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A hybrid system for design space estimation in a rotary tablet press
Mohammad Shahab1, Sunidhi Bachawala2, Marcial Gonzalez2
1Davidson School of Chemical Engineering, Purdue University, West Lafayette, 47907, IN, USA.
International Journal of Pharmaceutics
|May 16, 2025
Summary
Identifying the pharmaceutical tablet press design space (DS) is key for quality-by-design (QbD). A hybrid approach using semi-mechanistic and data-driven models effectively defines the DS for glidant and lubricant blends, ensuring tablet quality.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Process Analytical Technology
Background:
- Quality-by-Design (QbD) mandates robust Design Space (DS) identification for pharmaceutical manufacturing.
- Tablet Presses (TPs) are critical unit operations where material attributes and process conditions influence final product quality.
- Existing models may be insufficient for comprehensive DS estimation, necessitating advanced approaches.
Purpose of the Study:
- To develop and validate a hybrid system for identifying the DS in tablet compression.
- To evaluate the efficacy of different modeling approaches for various blend types (glidant vs. lubricant).
- To ensure tablet quality constraints are met within the identified DS.
Main Methods:
- Implementation of a hybrid modeling system combining semi-mechanistic and data-driven (response surface) models.
- Characterization of DS for glidant-based blends using a semi-mechanistic model.
- Application of a data-driven response surface model for lubricant-based blends.
- Experimental validation of the hybrid system's identified DS.
Main Results:
- A hybrid system effectively identifies the DS for tablet presses, accommodating different material attributes.
- Semi-mechanistic models are suitable for glidant blends, while data-driven models excel for lubricated blends.
- The hybrid approach accounts for model uncertainty and material-process interactions, defining quality-driven DS contours.
- Experimental studies confirmed the hybrid system's superior efficacy compared to a purely mechanistic approach.
Conclusions:
- The hybrid system offers an efficient and accurate method for DS identification in tablet compression.
- Tailoring modeling strategies to blend type (glidant/lubricant) is crucial for optimal DS definition.
- This approach reduces experimental costs while ensuring product quality and process robustness.
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