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Tablet capping predictions of model materials using multivariate approach.

Pratap Basim1, Rahul V Haware1, Rutesh H Dave2

  • 1Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY, USA.

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|August 3, 2019
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Summary
This summary is machine-generated.

This study predicts tablet capping causes by analyzing powder properties and mechanical behavior for Acetaminophen (APAP) and Ibuprofen (IBU). Findings reveal distinct air-induced and deformation-induced capping mechanisms for each drug, aiding tablet quality optimization.

Keywords:
Air entrapmentCappingElastic deformationMultivariate analysisPlastic deformationPowder cohesionPowder rheology

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Tablet capping is a common manufacturing defect affecting drug product quality.
  • Understanding the root causes of capping is crucial for optimizing tablet formulations and production processes.
  • Powder rheology and mechanical properties significantly influence tabletability and defect formation.

Purpose of the Study:

  • To predict the predominant root causes of capping behavior in Acetaminophen (APAP) and Ibuprofen (IBU) tablets.
  • To differentiate the mechanisms underlying capping for APAP and IBU based on their powder and mechanical properties.
  • To establish a quantitative approach for identifying and controlling factors contributing to tablet capping.

Main Methods:

  • Analysis of powder rheological properties: permeability, pressure drop, and cohesion.
  • Measurement of compact mechanical properties: porosity, internal air pressure, Brinell hardness, and tensile strength.
  • Application of multivariate techniques, including Principal Component Analysis (PCA) and Principal Component Regression (PCR), for data evaluation.

Main Results:

  • PCA identified positive correlations between capping potential and pressure drop, cohesion, API amount, and compression pressure.
  • Negative correlations with capping potential were observed for permeability, porosity, internal air pressure, Brinell hardness, and tensile strength.
  • APAP and IBU exhibited distinct capping mechanisms: APAP showed an exponential relationship, while IBU followed a linear one, with APAP capping linked to powder properties and IBU capping to deformation properties.

Conclusions:

  • APAP and IBU compacts demonstrate distinct capping behaviors: air-induced for APAP and deformation-induced for IBU.
  • The study provides a predictive approach to understand capping mechanisms and optimize tablet manufacturing.
  • This methodology can enhance tablet quality control and formulation development by identifying critical material attributes.