Evaluation of Process Analytical Technology (PAT) in Monitoring Granulation Parameters for Improved Tablet Uniformity.

Therapeutic efficacy and safety of pharmaceutical tablets largely depend on their uniformity and quality, especially during preclinical studies. This study will assess the use of Process Analytical Technology (PAT) to monitor granulation parameters in real time to enhance the consistency of tablets. During wet granulation, properties of the granules including particle size, moisture content, and bulk density are continuously measured using near-infrared spectroscopy (NIRS) and in-line particle size analyzers using animal-model-compatible formulations. GRS PAT granules are converted into tablets and examined concerning mass homogeneity, firmness, and friability and compared with non-PAT batches. Findings indicated that PAT-controlled production has led to a large decrease in the batch-to-batch variability resulting in tablets of uniform physical characteristics and mechanical strength. The statistical analysis revealed that batches approached by PAT is superior to conventional processes. The results indicate that the use of PAT in preclinical preparations improves process controls, variability, and stable tablet quality, which is a key to its usability as a standard method in early pharmaceutical development.