Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing

Abstract

Introduction: The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of the raw materials. Existing knowledge on the role of raw material properties in batch processing is however not directly transferable to continuous processes, due to the inherent differences between batch and continuous processes.

Areas covered: A review is performed to evaluate the role of excipient properties for different unit operations used in continuous manufacturing processes. Unit operations that will be discussed include feeding, blending, granulation, final blending, and compression.

Expert opinion: Although the potency of continuous manufacturing is widely recognized, full utilization still requires a number of challenges to be addressed effectively. An expert opinion will be provided that discusses those challenges and potential solutions to overcome those challenges. The provided overview can serve as a framework for the pharmaceutical industry to push ahead process optimization and formulation development for continuous manufacturing processes.

Keywords: Continuous manufacturing; Quality-by-design; continuous processing; excipients; lactose; material characterization; material properties; microcrystalline cellulose.