Analysis of the Influence of Process and Formulation Properties on the Drying Behavior of Pharmaceutical Granules in a Semi-Continuous Fluid Bed Drying System

Abstract

In the last decade, twin-screw wet granulation became an essential technology for continuous pharmaceutical tablet production. Consequently, interest in (semi-)continuous fluidized bed drying systems as a subsequent processing unit has grown. In parallel, it has become pivotal to fully understand and control manufacturing processes in line with in the quality-by-design paradigm. Formulation-generic prediction models would enormously facilitate digitally enhanced process development and require dedicated experimental data collection and process knowledge. To obtain this knowledge, three experimental campaigns were performed in this work. Firstly, an investigation into the effect of dryer process settings on drying behavior is presented. Secondly, the effect of active pharmaceutical ingredient properties on drying was assessed by producing granules of similar particle size and porosity and evaluating their drying and breakage behavior. Finally, additional experiments with varying active pharmaceutical ingredients and drug load were conducted to increase the genericity of the data set. This knowledge can be used in mathematical process modelling.

Keywords

• granulation
• fluid bed drying
• quality-by-design (QbD)
• powder technology