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    ABUSE RESISTANT PHARMACEUTICAL COMPOSITIONS
    61.
    发明申请
    ABUSE RESISTANT PHARMACEUTICAL COMPOSITIONS 有权

    公开(公告)号：US20160074385A1

    公开(公告)日：2016-03-17

    申请号：US14851019

    申请日：2015-09-11

    Applicant: ALKERMES PHARMA IRELAND LIMITED

    Inventor： Gurvinder S. Rekhi ,  Richard Sidwell

    IPC: A61K31/485

    CPC classification number: A61K31/485 ,  A61K9/0053 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/1676 ,  A61K9/48 ,  A61K9/5078 ,  A61K9/5084 ,  A61K47/10

    Abstract: The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.

    TIMED, PULSATILE RELEASE SYSTEMS
    63.
    发明申请
    TIMED, PULSATILE RELEASE SYSTEMS 有权
    TIMED，PULSATILE RELEASE系统

    公开(公告)号：US20160038431A1

    公开(公告)日：2016-02-11

    申请号：US14885654

    申请日：2015-10-16

    Applicant: ADARE PHARMACEUTICALS, INC.

    Inventor： Gopi M. Venkatesh

    IPC: A61K9/50 ,  A61K9/16 ,  A61K31/426

    CPC classification number: A61K9/5073 ,  A61K9/0053 ,  A61K9/1676 ,  A61K9/2081 ,  A61K9/4808 ,  A61K9/5042 ,  A61K9/5047 ,  A61K9/5078 ,  A61K9/5084 ,  A61K9/5089 ,  A61K31/426

    Abstract: A unit multiparticulate dosage form for delivering one or more basic, active pharmaceutical ingredients into the body in need of such medications to achieve target PK (pharmocokinetics) profiles is described. The dosage form comprises one or more multicoated drug particles (beads, pellets, mini-/micro-tablets) having a barrier coating and a lag-time coating. Each Timed Pulsatile Release (TPR) bead population exhibits pre-determined lag-time followed by differing release characteristics. The composition and thickness of the barrier coating, composition and thickness of the lag-time coating, ratio of IR beads to one or more TPR bead populations and total dose may be varied depending on the alkalinity, pH-dependent solubility and elimination half-life of the active ingredients to achieve target PK profiles (suitable for a once or twice daily dosing regimen) in patients in need of such medications.

    Abstract translation: 描述了用于将一种或多种碱性活性药物成分输送到需要这种药物以实现目标PK（药物动力学）分布的身体中的单位多颗粒剂型。 剂型包括具有阻隔涂层和滞后时间涂层的一种或多种多药物颗粒（珠粒，丸剂，微型/微型片剂）。 每个定时脉冲释放（TPR）珠群体显示预定的滞后时间，随后是不同的释放特征。 阻隔涂层的组成和厚度，滞后时间涂层的组成和厚度，IR珠粒与一个或多个TPR珠粒群的比例和总剂量可以根据碱度，pH依赖性溶解度和消除半衰期而变化 的活性成分，以实现需要这种药物的患者的目标PK谱（适合每天一次或两次一次给药方案）。

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