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Simplifying Johanson's roller compaction model to build a "Virtual Roller Compactor" as a predictive tool - Theory
Chi So1, Lap Y Leung1, Ariel R Muliadi1
1Small Molecule Pharmaceutical Sciences, Genentech, Inc., South San Francisco, CA 94080, United States.
International Journal of Pharmaceutics
|April 11, 2021
Summary
A new virtual roller compactor predicts pharmaceutical roller compaction performance. The simplified model accurately forecasts roll force and ribbon density, reducing material needs for formulation development.
Area of Science:
- Pharmaceutical Engineering
- Materials Science
- Process Modeling
Background:
- Roller compaction is crucial for pharmaceutical manufacturing.
- Predicting roll force (RF) and ribbon density is challenging.
- Existing models often require extensive material characterization.
Purpose of the Study:
- Develop a "virtual roller compactor" predictive tool.
- Assess the roll force (RF)-maximum pressure (Pmax) and RF-ribbon density relationship.
- Simplify existing models for pharmaceutical roller compaction.
Main Methods:
- Theoretical analysis to identify a critical nip angle.
- Experimental validation using manufacturing-scale roller compaction.
- Development of a user-friendly graphical interface based on a simplified model.
Main Results:
- A critical nip angle exists, simplifying the RF-Pmax relationship beyond it.
- A simplified, friction angle-free model shows good predictive performance.
- The virtual roller compactor tool demonstrates ease-of-use and accuracy.
Conclusions:
- The simplified model effectively predicts pharmaceutical roller compaction.
- The virtual roller compactor is a valuable tool for formulation development and scale-up.
- Reduced material demand and improved prediction enhance process efficiency.
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