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    • 3. 发明申请
    • HOT-MELT EXTRUDED CONTROLLED RELEASE DOSAGE FORM
    • HOT-MELT EXTREDED CONTROLLED RELEASE剂型
    • WO2011009602A1
    • 2011-01-27
    • PCT/EP2010/004459
    • 2010-07-21
    • GRÜNENTHAL GMBHBARNSCHEID, LutzGALIA, Eric
    • BARNSCHEID, LutzGALIA, Eric
    • A61K9/20A61K31/137
    • A61K9/2072A61K9/2031A61K9/2054A61K9/2095A61K31/137
    • The invention relates to a hot-melt extruded pharmaceutical dosage form with controlled release of a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C), the dosage form exhibiting a breaking strength of at least 300 N and having an oblong shape comprising a longitudinal direction of extension, a transversal direction of extension orthogonal to the longitudinal direction of extension, a front side, an opposite back side and a circumferential rim between said front and back side; wherein the core of the pharmaceutical dosage form has a morphological orientation caused by hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the dosage form; and/or - the release per area of the pharmacologically active ingredient (A) through the front side and the opposite back side is faster than the release through the circumferential rim.
    • 本发明涉及一种具有控制释放包含聚合物(C)的基质中的药理学活性成分(A)的热熔挤出药物剂型,所述剂型具有至少300N的断裂强度并且具有长方形 形状,其包括纵向延伸方向,垂直于所述纵向延伸方向的横向方向,所述前侧和后侧之间的前侧,相对的后侧和周向边缘; 其中所述药物剂型的核心具有由与所述剂型的延伸长度方向基本正交的热熔融挤出引起的形态取向; 和/或 - 通过前侧和相对的后侧的药理学活性成分(A)的每个面积的释放比通过周缘的释放快。