In-line measurement to determine high shear wet granulation end point to generate desired tablet properties

Abstract

High shear wet granulation (HSWG) is widely used in tablet manufacturing because it enhances flowability, powder handling, process run time, size distribution, and prevents segregation. In-line process analytical technology captures particle dynamics and provides real-time data to understand and monitor the HSWG process. The purpose of this study is to use an in-line force probe to determine the granulation end point of a high shear wet granulation process in which the formulation is constant and varying wet massing time. Furthermore, this research provided an understanding of the granule growth mechanisms during the granulation process, revealing instances of granule formation stages such as wetting and nucleation, consolidation and breakage. In addition, 1st derivative of the force is used to characterise the high shear wet granulation process capturing the change of force during the entire process. The result shows that the force profile are reproducible at different wet massing time. The granule properties such as size distribution, density, and percentage of lumps generated at the end of the granulation process varies with changes in the granulation wet massing time. The granulation end point is 150 s of wet massing generates granules with the optimal properties to produce the desired tablet critical quality attribute such as tensile strength and solid fraction also yield the least percentage of lumps at the end of the high shear wet granulation process.