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    A DELAYED RELEASE DRUG FORMULATION
    5.
    发明公开
    A DELAYED RELEASE DRUG FORMULATION 审中-公开
    延迟释放药物制剂

    公开(公告)号：EP3278792A1

    公开(公告)日：2018-02-07

    申请号：EP17188821.7

    申请日：2013-04-29

    申请人： Tillotts Pharma AG

    发明人： BRAVO GONZÁLEZ, Roberto Carlos ,  BUSER, Thomas ,  GOUTTE, Frédéric Jean-Claude ,  BASIT, Abdul, Waseh ,  VARUM, Felipe, José, Oliveria ,  FREIRE, Ana, Cristina

    IPC分类号： A61K9/00 ,  A61K9/28 ,  A61K31/606 ,  A61K47/32 ,  A61K47/36 ,  A61K9/20 ,  A61K31/196 ,  A61K31/616

    CPC分类号： A61K9/2886 ,  A61K9/0053 ,  A61K9/2013 ,  A61K9/2054 ,  A61K9/284 ,  A61K9/2846 ,  A61K9/2853 ,  A61K9/286 ,  A61K9/2866 ,  A61K9/288 ,  A61K9/2893 ,  A61K31/196 ,  A61K31/606 ,  A61K31/616 ,  A61K47/32 ,  A61K47/36 ,  A61K47/38

    摘要： Delayed release of a drug to the colon is achieved from a delayed release formulation comprising a core and a coating for the core. The core comprises a drug and the coating comprises an outer layer and at least one layer between the core and the outer layer selected from the group consisting of an isolation layer and an inner layer. The outer layer comprises a mixture of a first polymeric material which is susceptible to attack by colonic bacteria, and a second polymeric material which has a pH threshold at about pH 6 or above. The inner layer comprises a third polymeric material which is a non-ionic polymer soluble in intestinal fluid or gastrointestinal fluid, and at least one of a buffer agent and a base. The isolation layer comprises a non-ionic polymer which is soluble in intestinal fluid or gastrointestinal fluid. The outer is applied directly to the inner layer or the isolation layer using a coating preparation formed by combining the first polymeric material in an aqueous medium with a second polymeric material in an organic medium. Advantages of formulations according to the present invention include accelerated release of the drug when exposed to colonic conditions and reduction or elimination of a food and/or alcohol effect on drug release after administration.

    摘要翻译： 药物向结肠的延迟释放是由包含核心和核心包衣的延迟释放制剂实现的。 芯包含药物并且涂层包含外层以及在芯和外层之间的至少一个选自隔离层和内层的层。 外层包含容易受结肠细菌侵袭的第一种聚合物材料和在约pH6或以上具有pH阈值的第二种聚合物材料的混合物。 内层包含第三聚合物材料，其是可溶于肠液或胃肠液的非离子聚合物，以及缓冲剂和碱中的至少一种。 隔离层包含可溶于肠液或胃肠液的非离子聚合物。 使用通过将含水介质中的第一聚合物材料与有机介质中的第二聚合物材料组合而形成的涂层制剂将外层直接施加至内层或隔离层。 根据本发明的制剂的优点包括当暴露于结肠条件时加速释放药物并减少或消除给药后药物释放的食物和/或酒精效应。

    MONOLITHIC TABLETS BASED ON CARBOXYL POLYMERIC COMPLEXES FOR CONTROLLED DRUG RELEASE
    8.
    发明公开
    MONOLITHIC TABLETS BASED ON CARBOXYL POLYMERIC COMPLEXES FOR CONTROLLED DRUG RELEASE 审中-公开
    基于羧基聚合物复合解放剂单片片剂

    公开(公告)号：EP3137062A1

    公开(公告)日：2017-03-08

    申请号：EP15786695.5

    申请日：2015-04-28

    申请人： Matripharm Inc.

    发明人： MATEESCU, Mircea-Alexandru ,  LE, Tien Canh

    IPC分类号： A61K9/26 ,  A61K47/04 ,  A61K47/36 ,  A61P29/00 ,  A61P3/10

    CPC分类号： A61K9/2054 ,  A61K9/2059 ,  A61K31/155 ,  A61K31/606 ,  A61K47/36

    摘要： The present document describes a dosage form for delivery of an active ingredient comprising: a first carboxylated polymer having carboxyl groups, having a degree of substitution of at least 0.2, a molecular weight of at least 200 kDa, and at least 30% of said carboxyl groups being complexed with a divalent cation; alone or in a co-complex with at least one of a) a control release polymer chosen from an insoluble polymer or a polymer having a reduced water solubility at 30° C., and a soluble polymer; and b) a second carboxylated polymer having carboxyl groups complexed with a divalent cation. The document also describes processes of making a carboxylated polymer having carboxyl groups, having a degree of substitution of at least 0.2, a molecular weight of at least 200 kDa, and at least 30% of said carboxyl groups being complexed with a divalent cation, and an inclusion complex, a co-complex, or both comprising the same.

    摘要翻译： 本文献描述了一种剂型，其用于递送活性成分，其包括：具有第一羧化聚合物的羧基基团，具有一个度至少为0.2，分子量至少为200kDa的的取代，以及所述羧基的至少30％的 基团络合与二价阳离子; 单独使用或在共络合物的至少一个）从水不溶性聚合物或具有在30℃下具有降低了水溶解性，和可溶性聚合物的聚合物中选择的控制释放聚合物; 和b）具有与二价阳离子络合的羧基基团的第二羧化聚合物。 所以该文档描述了制备羧化聚合物具有羧基，聚合度至少0.2，至少200 kDa的分子量，并且所述羧基基团的至少30％的取代的与二价阳离子络合的工序，和 在包合物，共复杂，或两者都包括相同。

    PHARMACEUTICAL FORMULATION CONTAINING GLYCOSAMINOGLYCAN
    10.
    发明公开
    PHARMACEUTICAL FORMULATION CONTAINING GLYCOSAMINOGLYCAN 审中-公开
    药物制剂糖胺聚糖

    公开(公告)号：EP2968195A4

    公开(公告)日：2016-07-27

    申请号：EP13877756

    申请日：2013-04-19

    申请人： AIHOL CORP

    发明人： CHANG PAO-HO

    IPC分类号： A61K9/50

    CPC分类号： A61K31/606 ,  A61K9/2081 ,  A61K9/5026 ,  A61K9/5036 ,  A61K9/5078 ,  A61K47/36

    摘要： A pharmaceutical formulation containing a glycosaminoglycan is provided, In this pharmaceutical formulation, a glycosaminoglycan layer surrounding a drug layer is used to improve the treatment efficiency of enteric diseases. According to an embodiment, the pellet above comprises a core, a drug layer surrounding the core, a glycosaminoglycan layer surrounding the drug layer, an isolation layer surrounding the glycosaminoglycan layer, and an enteric coating layer surrounding the isolation layer. Accordingly, the weight ratio of the core, the drug layer, the glycosaminoglycan layer, the isolation layer, and the enteric coating is 100:137-141: 25-29:9-13:60-64, and preferably 100: 139: 27: 11: 62.