Scientific papers
High shear wet granulation (HSWG) is a widely adopted method in tablet manufacturing due to its benefits, including improved flowability, enhanced powder handling, optimized process runtime, controlled size distribution, and minimized segregation. In-line process analytical technology (PAT) plays a crucial role in capturing particle dynamics and providing real-time data to better understand the complexities of the HSWG process and enhance process control.
This study investigates the relationship between Lenterra in-line measurements, granule properties, and tablet characteristics. Tablets were produced using the STYL'One Evolution compaction simulator, which replicates the performance of an industrial rotary tablet press—marking a departure from the Gamlen press used in earlier research. The study also sheds light on granule growth mechanisms during granulation, identifying an induction growth mechanism specific to the materials and process conditions examined.
The predictive model developed from Gamlen tabletting press data exhibited high accuracy when applied to STYL'One Evolution data, achieving an R² value of 0.9535 and an RMSE of 0.4040 MPa. This demonstrates the model's ability to predict tablet tensile strength regardless of the compaction equipment used, highlighting its potential for industrial-scale applications. Overall, the research offers significant insights into granulation process monitoring and control, paving the way for scalable industrial implementations.
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