Scientific papers
Roller compaction dry granulation is a key technology in the manufacture of solid dosage forms, offering significant advantages for materials that are sensitive to heat or moisture. As pharmaceutical manufacturing continues to evolve toward larger production scales and more advanced, data-driven operations, the transition from laboratory- to industrial-scale roller compaction has become a major challenge. Scale-up is complicated by the strong interdependence between process variables, including compaction force, roller gap, roller speed, and material characteristics. These interactions can substantially affect critical granule attributes such as particle size distribution and solid fraction, ultimately influencing product quality, consistency, and manufacturing performance.
Recent advances in scale-up methodologies, including model-based approaches, applications of the Johanson model, numerical simulation techniques, and data-driven optimization strategies, have enhanced the understanding of process behavior across scales. These developments have contributed to the establishment of more reliable and predictive scale-up frameworks while improving insight into the mechanisms governing granule formation. This review provides a comprehensive overview of mechanism-based scale-up strategies, with particular emphasis on approaches derived from the Johanson model and numerical simulations. In addition, it summarizes recent progress in simulation-assisted process development and outlines key principles and practical considerations for successful scale-up. The objective is to support robust industrial implementation of roller compaction dry granulation through both theoretical and practical guidance.
Comments
No comments posted yet.
Add a comment
Articles you may like
Related products
Looking for additional information?
Let us help you