QBD-DRIVEN DESIGN AND PHARMACOKINETIC PROFILING OF REMOGLIFLOZIN ETABONATE SUSTAINED-RELEASE MATRIX TABLETS FOR DIABETES MANAGEMENT

Objective: With an emphasis on type 2 diabetes treatment, this work applied a QbD-based framework to design and optimize sustained-release Remogliflozin etabonate tablets, intending to enhance therapeutic effectiveness and patient adherence for type 2 diabetes management. Methods: The study implemented a full factorial design to explore how Eudragit L100 and microcrystalline cellulose influence drug release and tablet hardness. The formulations were developed via direct compression and subjected to comprehensive evaluation, including pre-and post-compression properties, dissolution kinetics, compatibility, stability, and in vivo pharmacokinetic behavior in Wistar rats. Statistical analysis and formulation optimization were executed using Design Expert® software. Results: All formulations met pharmacopoeial quality standards. The optimized formulation (F5) demonstrated 99.26±0.65 % cumulative drug release within 10 h, with release kinetics best fitting the Korsmeyer-Peppas model with a correlation coefficient of R² = 0.9976, indicating anomalous diffusion. Pharmacokinetic studies revealed significantly lower Cmax (94.62±4.3 ng/ml vs. 127.51±6.1 ng/ml, p