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A dimensionless variable for the scale up and transfer of a roller compaction formulation.

Nathan Boersen1, David Belair1, Garnet E Peck1

  • 1a Department of Industrial and Physical Pharmacy , Purdue University , West Lafayette , IN USA.

Drug Development and Industrial Pharmacy
|April 9, 2015
PubMed
Summary

This study introduces a dimensionless variable to scale roller compaction processes between different equipment. This method aids in transferring formulations and predicting ribbon porosity, improving pharmaceutical manufacturing efficiency.

Keywords:
Dimensionless variableoperating parametersribbon porosityroller compactionscale up

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Roller compaction is a key dry granulation technique in pharmaceuticals.
  • Current limitations include a lack of scalable parameter sets for equipment transfer.
  • This gap hinders efficient formulation development and manufacturing.

Purpose of the Study:

  • To investigate a dimensionless variable for scaling roller compaction parameters.
  • To establish a relationship between operating parameters, raw material attributes, and ribbon porosity.
  • To enable formulation transferability across different roller compaction equipment.

Main Methods:

  • Examined dimensionless variables for parameter transfer.
  • Hypothesized relationships between ribbon porosity and operating parameters.
  • Developed and tested a specific dimensionless variable (RP/RS*HFS*True Density*D²) for correlation with ribbon porosity.

Main Results:

  • The dimensionless variable showed a strong correlation with ribbon porosity.
  • Average differences in ribbon porosity between equipment ranged from 0.012 to 0.024.
  • The findings support the hypothesis that a dimensionless approach can facilitate equipment transfer.

Conclusions:

  • A dimensionless variable can effectively correlate roller compaction operating parameters with ribbon porosity.
  • This approach provides a foundation for scaling and transferring formulations between different equipment.
  • The study advances pharmaceutical dry granulation by offering a method for process optimization and transfer.