Using in-line measurement and statistical analyses to predict tablet properties compressed using a Styl'One compaction simulator: A high shear wet granulation study.

Abstract

High shear wet granulation (HSWG) is widely used in tablet manufacturing mainly because of its advantages in improving flowability, powder handling, process run time, size distribution, and preventing segregation. In-line process analytical technology measurements are essential in capturing detailed particle dynamics and presenting real-time data to uncover the complexity of the HSWG process and ultimately for process control. This study is to find relationships between Lenterra in-line measurements and granule properties and tablet properties. The Styl'One Evolution compaction simulator was used to produce tablets that mimic an industrial rotary tablet press, which is different from the Gamlen used in our previous study. Furthermore, this research provided an understanding of the granule growth mechanisms during the granulation process, revealing that an induction granule growth mechanism occurs. This is specific to the material and process conditions studied. The model developed using data from a Gamlen tabletting press demonstrated high predictability for data generated using the Styl'One Evolution compaction simulator, with an R² value of 0.9535 and a RMSE of 0.4040 MPa. This finding highlights the ability of the model to predict tablet tensile strength independently of the compaction machine used, suggesting industrial-scale applications. The findings of this research provide substantial advances in understanding and monitoring the granulation process, with promising implications for scalable industrial processes.