Metformin Hydrochloride

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.

Floating Drug Delivery Systems (FDDS) offer a promising approach for enhancing the gastric retention time of orally administered drugs, especially those with a narrow absorption window in the upper gastrointestinal tract. This study aimed to formulate and evaluate FDDS tablets using different concentrations of hydrophilic polymers and gas-generating agents to ensure prolonged gastric residence and sustained drug release. Four formulations were prepared by direct compression and assessed for physical properties, buoyancy behavior, swelling index, drug content uniformity, and in vitro drug release over 12 hours. Among them, Formulation F4 demonstrated optimal performance, exhibiting the shortest floating lag time (25 seconds), longest floatation (>12 hours), highest swelling index (162%), and maximum cumulative drug release (96.7%). One-way ANOVA confirmed statistically significant differences in drug release and swelling index among the formulations (p