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    Multi-particulate form of medicament, comprising at least two differently coated forms of pellet
    18.
    发明授权
    Multi-particulate form of medicament, comprising at least two differently coated forms of pellet 有权
    多颗粒形式的药物，包含至少两种不同的包衣形式的丸剂

    公开(公告)号：US07438929B2

    公开(公告)日：2008-10-21

    申请号：US10949323

    申请日：2004-09-27

    申请人： Thomas Beckert ,  Hans-Ulrich Petereit ,  Jennifer Dressman ,  Markus Rudolph

    发明人： Thomas Beckert ,  Hans-Ulrich Petereit ,  Jennifer Dressman ,  Markus Rudolph

    IPC分类号： A61K9/52 ,  A61K9/14

    CPC分类号： A61K31/58 ,  A61K9/2081 ,  A61K9/5026 ,  A61K9/5073 ,  A61K9/5084 ,  A61K31/573 ,  A61K31/606 ,  A61K31/635

    摘要： The invention relates to a multiparticulate drug form suitable for uniform release of an active pharmaceutical ingredient in the small intestine and in the large intestine, comprising at least two forms of pellets A and B which comprise an active pharmaceutical ingredient in the core and have different polymer coatings which determine the release of the active ingredient at different pH values, characterized in that pellet form A is provided with an inner polymer coating which enables continuous release of active ingredient, and has an outer enteric coating which rapidly dissolves above about pH 5.5, and pellet form B is provided with a polymer coating which, in the USP release test, releases less than 20% of the active ingredient at pH 6.8 in 6 hours and releases more than 50% of the active ingredient at pH 7.2 in 6 hours. The invention additionally relates to a process for producing the multiparticulate drug form and to the use of pellet forms A and B for producing the drug form.

    摘要翻译： 本发明涉及适于在小肠和大肠中均匀释放活性药物成分的多颗粒药物形式，其包含至少两种形式的颗粒A和B，其包含芯中的活性药物成分并具有不同的聚合物 确定在不同pH值下释放活性成分的涂层，其特征在于，颗粒形式A具有能够连续释放活性成分的内部聚合物涂层，并且具有快速溶解在约pH 5.5以上的外部肠溶衣，以及 颗粒形式B具有聚合物涂层，其在USP释放试验中在6小时内在pH 6.8下释放少于20％的活性成分，并在6小时内在pH 7.2下释放超过50％的活性成分。 本发明还涉及生产多颗粒药物形式的方法以及用于制备药物形式的颗粒形式A和B的用途。