发明公开
EP2654720A1 PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING A LOW SOLUBLE PHARMACEUTICALLY ACTIVE INGREDIENT
审中-公开
METHOD FOR生产药物组合物与药物溶解度低的药物
- 专利标题： PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING A LOW SOLUBLE PHARMACEUTICALLY ACTIVE INGREDIENT
- 专利标题（中）： METHOD FOR生产药物组合物与药物溶解度低的药物
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申请号： EP11804679.6申请日： 2011-12-21
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公开(公告)号： EP2654720A1公开(公告)日： 2013-10-30
- 发明人: STARIC, Rok , SKUBIN, Simon , HOMAR, Miha , MARKUN, Bostjan , BERGLEZ, Sandra , KRALJ, Petra , BOSKOVIC, Marija
- 申请人： LEK Pharmaceuticals d.d.
- 申请人地址： Verovskova 57 1526 Ljubljana SI
- 专利权人： LEK Pharmaceuticals d.d.
- 当前专利权人： LEK Pharmaceuticals d.d.
- 当前专利权人地址： Verovskova 57 1526 Ljubljana SI
- 代理机构： Prüfer & Partner GbR European Patent Attorneys
- 优先权： EP10015940 20101222
- 国际公布： WO2012085071 20120628
- 主分类号： A61K9/107
- IPC分类号： A61K9/107 ; A61K9/16 ; A61K31/397 ; A61K9/20 ; A61P3/06
摘要：
The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing a pharmaceutical composition comprising a pharmaceutically active ingredient (API) that is poorly soluble in water, preferably ezetimibe, a pharmaceutical composition obtained according to said process, to a dosage form comprising said pharmaceutical composition and to the use of said dosage forms for the treatment of hypercholesterolemia. The process comprises the steps of providing a suspension comprising API and excipient(s), subjecting it to a high energy input treatment and processing it by high shear granulation, fluid bed granulation, spray drying or lyophilisation.
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