Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression

Abstract

Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified approach for blend CQA characterisation in a high-shear semi-continuous blender (originally developed for low-shear batch blenders), and combines it with a blend content uniformity model (developed for high-shear continuous blenders) to characterise content uniformity responses of a high-shear semi-continuous blender (Gericke GBM-10-P Mini Blender).Blend content uniformity assessed across process conditions and formulations shows that for a given formulation one set of model parameters can be regressed for all datapoints, allowing insight to be transferred between blender scales and types. This infers that lab-scale low-shear batch blenders can be used to predict the content uniformity response of the high-shear semi-continuous blender, minimising materials consumption and experimental burden.