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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
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Summary
This summary is machine-generated.

A new modeling approach quantifies how glidants and lubricants affect tablet manufacturing. This helps predict and control tablet quality during continuous manufacturing processes.

Keywords:
bivariate rational functionsglidantslubricantsreduced-order modelstableting

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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.