Mapping key process parameters to the performance of a continuous dry powder blender in a continuous direct compression system

Abstract

This work aims to expand the typical raw material attributes that can successfully be processed on a continuous direct compression line with a particular focus on the continuous dry powder blender. Three grades of Acetaminophen were investigated as model active pharmaceutical ingredients and chosen to span a broad range of material attributes wider than what would normally be considered for a direct compression process.An experimental design was set-up for each grade of Acetaminophen to investigate the effect of throughput, impeller speed and impeller configuration on the critical process responses and attributes. The strain experienced by the in-process material was found critical to improve content uniformity. The impeller speed and design can be optimised at a given throughput to obtain a strain which would deliver the required content homogeneity. The content uniformity of the final tablets can be modelled as a function of the strain using an exponential decay model.