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    • 3. 发明申请
    • DELAYED RELEASE COMPOSITIONS OF DULOXETINE
    • 延迟释放DULOXETINE的组合物
    • US20110020439A1
    • 2011-01-27
    • US12934148
    • 2009-03-17
    • Shrenik Annasaheb KoleAshok Kumar SahooMakarand Krishnakumar Avachat
    • Shrenik Annasaheb KoleAshok Kumar SahooMakarand Krishnakumar Avachat
    • A61K31/381A61K9/52A61K9/22A61P25/00A61P25/22A61P25/24B05D5/00
    • A61K31/381A61K9/2072A61K9/2866A61K9/2886A61K9/4808
    • A delayed release dosage form comprising core comprising duloxetine or its pharmaceutically acceptable salts or derivatives thereof, optionally, other pharmaceutically acceptable excipient(s) thereof; intermediate layer; and enteric layer; wherein the dosage form comprises one/more dissolution enhancer(s), wherein the enteric layer comprises one/more enteric polymers other than hydroxypropylmethyl acetate succinate. A process of preparing a delayed release dosage comprising mixing pharmaceutically acceptable excipients with duloxetine or its pharmaceutically acceptable derivatives thereof; granulating the product of previous step compressing the granulate formed in previous step to form core, coating said core with intermediate layer followed by coating with one/more enteric polymers and optional finishing coating. A delayed release dosage form comprising: core comprising duloxetine or its pharmaceutically acceptable derivative thereof, intermediate layer and enteric layer comprising one/more enteric polymers other than hydroxypropylmethyl acetate succinate; wherein dosage form contains one/more dissolution enhancer(s) and has improved dissolution.
    • 延迟释放剂型,其包含核心,其包含度洛西汀或其药学上可接受的盐或衍生物,任选地,其它药学上可接受的赋形剂; 中间层 肠溶层; 其中所述剂型包含一种或多种溶出增强剂,其中所述肠溶层包含除了羟丙基甲基醋酸琥珀酸酯之外的一种/多种肠溶聚合物。 制备延迟释放剂量的方法,包括将药学上可接受的赋形剂与度洛西汀或其药学上可接受的衍生物混合; 造粒前一步骤的产品压缩前一步骤形成的颗粒以形成芯,用中间层涂覆所述芯,然后用一种/多种肠溶聚合物和可选的整理涂层进行包衣。 延迟释放剂型,其包含:包含度洛西汀或其药学上可接受的衍生物的核心,中间层和肠溶层,其包含除羟丙基甲基醋酸琥珀酯之外的一种/多种肠溶聚合物; 其中剂型含有一种/多种溶解增强剂并具有改善的溶解。