Abstract
Indian Journal of Modern Research and Reviews, 2026; 4(8): 76-83
Development and Evaluation of Prolonged Release Carvedilol Matrix Tablets Using Hydrophilic–Hydrophobic Polymer Blends
Author Name: Alisha Banafar
Abstract
<p><strong>Objective:</strong> The present work was aimed at designing and optimizing a prolonged-release matrix tablet of carvedilol (12.5 mg) employing binary polymer combinations to achieve sustained antihypertensive and cardioprotective action over 24 hours and improve patient compliance through once-daily dosing.</p>
<p><strong>Methods:</strong> Nine formulations (F1–F9) were developed via wet granulation using varying proportions of hydroxypropyl methylcellulose (HPMC) K100M and ethyl cellulose (EC) N50 as rate-controlling polymers. Preformulation studies including Fourier-transform infrared (FTIR) spectroscopy were conducted to evaluate drug–excipient compatibility. The micromeritic properties of granules and physicomechanical characteristics of compressed tablets were assessed. <em>In vitro</em> drug release was performed in pH 6.8 phosphate buffer using a USP Type II dissolution apparatus at 37 ± 0.5 °C and 50 rpm. Dissolution kinetics were analyzed by zero-order, first-order, Higuchi, Korsmeyer–Peppas, and Hixson–Crowell models. Accelerated stability studies were conducted as per ICH Q1A(R2) guidelines.</p>
<p><strong>Results:</strong> Compatibility studies confirmed the absence of physicochemical interactions between carvedilol and the selected excipients. Among all developed batches, formulation F5, containing 20% w/w HPMC K100M and 5% w/w ethyl cellulose N50, exhibited the most desirable dissolution profile, releasing 95.5 ± 1.1 % of the drug over a 24-hour period. The release followed near-zero-order kinetics (R² = 0.981) with an anomalous (non-Fickian) transport mechanism (release exponent, <em>n</em> = 0.52; R² = 0.991). All formulations complied with pharmacopeial limits for weight variation, hardness, friability, and content uniformity. Accelerated stability testing (40 ± 2 °C / 75 ± 5 % RH, 90 days) demonstrated no significant change in drug content or release behaviour; the similarity factor (<em>f</em>₂) remained above 83.</p>
<p><strong>Conclusion:</strong> The optimized prolonged-release matrix tablet successfully sustained carvedilol release over 24 hours and displayed excellent physicochemical stability, presenting a viable platform for once-daily oral administration in the management of essential hypertension and chronic heart failure.</p>
Keywords
Carvedilol, Prolonged release, Matrix tablet, HPMC K100M, Ethyl cellulose N50, Release kinetics, Wet granulation, Hypertension.
