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 language | English |
|---|---|
| Pages (from-to) | 82-95 |
| Number of pages | 14 |
| Journal | Powder Technology |
| Volume | 366 |
| Early online date | 25 Feb 2020 |
| DOIs | |
| Publication status | Published - 15 Apr 2020 |
Funding
This publication has emanated from research supported in part by a research grant from Science Foundation Ireland (SFI) ?Modelling of Multi-Phase Transport Processes to Enable Automation in Manufacturing, (MOMEnTUM)? and is co-funded under the European Regional Development Fund under Grant Number 14/SP/2750, in partnership with Janssen Pharmaceuticals. Opeyemi A. Adeleye acknowledges support from Faculty of Life Sciences, Rhine-Waal University of Applied Sciences, Germany.
Keywords
- Dry granulation
- High dose API
- Johanson model
- Pharmaceutical process modelling
- Ribbon density
- Roller compaction
ASJC Scopus subject areas
- General Chemical Engineering