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Roll compaction process modeling: transfer between equipment and impact of process parameters.

Nabil Souihi1, Gavin Reynolds2, Pirjo Tajarobi3

  • 1Computational Life Science Cluster (CLiC), Department of Chemistry, Umeå University, Sweden; Industrial Doctoral School, Umeå University, Umeå, Sweden.

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Summary

Roll compaction processes were analyzed using horizontal and vertical force fed compactors. Normal stress and roll force directly impact ribbon porosity, with models effectively predicting scale-up parameters.

Keywords:
Dry granulationInstrumented rollJohanson modelOrthogonal projections to latent structuresRoll compaction modelingScale up

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Area of Science:

  • Pharmaceutical Engineering
  • Materials Science
  • Chemical Engineering

Background:

  • Roll compaction is a critical unit operation in pharmaceutical manufacturing for producing granules and tablets.
  • Understanding the relationship between process parameters and ribbon properties is essential for successful scale-up and process control.

Purpose of the Study:

  • To investigate the roll compaction of an intermediate drug load formulation using different compactor configurations.
  • To characterize the influence of normal stress and roll force on ribbon porosity.
  • To evaluate the predictive capability of the Johanson model and develop a latent variable model for scale-up.

Main Methods:

  • Roll compaction using horizontally and vertically force fed roll compactors with instrumented rolls or force gauges.
  • Characterization of compacted ribbons, granules, and tablets.
  • Application of the Johanson model for peak pressure prediction.
  • Development and validation of a latent variable model.

Main Results:

  • Ribbon porosity showed a quadratic relationship with normal stress and roll force.
  • Predicted peak pressure (Pmax) using the Johanson model correlated well with ribbon porosity and downstream properties.
  • The developed latent variable model accurately predicted ribbon porosity based on geometric and process parameters.
  • Successful demonstration of scale-up/transfer between different roll compactor types.

Conclusions:

  • Normal stress and roll force are critical process parameters influencing ribbon porosity in roll compaction.
  • The Johanson model provides a scale-independent parameter (Pmax) for predicting roll compaction outcomes.
  • Integrated approaches using design of experiments, latent variable models, and in silico predictions enhance the understanding of critical process parameters for effective scale-up.