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A comprehensive analysis and optimization of continuous twin-screw granulation processes via sequential

Wei Meng1, Kallakuri Suparna Rao2, Ronald D Snee3

  • 1Department of Pharmaceutics, Rutgers University, Piscataway, NJ 08854, USA.

International Journal of Pharmaceutics
|December 16, 2018
PubMed
Summary

Twin-screw granulation optimization using sequential experimentation enhances process understanding. Higher liquid saturation improves granule properties but may reduce tablet strength and slow drug release.

Keywords:
Continuous manufacturingDesign of experimentsQuality by designStrategy of experimentationTwin-screw granulation

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Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Materials Science

Background:

  • Continuous wet granulation using twin-screw granulators is an emerging technique.
  • Optimizing process parameters is crucial for consistent product quality.

Purpose of the Study:

  • To improve the design and understanding of twin-screw granulation processes.
  • To bridge the knowledge gap between input and output variables using sequential experimentation.

Main Methods:

  • Employed a sequential experimentation strategy involving parameter screening (D-optimal design, stepwise regression) and characterization (response surface design).
  • Used anhydrous caffeine as a model drug in a low-dose formulation.
  • Identified optimal screw configuration parameters: 700 rpm screw speed, 60° kneading element staggering, 5 kneading elements, and distributive feed screw.

Main Results:

  • Liquid-to-solid (L/S) ratio was identified as the most influential parameter, more so than throughput and barrel temperature.
  • Increased liquid saturation resulted in granules with narrower particle size distribution and reduced porosity.
  • Enhanced granule flowability was observed with higher liquid saturation.
  • Tablets exhibited decreased tensile strength and slower drug release as liquid saturation increased.

Conclusions:

  • Sequential experimentation effectively optimizes twin-screw granulation processes.
  • Controlling L/S ratio is critical for achieving desired granule attributes.
  • Trade-offs exist between granule properties, tablet mechanical strength, and drug release profiles.