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The effect of material properties and process parameters on die filling using double-tip tooling: A PLS-model-based
L De Souter1, B J Nitert2, T De Beer1
1Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.
International Journal of Pharmaceutics
|January 22, 2025
Summary
Double-tip tooling enhances tablet press throughput without increasing speed. This study models formulation effects on die filling, predicting variability and reducing R&D experiments.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Tablet press turret speed increases can negatively impact die filling, causing weight variability.
- Double-tip tooling offers a solution by doubling throughput without increasing turret speed.
Purpose of the Study:
- To investigate the impact of formulation material properties and process settings on die filling performance with double-tip tooling.
- To develop a predictive model for die filling variability.
Main Methods:
- Utilized partial least squares (PLS) modeling to regress formulation and process variables (X) against die filling performance (Y).
- Analyzed the relationship between material properties, process settings, and die filling uniformity for multi-tip punches.
Main Results:
- Developed a PLS model capable of predicting die filling performance for double-tip tooling.
- Demonstrated that the model can estimate die filling variability using material characterization data.
Conclusions:
- The developed PLS model accurately assesses die filling performance and variability for double-tip tooling.
- This approach reduces the need for extensive tableting experiments, saving time and material resources in pharmaceutical R&D.
