Vikas Kumar Sahu

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.

The aim of the current research is to prepare and test sustained-release (SR) tablets of Metformin hydrochloride using hydrophilic polymers such as Hydroxypropyl Methylcellulose (HPMC), Xanthan gum and Eudragit RSPO so as to attain sustained glycemic control in diabetic animal models. The wet granulation method is used to prepare tablets and the physicochemical properties such as weight variation, hardness, friability, thickness and uniformity of drug content are determined and all are found to be within acceptable limits. In vitro drug release showed a release of Metformin is controlled over 12 hours with release kinetics consistent with the Korsmeyer-Peppas model, reflecting diffusion and erosion. Sustained drug absorption is observed in streptozotocin-induced diabetic Wistar rats in which in vivo pharmacokinetic analysis of the SR formulations demonstrated a long Tmax and half-life (t1/2) and higher area under the plasma concentration-time curve (AUC) than immediate-release Metformin. One-way ANOVA and Tukey post-hoc statistical analysis showed that there are significant differences between formulations (p