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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
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Rational Function-Based Approach for Integrating Tableting Reduced-Order Models with Upstream Unit Operations: Dry

Sunidhi Bachawala1, Rexonni B Lagare2, Abigail B Delaney2

  • 1School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA.

Pharmaceuticals (Basel, Switzerland)
|September 28, 2024
PubMed
Summary
This summary is machine-generated.

This study introduces a systematic method to link powder processing (dry granulation) with tablet making. It identifies key factors affecting tablet quality and provides a mathematical model for process optimization.

Keywords:
bivariate rational functionsdry granulationgranule size distributionreduced-order modelsribbon densitytableting

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Integrating upstream unit operations with downstream processes like tableting is crucial for pharmaceutical manufacturing.
  • Dry granulation is commonly used to improve powder flow but can negatively impact tabletability.
  • Understanding the complex interplay between granule properties and tablet performance is essential for process control.

Purpose of the Study:

  • To develop a systematic and automatic approach for integrating reduced-order models of tableting with upstream unit operations.
  • To identify critical material attributes and process parameters governing the coupling between dry granulation and tableting.
  • To establish a mathematical framework for describing and predicting this coupling.

Main Methods:

  • Proposed a novel approach using normalized bivariate rational functions to model the coupling.
  • Demonstrated the method using a 10% acetaminophen and 90% microcrystalline cellulose formulation.
  • Fabricated granules with varying densities and size distributions, and produced tablets across a range of relative densities.

Main Results:

  • Successfully identified critical attributes and parameters linking dry granulation to tableting.
  • Quantified the impact of granule properties on powder compaction stages (die filling, compaction, unloading, ejection).
  • Validated the proposed mathematical model for describing the process coupling.

Conclusions:

  • The developed approach enables end-to-end integration, control, and optimization of dry granulation and tableting.
  • Provides valuable insights into granule properties influencing powder compaction.
  • Facilitates a deeper understanding of product and process relationships in pharmaceutical manufacturing.