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

Area of Science:

• Pharmaceutical Manufacturing
• Chemical Engineering
• Materials Science

Background:

• Roller compaction dry granulation is crucial for manufacturing heat- or moisture-sensitive solid dosage forms.
• Scaling up this process from lab to industrial levels presents significant challenges due to complex parameter interactions.
• Inconsistent particle attributes and reduced production efficiency arise from scale-up difficulties.

Purpose of the Study:

• To systematically review mechanism-driven scale-up methods for roller compaction dry granulation.
• To integrate recent advancements in simulation technologies for process scale-up.
• To provide theoretical guidance and practical references for robust industrial production.

Main Methods:

• Review of model-based scale-up approaches, including the Johanson model.
• Analysis of numerical simulation techniques for understanding scale-up mechanisms.
• Integration of data-driven optimization strategies and simulation technologies.

Main Results:

• Identified complex coupling effects among compaction force, roller gap, roller speed, and material properties during scale-up.
• Demonstrated how these effects alter particle size distribution and solid fraction, impacting product consistency.
• Highlighted the role of advanced models and simulations in predicting and managing scale-up alterations.

Conclusions:

• Mechanism-driven scale-up methods, particularly those using numerical simulation, are vital for addressing roller compaction challenges.
• Predictive scale-up models are essential for ensuring product consistency and efficiency in industrial manufacturing.
• This review offers a framework for optimizing the scale-up and industrial application of roller compaction dry granulation.