RAPIDLY DISINTEGRATING ORAL FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR
    4.
    发明公开
    RAPIDLY DISINTEGRATING ORAL FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR 有权
    FAST DECAY END口服药物制备伐地考昔含

    公开(公告)号:EP1309315A2

    公开(公告)日:2003-05-14

    申请号:EP01964122.4

    申请日:2001-08-17

    CPC分类号: A61K9/0056

    摘要: A molded article such as a tablet is provided for administration to an oral cavity of a subject to treat or prevent a cyclooxygenase-2 mediated condition, disorder or disease. The molded article comprises a moldable blend of a therapeutically effective amount of a selective cyclooxygenase-2 inhibitory drug with a pharmaceutically acceptable excipient carrier system consisting predominantly of one or more carbohydrates, wherein ingredients and amounts thereof in the molded article and a process for preparing the molded article are selected such that the molded article exhibits rapid disintegration in the oral cavity, and wherein the moldable blend is prepared by a process step not requiring wet granulation.

    ORAL FAST-MELT DOSAGE FORM OF A CYCLOOXYGENASE-2 INHIBITOR
    7.
    发明公开
    ORAL FAST-MELT DOSAGE FORM OF A CYCLOOXYGENASE-2 INHIBITOR 审中-公开
    环氧合酶-2抑制剂的口服快速熔融剂型

    公开(公告)号:EP1309316A2

    公开(公告)日:2003-05-14

    申请号:EP01965987.9

    申请日:2001-08-17

    摘要: A process is provided for preparing an oral fast-melt composition of a selective cyclooxygenase-2 inhibitory drug comprising (a) a step of wet granulating the selective cycloorxygenase-2 inhibitory drug together with a binding agent selected from grums, polypetpides, natural and modified starches, cellulosic materials, alginic acid and salts thereof, polyethylene glycol, polyvinylpyrrolidone, polymethacrylates, silicate salts and bentonites, and (b) a step of blending with the drug a saccharide of low moldability, wherein the above steps (a) and (b) occur in any order or simultaneously to result in formation of granules. Optionally the process further comprises (c) a step of blending the granules with at least one of a lubricant, a sweetening agent and a flavoring agent to form a tableting blend, and (d) a step of compressing the tableting blend to form oral fast-melt tablets. Also provided is a composition prepared by such a process.

    摘要翻译: 本发明提供了制备选择性环加氧酶-2抑制药的口服快速熔融组合物的方法,该方法包括(a)将选择性环氧合酶-2抑制药与选自粗菌,多肽,天然和修饰的结合剂一起湿法制粒的步骤 (b)与药物混合低成型性糖类的步骤,其中上述步骤(a)和(b)包括以下组分: )以任何顺序发生或同时发生以形成颗粒。 任选地,该方法进一步包括(c)将颗粒与润滑剂,甜味剂和调味剂中的至少一种共混以形成压片混合物的步骤,和(d)压制压片混合物以形成口服快速 融化片剂。 还提供了通过这种方法制备的组合物。