Model-based approach to the design of pharmaceutical roller-compaction processes

Area of Science:

• Pharmaceutical Engineering
• Process Chemistry
• Materials Science

Background:

• Roller compaction is a critical unit operation in pharmaceutical manufacturing for granulation and таблет production.
• Accurate process design and scale-up are essential for reproducible product quality and efficient manufacturing.
• Current methods often lack predictive power for defining optimal operating conditions across different scales.

Purpose of the Study:

• To develop and validate a novel model-based approach for roller compaction process design and scale-up.
• To integrate low-throughput experimental data for enhanced mechanistic model calibration and prediction.
• To identify and validate 'sweet spots' within the operating space for improved process control.

Main Methods:

• Development of a mechanistic model for roller compaction.
• Iterative calibration routine using low-throughput experimental data.
• Validation using a design of experiments approach with two ibuprofen formulations.
• Prediction and comparison of operating spaces at different throughputs.

Main Results:

• The model-based approach successfully predicts the operating space for roller compaction.
• Low-throughput data significantly improved the predictive accuracy of mechanistic models.
• Validated model predictions showed good agreement with experimental results for ibuprofen formulations.
• Identified 'sweet spots' in the operating space were consistent with experimental findings.

Conclusions:

• The proposed model-based approach enables effective process design and scale-up in roller compaction.
• Integrating experimental data into mechanistic models enhances predictive capabilities.
• This methodology offers a robust strategy for optimizing roller compaction processes and ensuring consistent product quality.