Comparison of single pot and multiphase granulation. Part 1: Effect of the high shear granulator on granule properties according to the drug substance and its concentration

Abstract

Pharmaceutical granulations are usually developed with regard to a specific manufacturing process but switching from one piece of equipment to another can be necessary to comply with the available industrial equipment. Investigations were undertaken on formulations differing in the drug substance and in its concentration. Our aim was to highlight the effect of the granulation process on granules manufactured in a pilot scale Moritz Turbosphere TS50 or in Fielder PMA 65 and dried in a Glatt GPCG1 fluid bed dryer. The granulation process and formulation parameters showed a significant impact on granule size distribution, behaviour under pressure, and on tablet mechanical properties and dissolution kinetics.