PATCH AND METHOD FOR PRODUCING THE SAME
    5.
    发明申请
    PATCH AND METHOD FOR PRODUCING THE SAME 有权
    配对及其制造方法

    公开(公告)号:US20150164862A1

    公开(公告)日:2015-06-18

    申请号:US14417205

    申请日:2013-07-25

    摘要: A method for producing a patch comprising a support layer and an adhesive agent layer comprises: a mixture preparation step of mixing asenapine or a pharmaceutically acceptable salt thereof with sodium acetate whose particle diameter D50 at a cumulative volume of 50% in a particle diameter distribution is 40 to 1000 μm, in such a manner that the sodium acetate and sodium diacetate generated from the sodium acetate have a particle diameter D50 of 10 μm or smaller, thereby obtaining a mixture containing the sodium diacetate and the asenapine or pharmaceutically acceptable salt; and an adhesive-agent-layer formation step of forming the adhesive agent layer comprising the sodium diacetate, the asenapine or pharmaceutically acceptable salt, and a pressure-sensitive adhesive base agent, by using an adhesive agent layer composition obtained by mixing the mixture with the pressure-sensitive adhesive base agent.

    摘要翻译: 制备包含支持层和粘合剂层的贴剂的方法包括:混合制备步骤,其将粒径分布中累积体积为50%的粒径D50与甲酸钠的药学上可接受的盐混合, 40至1000μm,使得由乙酸钠生成的乙酸钠和二乙酸钠的粒径D50为10μm或更小,从而获得含有二乙酸钠和阿替平或其药学上可接受的盐的混合物; 以及通过使用通过将混合物与所述粘合剂层组合物混合而获得的粘合剂层组合物形成包含二乙酸钠,阿替平或其药学上可接受的盐的粘合剂层和粘合剂基剂的粘合剂层形成步骤 压敏胶基剂。

    Patch
    9.
    发明授权
    Patch 有权

    公开(公告)号:US10583121B2

    公开(公告)日:2020-03-10

    申请号:US15454066

    申请日:2017-03-09

    摘要: A patch for administering asenapine includes a support layer, and an adhesive agent layer formed on the support layer and including an adhesive base agent and asenapine and/or a pharmaceutically acceptable salt thereof. The adhesive base agent has a content in a range of 10 to 90% by mass in the adhesive agent layer and includes a natural rubber, polyisobutylene, an alkyl vinyl ether(co)polymer, polyisoprene, polybutadiene, a styrene-butadiene copolymer, a styrene-isoprene copolymer, a styrene-isoprene-styrene block copolymer, or a combination thereof. When a content of the asenapine and/or pharmaceutically acceptable salt thereof in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC2-120 for a period starting from the time when the patch is brought into contact with a skin for 24 hours is 27,000 pg·hr/mL or more, and an AUC2-120 of an asenapine metabolite is 20% or less of the AUC2-120 of the free asenapine.