Application Note: Freeman Technology – Optimising continuous wet granulation

Freeman Technology and GEA Pharma Systems have conducted a study to investigate the feasibility of predicting critical quality attributes (CQA) of tablets from intermediate granule properties…

Wet granulation is routinely used in pharmaceutical manufacturing to convert fine and challenging powder blends into homogeneous granules that are then dried, milled and lubricated, before being fed through the tablet press, hopefully to form tablets of the desired properties. The aim therefore is to generate granules that flow consistently and, more importantly, produce high quality tablets. Whilst the granules are not the end product, it is known that their properties have a significant effect on the attributes of the tablet.

Freeman Technology and GEA Pharma Systems have conducted a study to investigate the feasibility of predicting critical quality attributes (CQA) of tablets from intermediate granule properties. This research has revealed a robust correlation between tablet hardness and the Basic Flowability Energy (BFE – a dynamic powder property) of the granules used to produce the tablet. The work demonstrates how BFE measurements have considerable potential to develop and optimise wet granulation processes and enhance product development and process control…