发明名称 |
PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING A LOW SOLUBLE PHARMACEUTICALLY ACTIVE INGREDIENT |
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. |
申请公布号 |
EP2654720(A1) |
申请公布日期 |
2013.10.30 |
申请号 |
EP20110804679 |
申请日期 |
2011.12.21 |
申请人 |
LEK PHARMACEUTICALS D.D. |
发明人 |
STARIC, ROK;SKUBIN, SIMON;HOMAR, MIHA;MARKUN, BOSTJAN;BERGLEZ, SANDRA;KRALJ, PETRA;BOSKOVIC, MARIJA |
分类号 |
A61K9/107;A61K9/16;A61K9/20;A61K31/397;A61P3/06 |
主分类号 |
A61K9/107 |
代理机构 |
|
代理人 |
|
主权项 |
|
地址 |
|