Mapping key process parameters to the performance of a continuous dry powder blender in a continuous direct compression system
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Abstract
This work aims to expand the typical raw material attributes that can successfully be processed on a continuous direct compression line with a particular focus on the continuous dry powder blender. Three grades of Acetaminophen were investigated as model active pharmaceutical ingredients and chosen to span a broad range of material attributes wider than what would normally be considered for a direct compression process. An experimental design was set-up for each grade of Acetaminophen to investigate the effect of throughput, impeller speed and impeller configuration on the critical process responses and attributes. The strain experienced by the in-process material was found critical to improve content uniformity. The impeller speed and design can be optimised at a given throughput to obtain a strain which would deliver the required content homogeneity. The content uniformity of the final tablets can be modelled as a function of the strain using an exponential decay model. (C) 2019 Elsevier B.V. All rights reserved.
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Affiliations
- AstraZeneca
- GM Group Ltd
- Percept Engn Ltd, GlaxoSmithKline Res & Dev Ltd
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Classification Areas
- Oral solid dose
- Process and material characterization, and modeling