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    CONTROLLED RELEASE SOLID DOSE FORMS
    2.
    发明公开
    CONTROLLED RELEASE SOLID DOSE FORMS 有权
    控制释放固体剂量形式

    公开(公告)号：EP2714015A1

    公开(公告)日：2014-04-09

    申请号：EP12792447.0

    申请日：2012-05-23

    申请人： FMC Corporation

    发明人： SIEPMANN, Juergen ,  CUPPOK, Yvonne

    IPC分类号： A61K9/48 ,  A61K9/28 ,  A61K47/38 ,  A61K47/48 ,  A61K47/30

    CPC分类号： A61K9/288

    摘要： The present invention is directed to a solid dose form comprising a film coating composition encapsulating a core, wherein: (i) the core comprises an active ingredient comprising at least one of a pharmaceutical, veterinary, or nutraceutical active ingredient; (ii) the film coating composition comprises ethylcellulose and guar gum, wherein the guar gum has an apparent viscosity ≥ 151.0 cps at a shear rate of 50 s
    -1 in a 1% aqueous guar gum solution measured rotationally at 20°C after 1 minute equilibration using a 6 cm acrylic cone (1°) on a cone -plate viscometer wherein the shear is ramped up linearly from 1 to 50 s
    -1 in 25 steps over 29 seconds; (iii) the dose form provides controlled release of the active ingredient; (iv) the guar gum is present in an amount greater than 5 wt% based on the weight of the guar gum and ethylcellulose; and (v) the dose form is ethanol resistant.

    摘要翻译： 本发明涉及包含包封核的薄膜包衣组合物的固体剂型，其中：（i）核包含包含药物活性成分，兽药活性成分或营养制品活性成分中的至少一种的活性成分; （ii）所述薄膜包衣组合物包含乙基纤维素和瓜尔胶，其中瓜尔胶在1分钟后在20℃下旋转测量的1％瓜尔胶水溶液中在50s -1的剪切速率下具有≥151.0cps的表观粘度 在锥板式粘度计上使用6cm丙烯酸锥体（1°）平衡，其中剪切在29秒内以25步骤从1线性增加至50s -1; （iii）剂型提供活性成分的受控释放; （iv）以瓜尔胶和乙基纤维素的重量计，瓜尔胶的存在量大于5重量％; 和（v）剂型是乙醇抗性的。