Rational Function-Based Approach for Integrating Tableting Reduced-Order Models with Upstream Unit Operations:
Sunidhi Bachawala1, Dominik Tomasz Nasilowski1, Marcial Gonzalez1,2
1School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Pharmaceuticals (Basel, Switzerland)
|October 29, 2025
Summary
A new modeling approach quantifies how glidants and lubricants affect tablet manufacturing. This helps predict and control tablet quality during continuous manufacturing processes.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Glidants and lubricants are essential pharmaceutical excipients that improve powder flow but can negatively affect tablet quality attributes.
- Understanding these impacts is crucial for the pharmaceutical industry's shift towards continuous manufacturing.
Purpose of the Study:
- To develop a rational-function-based modeling framework to quantify the effects of glidants and lubricants on tableting processes.
- To identify and model critical material attributes and process parameters influencing tablet quality.
Main Methods:
- Developed a rational-function-based modeling approach to capture lubricant and glidant effects on tableting.
- Constructed reduced-order models to assess variables like excipient concentration and mixing time on powder compaction stages.
- Utilized formulations with acetaminophen, microcrystalline cellulose, magnesium stearate, or colloidal silica, varying tablet density through process adjustments.
Main Results:
- Successfully quantified the impact of lubricant and glidant mixing on each stage of powder compaction.
- Provided mechanistic insights into how upstream conditions influence tableting and critical quality attributes.
- Demonstrated the model's ability to predict the effects of excipient concentration and mixing time.
Conclusions:
- The rational-function-based framework provides a systematic method for predicting lubricant and glidant effects on tablet performance.
- Enhances product and process understanding essential for optimizing continuous manufacturing.
- Facilitates better control over critical quality attributes in pharmaceutical tablet production.
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