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    PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING EZETIMIBE
    5.
    发明公开
    PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING EZETIMIBE 审中-公开
    VERFAHREN ZUR HERSTELLUNG EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG MIT EZETIMIB

    公开(公告)号：EP2393482A2

    公开(公告)日：2011-12-14

    申请号：EP10702494.5

    申请日：2010-02-05

    申请人： LEK Pharmaceuticals d.d.

    发明人： KERC, Janez ,  HOMAR, Miha ,  JURKOVIC, Polona

    IPC分类号： A61K9/14 ,  A61K9/20 ,  A61K31/366 ,  A61K31/397

    CPC分类号： A61K9/145 ,  A61K9/2018 ,  A61K9/2095

    摘要： The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing ezetimibe, comprising the steps of: a) providing a composition comprising ezetimibe, b) sieving a composition comprising a composition of step (a), c) shear mixing of the composition after step (b), preferably the mixing of the composition is carried out by high shear mixing, d) formulation into a dosage form. The present invention also relates to dosage forms containing ezetimibe and ezetimibe and simvastatin, which have been prepared according to the process according to the invention.

    摘要翻译： 本发明属于制药工业领域，涉及一种制备含有依泽替米贝的剂型的方法，包括以下步骤：a）提供包含依泽替米贝的组合物，b）筛分包含步骤（a），c ）组合物在步骤（b）之后混合，优选组合物的混合通过高剪切混合进行，d）配制成剂型。 本发明还涉及根据本发明的方法制备的依泽替米贝，依泽替米贝和辛伐他汀的剂型。

    PHARMACEUTICAL COMPOSITION COMPRISING EZETIMIBE AND SIMVASTATIN
    6.
    发明公开
    PHARMACEUTICAL COMPOSITION COMPRISING EZETIMIBE AND SIMVASTATIN 有权
    药物组合物辛伐他汀依折麦布

    公开(公告)号：EP2370061A2

    公开(公告)日：2011-10-05

    申请号：EP09760531.5

    申请日：2009-11-30

    申请人： LEK Pharmaceuticals d.d.

    发明人： HOMAR, Miha ,  BURJAK, Mateja ,  HUSU-KOVACEVIC, Breda ,  KERC, Janez

    IPC分类号： A61K9/20

    CPC分类号： A61K9/2086 ,  A61K9/2018 ,  A61K31/366 ,  A61K31/397 ,  A61K2300/00

    摘要： The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing simvastatin and ezetimibe, comprising the steps of providing a first composition containing simvastatin, providing a second composition containing ezetimibe, and forming a dosage form comprising at least two separate compartments, wherein one compartment is formed using either the first or the second composition and another compartment is formed using the other composition. The present invention also relates to a process for preparing dosage forms containing simvastatin and ezetimibe, wherein the process involves a direct compression step. Furthermore, the present invention belongs to a dosage form obtained by this process, comprising at least two separate compartments, wherein one compartment contains simvastatin and one compartment contains ezetimibe. Finally, the present invention relates to a combination dosage form comprising a combination of simvastatin and ezetimibe present in two separate compartments of the dosage form.

    HOT-MELT MICROPELLETS
    10.
    发明公开
    HOT-MELT MICROPELLETS 无效
    热熔微颗粒

    公开(公告)号：EP2136792A1

    公开(公告)日：2009-12-30

    申请号：EP08717955.2

    申请日：2008-03-18

    申请人： Lek Pharmaceuticals D.D. ,  Dreu, Rok

    发明人： DREU, Rok ,  HOMAR, Miha ,  BURJAK, Mateja ,  KERC, Janez ,  SRCIC, Stanko

    IPC分类号： A61K9/16 ,  A61K31/192

    CPC分类号： A61K9/1641 ,  A61K9/1694 ,  A61K31/192

    摘要： The present invention provides a method of making solid micropellets of which at least 75% by weight have a diameter less than 500 μm comprising (i) melting one or more binders; and (ii) combining the one or more binders melted in step (i) with a pharmaceutically active ingredient to form solid micropellets. Solid micropellets obtainable by this method are also provided. The invention has particular utility for improving the solubility of poorly water-soluble pharmaceutically active ingredients.