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    PATCH AND METHOD FOR PRODUCING THE SAME
    6.
    发明申请
    PATCH AND METHOD FOR PRODUCING THE SAME 审中-公开

    公开(公告)号：US20190105391A1

    公开(公告)日：2019-04-11

    申请号：US16209084

    申请日：2018-12-04

    Applicant: HISAMITSU PHARMACEUTICAL CO., INC.

    Inventor： Masayuki Suzuki ,  Hiroaki Okutsu ,  Takashi Yasukochi ,  Yasunori Takada

    IPC: A61K47/12 ,  A61K31/407 ,  A61K31/55 ,  A61K47/10 ,  A61M37/00 ,  A61K9/70 ,  A61K47/14 ,  A61K47/06

    Abstract: A method for producing a patch including a support layer, and an adhesive agent layer formed on the support layer and including sodium diacetate, a pressure-sensitive adhesive base agent, and asenapine and/or a pharmaceutically acceptable salt thereof. The sodium diacetate is generated from sodium acetate in the presence of the asenapine and/or salt thereof, a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is in range of 3.0 to 20 mg, and when a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is 6.4 mg and the patch is in contact with skin for 24 hours, Cmax of free asenapine is in range of 0.5 to 6.0 ng/mL and tmax of free asenapine is in range of 8 to 28 hr.

    Patch and method for producing the same
    7.
    发明授权
    Patch and method for producing the same 有权
    补片及其制作方法

    公开(公告)号：US09511051B2

    公开(公告)日：2016-12-06

    申请号：US14417205

    申请日：2013-07-25

    Applicant: HISAMITSU PHARMACEUTICAL CO., INC.

    Inventor： Masayuki Suzuki ,  Hiroaki Okutsu ,  Takashi Yasukochi ,  Yasunori Takada

    IPC: A61K31/407 ,  A61K47/06 ,  A61K9/70 ,  A61K47/14 ,  A61K47/12

    CPC classification number: A61K47/12 ,  A61K9/7038 ,  A61K9/7046 ,  A61K9/7053 ,  A61K9/7061 ,  A61K9/7069 ,  A61K31/407 ,  A61K31/55 ,  A61K47/06 ,  A61K47/10 ,  A61K47/14 ,  A61M37/00

    Abstract: 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.

    Abstract translation: 在包含支撑层和粘合剂层的贴剂中，粘合剂层包含游离的阿替那非，马来酸碱金属盐和橡胶基粘合剂。

    Patch
    10.
    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

    Applicant: HISAMITSU PHARMACEUTICAL CO., INC.

    Inventor： Masayuki Suzuki ,  Hiroaki Okutsu ,  Takashi Yasukochi ,  Yasunori Takada

    IPC: A61K31/407 ,  A61K47/10 ,  A61K47/06 ,  A61K9/70 ,  A61K47/12 ,  A61K47/14 ,  A61M37/00 ,  A61K31/55

    Abstract: 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.

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