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Comparison of scale-up strategies in twin-screw wet granulation

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This study aimed to evaluate different scale-up strategies in twin-screw wet granulation and assess their impact on granule and tablet properties for a specific formulation. The granulation process was transitioned from a QbCon® 1 with a 16 mm screw diameter to a QbCon® 25 line with a 25 mm screw diameter for scale-up. Three distinct scale-up strategies were implemented, varying in process parameters and their consequential effects, such as the powder feed number (as a representation of barrel fill level) and circumferential speed, both influenced by screw diameter and screw speed (SS). The barrel fill level also relies on overall throughput. Despite substantial differences in powder feed number, circumferential speed, overall throughput, and SS, as well as the consequential variations in granule size due to the larger gap size in the larger-scale granulator, these differences were rectified after milling. Surprisingly, the tablet and granule properties were remarkably similar on both scales, regardless of the applied scale-up strategies. For the chosen formulation, the impact of altering the liquid-to-solid ratio at the same scale proved to be more significant than the differences among scale-up strategies. These findings suggest the potential for a robust granulation process, promising a consistent outcome in tablet properties during the scale-up from lab to production scale in twin-screw wet granulation.
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