FORMULATION AND CHARACTERIZATION OF GLIMEPIRIDE CYCLODEXTRIN COMPLEX-BASED FUSIBLE TABLETS"

Glimepiride is a widely used oral hypoglycemic agent, but its poor aqueous solubility results in low bioavailability and variable therapeutic outcomes in type 2 diabetes treatment. This study aimed to enhance its solubility and dissolution profile by formulating and characterizing glimepiride–cyclodextrin inclusion complexes. β-Cyclodextrin (β-CD) and hydroxypropyl-β-cyclodextrin (HP-β-CD) were employed to prepare inclusion complexes using physical mixing, kneading, and co-precipitation techniques. The resulting complexes were then formulated into rapidly disintegrating tablets incorporating superdisintegrants via direct compression. Phase solubility studies confirmed 1:1 molar ratio complex formation with significant solubility enhancement. FT-IR and DSC analyses verified successful complexation, while tablet evaluation demonstrated acceptable hardness, friability, and drug content. In vitro dissolution studies showed that tablets containing HP-β-CD complexes exhibited significantly improved drug release compared with marketed formulations. Furthermore, accelerated stability testing confirmed preservation of formulation performance over six weeks. Overall, these results suggest that rapidly disintegrating tablets based on glimepiride–cyclodextrin inclusion complexes represent a promising strategy for improving the oral delivery and therapeutic efficacy of glimepiride in type 2 diabetes management.