Design, Optimization, and In Vitro Characterization of Fast-Dissolving Tablets of Nifedipine Using Response Surface Methodology

The study focused on developing fast-dissolving tablets (FDTs) of nifedipine, a poorly water-soluble antihypertensive agent, using a spray-drying approach and response surface methodology for optimization. The optimized tablets demonstrated rapid disintegration in less than 120 seconds, reduced wetting time, and enhanced dissolution profiles. The solubility of nifedipine was significantly improved in ethanol compared to aqueous media. The design of experiments (DoE) models indicated statistically significant effects of formulation variables on the tablets' performance. Solid-state studies confirmed the compatibility of the drug with excipients. Overall, the study successfully developed nifedipine FDTs with improved in vitro performance, suggesting their potential for better oral delivery.