Adeleye, Opeyemi A.

Castro-Dominguez, Bernardo

Cronin, Patrick

Howard, Matthew A.

Moroney, Kevin M.

Ramachandran, Rohit

Schaller, Barbara E.

Walker, Gavin M.

English

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.</p

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

https://purehost.bath.ac.uk/ws/files/204134846/1_s2.0_S0032591020301649_main.pdf

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

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