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A review of regime maps for granulation
Sebastian Pohl1, Peter Kleinebudde2
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstrasse 1, Building 26.22, 40225 Düsseldorf, Germany; INVITE GmbH, Drug Delivery Innovation Center, Chempark, Building W32, 51368 Leverkusen, Germany.
International Journal of Pharmaceutics
|July 22, 2020
Summary
Understanding granulation mechanisms and using dimensionless correlations allows for process design and prediction. Regime maps help define scale-independent operation windows for solid dosage form production.
Area of Science:
- Pharmaceutical Technology
- Chemical Engineering
- Materials Science
Background:
- Granulation is a key size enlargement technique for producing solid dosage forms.
- Various granulation methods exist, including roll compaction, drum granulation, high shear, twin-screw, and fluid-bed granulation.
Purpose of the Study:
- To critically discuss proposed regime maps for different granulation processes.
- To highlight the importance of fundamental knowledge on granule growth mechanisms for process design.
- To explain how dimensionless correlations can define scale-independent operation windows.
Main Methods:
- Review of existing literature on granulation processes and regime maps.
- Analysis of dimensionless correlations for granulation process physics.
- Discussion of the relationship between input variables, granule attributes, and growth behavior.
Main Results:
- Dimensionless correlations can define operation windows with distinct regime areas.
- Regime maps facilitate the prediction of granulation system behavior under changing parameters.
- The use of dimensionless numbers reduces experimental workload and parameter dependency.
Conclusions:
- A thorough understanding of granule growth mechanisms is crucial for effective granulation process design.
- Regime maps, based on dimensionless correlations, offer a powerful tool for scale-independent process definition.
- This approach enables better prediction and control of granule attributes in solid dosage form manufacturing.
Keywords:
Dry granulationGranule formationGranule growthHot-melt granulationRegime mapWet granulation
