Method of preparing a granulated pharmaceutical composition comprising simvastatin and/or ezetimibe
申请人:KRKA, tovarna zdravil, d.d., Novo mesto
公开号:EP2368543A1
公开(公告)日:2011-09-28
A method of preparing a granulated pharmaceutical composition by wet granulation, which method comprises: (a) suspending one or more pharmaceutically active ingredients comprising statin or ezetimibe or both statin and ezetimibe in a granulating liquid to form a granulating suspension; (b) optionally subjecting the granulating suspension of step (a) to high pressure homogenisation; (c) adding the granulating suspension of step (a) or (b) to a composition comprising one or more pharmaceutically acceptable inactive ingredients; and (d) granulating the mixture of step (c), as well as pharmaceutical compositions obtained by this process.
一种通过湿法制粒制备颗粒药物组合物的方法,该方法包括(a) 将一种或多种包含他汀或依泽替米贝或他汀和依泽替米贝的药用活性成分悬浮于制粒液中,形成制粒悬浮液;(b) 可选择将步骤(a)的制粒悬浮液进行高压均质;(c) 将步骤(a)或(b)的制粒悬浮液加入包含一种或多种药学上可接受的非活性成分的组合物中;(d) 将步骤(c)的混合物以及通过该工艺获得的药物组合物制粒。