Recent progress in roll compaction process development for pharmaceutical solid dosage form manufacture

June 11, 2020, midnight - by Ariel R. Muliadi , Alamelu Banda , Chen Mao

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Over the past decade, roll compaction technologies have seen significant advancements, becoming increasingly favored by formulation scientists for granulation purposes. This chapter provides an overview of recent developments in pharmaceutical roll compaction, focusing on three pivotal aspects: formulation development, process modeling, and equipment. In terms of modeling, various continuum-based modeling approaches are discussed, shedding light on their role in enhancing the fundamental understanding of the process. The discussion delves into the rolling theory for granular solids, examining both its accurate predictions and recurrent shortcomings in various process outcomes. Additionally, the chapter explores the emergence of high-fidelity computational simulations and their potential to address the limitations of the rolling theory. Concerning formulation development, the impact of common pharmaceutical excipients on the resulting ribbon and granule qualities is examined. The chapter also presents the current state of equipment design and process control, showcasing the capabilities of different roll compactor options. Special emphasis is placed on their precision in controlling roll force and roll gap, efficiency in deaeration, and effectiveness in minimizing powder leakage.

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