PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING A LOW SOLUBLE PHARMACEUTICALLY ACTIVE INGREDIENT

PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION COMPRISING A LOW SOLUBLE PHARMACEUTICALLY ACTIVE INGREDIENT

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 sa...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: MARKUN, BOSTJAN, KRALJ, PETRA, BERGLEZ, SANDRA, STARIC, ROK, BOSKOVIC, MARIJA, SKUBIN, SIMON, HOMAR, MIHA
Format: Patent
Sprache:eng ; fre ; ger
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung: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.