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Abstract

The present research aimed to design, produce, and assess Amlodipine-loaded medicated gummies as a patient-friendly dosage form to improve compliance, especially in pediatric and geriatric patients with hypertension. Amlodipine was integrated into gelatin- and pectin-based gummy matrices utilizing sucrose, corn syrup, citric acid, glycerol, and flavoring ingredients to formulate six optimal batches. The formulated gummies were assessed for physical appearance, weight uniformity, pH, moisture content, water activity, texture hardness, drug content uniformity, spreadability, syneresis, and in vitro drug release. FTIR analyses demonstrated the absence of notable drug-excipient interactions. All formulations had a smooth appearance, satisfactory flavor and texture, and uniform medication distribution. The formulations exhibited an appropriate pH range, moisture content within acceptable levels, and water activity below thresholds that pose microbiological risks. The hardness ratings demonstrated sufficient chewability. The in-vitro release research demonstrated quick disintegration, with over 85% drug release occurring within 30 minutes, so validating its appropriateness for immediate-release delivery. The modified formulation exhibited enhanced mechanical qualities, ideal organoleptic traits, and the most favorable release kinetics across all batches. Amlodipine gummies were effectively created and characterized, indicating their promise as a convenient, pleasant, and efficacious oral dose form to enhance therapeutic compliance. 

Keywords

Amlodipine, Gummy, Agar, Gellan gum, Calcium lactate pentahydrate Hypertension.

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