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    • 52. 发明公开
    • A CONTROLLED-RELEASED OSMOTIC PUMP TABLET WITH LUBRICATING LAYER AND THE PREPARATION THEREOF
    • 具有控释和滑动层和生产渗透泵片
    • EP2380562A1
    • 2011-10-26
    • EP09832823.0
    • 2009-12-16
    • Beijing Kexin Bicheng Biomedical Technology Development Co., Ltd.
    • JIANG, HaisongWANG, Jingang
    • A61K9/22A61K9/28A61K31/4422A61P9/10
    • A61K9/0004A61K31/4422
    • The invention relates to the field of pharmaceutical preparation, in particular to a bilayer osmotic pump controlled-release tablet preparation and a preparation method thereof. Said bilayer osmotic pump controlled-release tablet comprises a conventional tablet core, release control layer(s) and drug release hole(s), wherein one or more lubricating layer structure(s) is/are disposed between the tablet core and the release control layer(s). The lubricating layer(s) is/are present in an amount of from 0.5% to 6% based on the weight of the bilayer tablet core. The lubricating layer(s) rapidly hydrates once in contact with water to form the favorable lubricating liquor between the tablet core and the release control layer(s), hence reducing the shear force between the drug-containing layer(s) and the release control layer(s), whereby the drug-containing layer(s) is/are pushed out completely by the propellant layer(s) to reach a drug release percent of nearly 100%. This solves the problem of the incomplete drug release due to the dead angle generated by the drug-containing layer of a conventional bilayer osmotic pump controlled-release tablet during the release procedure. This technique ensures the superior bioavailability of the bilayer osmotic pump controlled-release tablet as prepared.
    • 本发明涉及药物制剂的领域中,特别是双层渗透泵控释片制剂及其制备方法。 所述双层渗透泵控释片包括常规的片剂核心,释放控制层(一个或多个)和药物释放孔(一个或多个),worin一种或多种润滑层结构(S)是被所述片芯和释放控制之间设置/ 层(S)。 润滑层(多个)/存在于基于所述双层片剂芯的重量的从0.5%至6%的量存在。 润滑层(一个或多个)在与水接触时快速水合一次以形成片芯和释放控制层(一个或多个)之间的良好的润滑液,因此减少了含有药物的层(S)和释放控制之间的剪切力 层(S),由此,药物含有层(多个)/被完全推出由推进剂层(一个或多个)电话,以达到接近100%的药物释放百分比。 这解决了问题的不完全的药物释放由于释放过程期间由常规的双层渗透泵控释片剂的药物含有层中产生的死角。 该技术保证了双层渗透泵控释片剂的生物利用度优异作为制备。