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A mechanistic framework for predicting tablet disintegration: Integrating the Representative Capillary Evolution
Jongmin Lee1, Jessica Hancock1, Daniel J Goodwin2
1Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge CB3 0AS, UK.
International Journal of Pharmaceutics
|October 15, 2025
Summary
Predicting pharmaceutical tablet disintegration is now possible with a new framework. This approach combines advanced imaging and computational models to link material properties and processing to drug release performance.
Area of Science:
- Pharmaceutical Sciences
- Computational Modeling
- Materials Science
Background:
- Tablet disintegration is crucial for drug release but difficult to predict.
- Current methods lack mechanistic understanding of complex disintegration processes.
Purpose of the Study:
- To develop a novel, mechanistically grounded framework for predicting immediate-release tablet disintegration.
- To integrate experimental data with computational models for a comprehensive approach.
Main Methods:
- Utilized Terahertz Pulsed Imaging (TPI) for real-time monitoring of liquid transport and matrix erosion.
- Employed the Representative Capillary Evolution Model (RCEM) and Dynamic Void Fraction Evolution Model (DVFEM).
- Integrated models using a Representative Capillary (RC) concept and proposed an iterative calibration strategy.
Main Results:
- The framework successfully links Critical Material Attributes (CMAs) and Critical Processing Parameters (CPPs) to disintegration.
- Demonstrated a method to account for simultaneous matrix erosion and liquid transport kinetics.
- Showcased the potential for machine learning enhancement in model calibration.
Conclusions:
- The developed framework provides a pathway to predict tablet disintegration behavior.
- This approach aligns with Quality by Design (QbD) principles.
- The framework has the potential to accelerate pharmaceutical formulation development and improve drug product performance.
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