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    PHARMACEUTICAL COMPOSITION COMPRISING IBRUTINIB
    6.
    发明公开
    PHARMACEUTICAL COMPOSITION COMPRISING IBRUTINIB 审中-公开

    公开(公告)号：EP3669867A1

    公开(公告)日：2020-06-24

    申请号：EP18215288.4

    申请日：2018-12-21

    申请人： Synthon B.V.

    发明人： The designation of the inventor has not yet been filed

    IPC分类号： A61K9/28 ,  A61K9/50 ,  A61K47/38 ,  A61K31/519 ,  A61P35/00

    摘要： The present invention relates to a tablet composition comprising ibrutinib and one or more pharmaceutically acceptable excipients, characterized in that:
    • ibrutinib is form C, having characteristic peaks in the X-ray powder diffraction pattern at the following 2 theta (± 0.2) angles: 6.9°, 18.2°, 19.2°, 19.6° and 23.0°, measured using a Cu Kα radiation, and
    • the composition is free of surfactant, and
    • the composition exhibits a dissolution rate of at least 65% in 20 minutes when tested in 900 ml 0.01 N hydrochloric acid pH 2.0 (+ 1 % Tween 20) at 37°C, 75 rpm and/or in 900 ml phosphate buffer pH 6.8 (+3% Tween 20) at 37°C, 75 rpm in a USP apparatus II.
    The invention further relates to the use of said composition as a medicament, particularly in the treatment of chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and Waldenström's macroglobulinaemia (WM).