1Department of Pharmaceutics, Parul Institute of Pharmacy, Faculty of Pharmacy, Parul University, Waghodia, Vadodara, 391760, Gujarat, India
2Formulation Research and Development Orals, Sun Pharmaceuticals Industries Limited
3Department of Pharmaceutical Analysis and Chemistry, Indukaka Ipcowala College of Pharmacy, The Charutar Vidya Mandal University, New V. V. Nagar, Anand, 388 121, Gujarat, India
Background: Hypertension affects over 1.13 billion people globally and requires consistent blood pressure control to prevent cardiovascular complications. Conventional immediate-release formulations of metoprolol tartrate necessitate multiple daily doses due to its short half-life (3-7 hours), leading to poor patient compliance and fluctuating plasma concentrations.
Objective: To develop and optimize a controlled-release elementary osmotic pump (EOP) tablet of metoprolol tartrate providing sustained 24-hour drug release for improved hypertension management.
Methods: EOP tablets were formulated using wet granulation technique with metoprolol tartrate (100 mg) as the active ingredient, sodium chloride and mannitol as osmogens, and cellulose acetate as the semipermeable membrane. A 3² full factorial design was employed to optimize osmogen amount (10-20 mg) and coating weight gain (4-8%). Drug release was evaluated using USP dissolution apparatus in phosphate buffer for 24 hours. Release kinetics were analyzed using zero-order, first-order, Higuchi, and Korsmeyer-Peppas models.
Results: The optimized formulation demonstrated 93.8% cumulative drug release over 24 hours with 22.5% release at 2 hours, following zero-order kinetics (R² = 0.9937). Scanning electron microscopy confirmed an orifice diameter of 0.585 μm. Stability studies at 25°C/60% RH and 40°C/75% RH for 30 days showed minimal degradation with 89.94% and 87.54% drug release respectively.
Conclusion: The developed EOP system successfully achieved controlled metoprolol tartrate release over 24 hours, offering a promising approach for once-daily hypertension therapy with improved patient compliance and consistent therapeutic outcomes.
Keywords: Elementary osmotic pump, Metoprolol tartrate, Controlled release, Zero-order kinetics, Hypertension management, Design of experiments.
How to cite this article: Rede P, Pandya A, Kuril V, Sompura K, Bhatt J, Patel L. Development and Optimization of Elementary Osmotic Pump Tablets of Metoprolol Tartrate for Enhanced Hypertension Management: A Systematic Approach Using Design of Experiments. Int J Drug Deliv Technol. 2026;16(16s): 306-321. DOI: 10.25258/ijddt.16.16s.34
Source of support: Nil.
Conflict of interest: None