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Determining the Impact of Roller Compaction Processing Conditions on Granulate and API Properties: Impact of

James Clarke¹, John F Gamble², John W Jones³

¹School of Chemical Engineering, University of Birmingham, Birmingham, B15 2TT, UK.

AAPS Pharmscitech

|January 24, 2024

Summary

Roller compaction of theophylline formulations revealed that un-compacted fractions were not due to exceeding the percolation threshold. API attrition was consistent across all tested conditions, regardless of formulation or processing parameters.

Keywords:

Raman spectroscopy attrition dry granulation particle size percolation threshold

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Area of Science:

Pharmaceutical Technology
Materials Science
Chemical Engineering

Background:

Previous studies showed significant un-compacted fractions and particle size reduction during roller compaction of theophylline formulations.
These observations were hypothesized to be linked to the formulation exceeding the percolation threshold, affecting active pharmaceutical ingredient (API) compactability.

Purpose of the Study:

To investigate the impact of varying active pharmaceutical ingredient (API) loads on the un-compacted fraction and API particle attrition during roller compaction.
To test the hypothesis that observed phenomena in previous work were due to the formulation being above the percolation threshold.

Main Methods:

Roller compaction of theophylline formulations with varied API loads.
Assessment of the non-granulated fraction volume in the final granulate.
Quantification of API particle attrition within the non-granulated fraction.
Investigation of processing conditions, including roll pressure.

Main Results:

The volume of un-compacted material ranged from 34.7% to 65.5%, influenced by API load and roll pressure.
Results confirmed that the observed phenomena were not a consequence of exceeding the percolation threshold.
Active pharmaceutical ingredient (API) attrition was found to be equivalent across all tested formulation and processing conditions.

Conclusions:

The study refutes the percolation threshold hypothesis for the observed un-compacted fractions in theophylline roller compaction.
Formulation composition and processing conditions significantly influence the volume of un-compacted material.
Active pharmaceutical ingredient (API) attrition is independent of formulation and processing parameters within the tested range.