Peer-Reviewed Journal Details
Mandatory Fields
Moroney K.M.;Cronin P.;Adeleye O.A.;Schaller B.E.;Howard M.A.;Castro-Dominguez B.;Ramachandran R.;Walker G.M.
Powder Technology
An evaluation of the Johanson model for roller compaction process development for a high dose API
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Optional Fields
Dry granulation High dose API Johanson model Pharmaceutical process modelling Ribbon density Roller compaction
2020 Elsevier B.V. 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.
Grant Details