Formulation and In-Vitro Assessment of Alfuzosin Medicated Gummies as a Patient-Friendly Oral Dosage Form

Abstract

The study aimed to formulate and evaluate alfuzosin medicated gummies as a patient-friendly oral dosage form for long-term therapy of benign prostatic hyperplasia. Six formulations (F1–F6) containing 10 mg alfuzosin hydrochloride per gummy were prepared by the heating and congealing method using pectin and kappa-carrageenan as natural gelling polymers. The formulations were evaluated for appearance, weight variation, pH, hardness, moisture content, drug-content uniformity, swelling, syneresis, disintegration, in vitro drug release, release kinetics, and accelerated stability. Increasing polymer concentration increased hardness and disintegration time while reducing syneresis and drug-release rate. Drug content ranged from 97.84 ± 1.26% to 99.64 ± 0.96%. F5 showed acceptable texture, hardness of 14.16 ± 1.08 N, swelling index of 72.48 ± 5.64%, syneresis of 4.12 ± 0.33%, and 76.92% drug release at 120 min. Release predominantly followed first-order kinetics. F5 remained stable during three months at 40 ± 2°C/75 ± 5% RH. The pectin–kappa-carrageenan matrix therefore provided a suitable platform for alfuzosin medicated gummies.