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

MUSKAN A. KHAN; SACHIN B. SOMWANSHI; KAVERI T. VADITAKE; KIRAN B. KOTADE

doi:10.22159/ijap.2026v18i1.56445

Authors

MUSKAN A. KHAN Department of Pharmaceutics, Pravara Rural Education Society’s, College of Pharmacy (For Women), Chincholi-422102, Nashik, Maharashtra, India. Department of Pharmaceutics, JMCT Institute of Pharmacy, Nashik-422214, Maharashtra, India https://orcid.org/0009-0002-6277-7563
SACHIN B. SOMWANSHI Department of Pharmaceutics, Pravara Rural Education Society’s, College of Pharmacy (For Women), Chincholi-422102, Nashik, Maharashtra, India https://orcid.org/0000-0002-9131-6910
KAVERI T. VADITAKE Department of Pharmaceutical Chemistry, Pravara Rural Education Society’s, College of Pharmacy (For Women), Chincholi-422102, Nashik, Maharashtra, India https://orcid.org/0000-0002-9182-1159
KIRAN B. KOTADE Department of Pharmacology, Pravara Rural Education Society’s, College of Pharmacy (For Women), Chincholi-422102, Nashik, Maharashtra, India https://orcid.org/0000-0002-7066-2646

DOI:

https://doi.org/10.22159/ijap.2026v18i1.56445

Keywords:

Remogliflozin etabonate, Sustained-release matrix tablet, Quality by design, Pharmacokinetics, Eudragit L100, MCC

Abstract

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 C_max (94.62 ± 4.3 ng/mL vs. 127.51 ± 6.1 ng/mL, p < 0.01), prolonged T_max (5.84 ± 1.28 h vs. 1.99 ± 0.34 h, p < 0.001), and enhanced systemic exposure (AUC_₀–t: 2176.39 ± 48.13 vs. 1987.96 ± 37.24 ng h/mL, p < 0.05; AUC_₀–∞: 2598.81 ± 73.42 vs. 2263.35 ± 56.62 ng h/mL, p < 0.05). The half-life of the optimized SR-matrix tablets (7.64 ± 0.17 h) was significantly extended compared to the marketed reference tablet (5.93 ± 0.28 h, p < 0.05). Accelerated stability testing confirmed consistent physical and chemical attributes over 6 mo.

Conclusion: The QbD-driven approach successfully optimized RE SR-matrix tablets with robust sustained release behavior, improved pharmacokinetic performance, and satisfactory stability. These findings suggest the formulation as a promising strategy for sustained glycemic control and improved patient compliance in type 2 diabetes therapy.

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