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Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw

Christoph Portier1, Kenny Pandelaere1, Urbain Delaet2

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Summary

Continuous twin-screw wet granulation is vital for pharmaceutical production. This study found liquid-to-solid ratio and kneading element design significantly impact granule quality, with lactose/MCC/HPMC showing promise as a platform formulation.

Keywords:
Continuous manufacturingDesign of experimentsFormulationGranule qualityProcess variableTwin screw granulationWet granulation

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Continuous manufacturing offers advantages over traditional batch processes in pharmaceutical production.
  • Twin-screw wet granulation is a key continuous manufacturing technique with a significant knowledge gap regarding formulation variable impacts.
  • Understanding these impacts is crucial for optimizing granule quality and process efficiency.

Purpose of the Study:

  • To systematically assess the influence of screw configurations and process parameters on twin-screw wet granulation.
  • To evaluate the effects of varying filler types, active pharmaceutical ingredient (API) characteristics, and drug loads on granule properties.
  • To identify optimal formulation strategies and platform formulations for continuous granulation.

Main Methods:

  • Eight model formulations were designed with variations in filler type (lactose, lactose/MCC), API characteristics, and drug load.
  • Twin-screw wet granulation experiments were conducted using different screw configurations (kneading element thickness, L/D ratio, distribution) and process settings (barrel fill level, L/S ratio).
  • Granule critical quality attributes (CQAs) including size, flow, and strength were analyzed.

Main Results:

  • The liquid-to-solid (L/S) ratio was the most influential variable across all formulations.
  • Kneading element thickness, specifically narrow elements with a 1/6 L/D ratio, negatively impacted granule size, flow, and strength compared to 1/4 L/D elements.
  • Formulations with lactose/MCC filler were less sensitive to screw configurations and process settings, especially at high drug loads of poorly soluble APIs like mebendazole.
  • Lactose/MCC/HPMC emerged as a promising platform formulation due to its robustness.

Conclusions:

  • Screw configuration, particularly kneading element design, and L/S ratio are critical parameters in twin-screw wet granulation.
  • Formulation composition, specifically the inclusion of MCC, enhances robustness against process variations and API challenges.
  • The lactose/MCC/HPMC formulation demonstrates significant potential as a versatile platform for continuous granulation.