Extrudate
Löslichkeitsverbesserung
Molekulardisperse Verteilung
Rapid-Screening-Verfahren
Schmelzextrusion
Verwendung von pharmazeutischen Extrudaten in der Arzmeimittelherstellung
Übersichten
Abstract
Usage of Pharmaceutical Extrudates in the Manufacturing of Drug Products
Drugs with poor solubility and/or poor permeability (BCS class II and IV) require new formulation concepts to achieve higher bioavailability and targeted delivery into the upper regions of the intestine. By hot melt extrusion and the selection of suitable polymeric matrix excipients a promising formulation approach has been found. In this approach, by a molecular dispersion of the active substance in the carrier matrix drug formulations with a targeted release kinetics are achieved. The choice of process parameters and the screw design determine the quality of the extrudates. By the use of a rapid screening procedure at Catalent small amounts of active ingredient are sufficient to evaluate the suitability of hot melt extrusion process with regard to processability and quality characteristics of the extrudate.
Korrespondenz:
Dr. Uwe Hanenberg, Catalent Pharma Solutions, Steinbeisstrasse 1–2, 73614 Schorndorf, Germany; e-mail: uwe.hanenberg@catalent.com
Key words
Zusammenfassung
Arzneistoffe mit schlechter Löslichkeit und/oder schlechter Permeabilität (BCS-Klasse II und IV) erfordern neuartige Formulierungskonzepte, um höhere Bioverfügbarkeiten und eine gezielte Abgabe in den oberen Darmbereichen zu erzielen. Mittels Schmelzextrusion und der Wahl geeigneter polymerer
