Strategies and research progress of roller compaction process in dry granulation scale-up process.

Roller compaction dry granulation is one of the pivotal dry granulation technologies in solid dosage form manufacturing, offering irreplaceable advantages in processing heat-sensitive or moisture-sensitive materials. With the advancement of large-scale production and intelligent manufacturing in the pharmaceutical industry, the scale-up challenge of roller compaction dry granulation from laboratory-scale to industrial-scale production has gradually emerged as a critical bottleneck restricting its widespread application. During the scale-up process, the complex coupling effects among parameters such as compaction force, roller gap, roller speed, and material properties can induce significant alterations in particle quality attributes (e.g., particle size distribution, solid fraction), thereby compromising product consistency and production efficiency. In recent years, emerging research efforts-including model-based scale-up approaches, the Johanson model, numerical simulation, and data-driven optimization strategies-have been continuously advancing. These endeavors have played a proactive role in unraveling the mechanistic correlations during scale-up and establishing predictable scale-up models. This review systematically expounds on mechanism-driven scale-up methods (e.g., those based on the Johanson model and numerical simulation), integrates the latest research progress in the application of simulation technologies, and clarifies the core principles and implementation strategies for process scale-up. It aims to provide theoretical guidance and practical references for the robust scale-up and industrial production of the roller compaction dry granulation process.