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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Reevaluation of the diametral compression test for tablets using the flattened disc geometry.

V Mazel1, S Guerard2, B Croquelois1

  • 1Univ. Bordeaux, CNRS, Bordeaux INP, Arts et Métiers ParisTech, I2M, UMR 5295, F-33000 Bordeaux, France.

International Journal of Pharmaceutics
|October 6, 2016
PubMed
Summary

A new flattened disc geometry improves tablet mechanical strength testing. This method ensures accurate tensile strength measurement by locating stress and strain at the tablet

Keywords:
CompressionDiametral compressionNumerical simulationTabletTensile strength

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Mechanical Engineering

Background:

  • Tablet mechanical strength is a critical quality attribute in pharmaceuticals.
  • Traditional diametral compression tests may yield inaccurate tensile strength due to contact issues and off-center failure.
  • Alternative geometries are needed to ensure reliable mechanical testing of tablets.

Purpose of the Study:

  • To investigate a flattened disc geometry as an alternative to standard geometry for tablet diametral compression testing.
  • To determine if the flattened geometry improves the accuracy of tensile strength measurements.
  • To analyze stress and strain distribution during diametral compression using both geometries.

Main Methods:

  • Finite Element Method (FEM) simulations were performed on standard and flattened tablet geometries.
  • Digital Image Correlation (DIC) was used for experimental validation of numerical results.
  • High-speed video capture analyzed crack initiation during diametral compression tests.

Main Results:

  • FEM simulations showed maximum tensile stress and strain localized at the center for the flattened geometry, unlike the standard geometry.
  • Experimental DIC confirmed these numerical findings.
  • The flattened geometry consistently yielded higher tensile strength values compared to the standard geometry.
  • High-speed video revealed crack initiation away from the center in the standard geometry.

Conclusions:

  • The flattened disc geometry offers a more reliable method for measuring tablet tensile strength.
  • This improved geometry mitigates issues associated with off-center failure in traditional diametral compression tests.
  • Accurate mechanical strength assessment is crucial for tablet quality control and performance.