An evaluation of the Johanson model for roller compaction process development for a high dose API

Kevin M. Moroney, Patrick Cronin, Opeyemi A. Adeleye, Barbara E. Schaller, Matthew A. Howard, Bernardo Castro-Dominguez, Rohit Ramachandran, Gavin M. Walker

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Roller compaction (RC) is a dry granulation technique applied to improve the flow and compressibility of drug formulations. RC implementation for high drug load formulations can be challenging due to flow issues and a high consumption of active pharmaceutical ingredient (API) for robust process development. This work addresses these challenges using process modelling for design and scale-up of an RC process on the same equipment and transfer to different equipment. A modified application of existing models incorporating a new description of mass transport in the feed screw is evaluated for guaifenesin formulations with a 90% drug loading. The model is calibrated using low-throughput data on a Vector Freund TF Mini RC and used to predict ribbon density and throughput for various process settings at high-throughput. It is found that the modelling framework can reasonably predict high-throughput behaviour on the same RC but the predictive performance decreases for transfer between equipment.

Original languageEnglish
Pages (from-to)82-95
Number of pages14
JournalPowder Technology
Volume366
Early online date25 Feb 2020
DOIs
Publication statusPublished - 15 Apr 2020

Keywords

  • Dry granulation
  • High dose API
  • Johanson model
  • Pharmaceutical process modelling
  • Ribbon density
  • Roller compaction

ASJC Scopus subject areas

  • Chemical Engineering(all)

Cite this

Moroney, K. M., Cronin, P., Adeleye, O. A., Schaller, B. E., Howard, M. A., Castro-Dominguez, B., Ramachandran, R., & Walker, G. M. (2020). An evaluation of the Johanson model for roller compaction process development for a high dose API. Powder Technology, 366, 82-95. https://doi.org/10.1016/j.powtec.2020.02.058