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Evaluation of manufacturing process parameters causing multilayer tablets delamination.

Marco Bellini1, Mathias Walther2, Roland Bodmeier1

  • 1College of Pharmacy, Freie Universität Berlin, Kelchstr. 31, 12169 Berlin, Germany.

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|August 18, 2019
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Summary

Optimizing tableting parameters like main compaction pressure and turret rotation speed is crucial for bilayer tablet adhesion. Main compaction pressure significantly impacts layer adhesion, especially with plastic excipients at high pressures.

Keywords:
Bilayer tabletsDelaminationElastic recoveryLayer adhesion

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Bilayer tablets offer advantages in drug delivery by combining immediate and controlled release profiles.
  • Ensuring adequate layer adhesion is critical for the mechanical integrity and performance of bilayer tablets.

Purpose of the Study:

  • To investigate the impact of tableting process parameters on the layer adhesion of bilayer tablets.
  • To identify key parameters influencing delamination and optimize formulations for enhanced tablet integrity.

Main Methods:

  • Utilized a Design of Experiment (DOE) approach with three factors (turret rotation speed, pre-compaction, and main compaction pressures) at three levels.
  • Assessed layer adhesion using a custom-made shear test, with elastic recovery serving as an indicator of material elasticity.
  • Evaluated three pharmaceutical formulations combining immediate and controlled drug release excipients.

Main Results:

  • Main compaction pressure and turret rotation speed were identified as the most significant parameters affecting layer adhesion.
  • High main compaction pressures, particularly with plastic excipients, led to delamination, influenced by differences in excipient elasticity.
  • Turret rotation speed did not significantly affect layer adhesion in formulations containing brittle excipients.

Conclusions:

  • Tableting process parameters, especially main compaction pressure, must be carefully controlled to ensure bilayer tablet layer adhesion.
  • Formulation composition, particularly the elasticity of excipients, plays a critical role in the susceptibility to delamination under specific tableting conditions.