Formulation and Evaluation of Amlodipine-Loaded Natural Polymer-Based Chewable Gummies for Enhanced Patient Compliance and Controlled Release

Abstract

This study aimed to formulate and evaluate amlodipine-loaded natural polymer-based chewable gummies with controlled drug-release characteristics. Six formulations (F1–F6) containing Amlodipine equivalent to 5 mg amlodipine were prepared by the heating and congealing method using gelatin and sodium alginate. The gummies were evaluated for appearance, weight variation, surface pH, hardness, moisture content, drug content, swelling, syneresis, disintegration, in vitro drug release, release kinetics, and accelerated stability. Increasing polymer concentration increased hardness, swelling, and disintegration time while reducing syneresis and drug-release rate. Drug content ranged from 98.42 ± 5.12% to 100.24 ± 5.38%. F5 showed acceptable texture, hardness of 7.86 ± 0.58 N, drug content of 100.24 ± 5.38%, swelling index of 108.27 ± 8.46%, and 91.28% drug release at 8 h. Its release followed the Korsmeyer–Peppas model (R² = 0.9987; n = 0.7024). F5 remained physically and chemically acceptable during three months of accelerated storage. The gelatin–sodium alginate matrix therefore provided a feasible chewable platform for controlled amlodipine release.