EP2468258A1 — Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient

USPTO Abstract

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.