effective amount of at least one pharmaceutically acceptable excipient by compressing, co-milling, co-micronization and/or co-compaction of the components, or subjecting the components to a similarly intensive process; and (ii) filling capsule shells with the intimate mixture to obtain the stable zonisamide pharmaceutical capsule.
    • 本发明的一个实施方案涉及一种制备稳定的唑尼沙胺药物组合物的方法,其包括使唑胺与造粒液进行湿法制粒以形成作为稳定唑尼沙胺药物组合物的造粒混合物,其中造粒液体选自 纯化水,醇及其混合物。 稳定的唑尼沙胺药物组合物可用于填充胶囊壳以制备稳定的唑尼沙胺胶囊。 本发明的另一个实施方案涉及制备稳定的唑尼沙胺药物胶囊,其包括(i)通过压缩,共研磨,共微粉化和/或形成与zonisamide粉末和有效量的至少一种药学上可接受的赋形剂形成紧密混合物 组分的共同压实,或使组分经历类似的密集过程; 和(ii)用紧密混合物填充胶囊壳以获得稳定的唑尼沙胺药物胶囊。