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Abstract

Managing oral drug administration in pediatrics faces significant compliance challenges due to the bitter taste of active pharmaceutical ingredients like ondansetron, which often leads to therapy rejection. This study designed, formulated, and evaluated a palatable, chocolate-based immediate-release oral delivery system to effectively mask drug bitterness and enhance patient adherence. Five distinct formulations (F1–F5) of ondansetron medicated chocolate were prepared by compounding uniform drug amounts (4 mg) with cocoa powder, milk powder, and sucrose syrup into a melted base containing varying concentrations of cocoa butter and lecithin powder. The resulting prepared formulations were thoroughly evaluated for physical appearance, weight variation, hardness, moisture content, disintegration time, and in-vitro drug release profiles. All batches exhibited a uniform dark brown color, smooth texture, pleasant odor, and zero blooming. The moisture content remained exceptionally low (<0.5%) across all formulations. Formulation F2, utilizing 0.47% moisture as a natural plasticizer, demonstrated superior quality with outstanding weight uniformity (0.31% RSD) and high mechanical strength (12.0 Kg/cm² hardness). Conversely, F3 failed standard weight variation criteria (9.00% RSD) due to poor pre-compression powder flowability. All formulations successfully passed immediate-release standards, completely disintegrating in under 6 minutes. Furthermore, in-vitro dissolution testing confirmed highly efficient profiles, with all five batches achieving 95% to 100% total drug release within 15 minutes. Formulation F2 was identified as the optimal candidate, successfully balancing excellent physical manufacturability, robust structural integrity for commercial shipping, and a rapid immediate drug release profile. Ultimately, medicated chocolate represents a highly promising, child-friendly delivery vehicle for masking bitter pediatric medications.

Keywords: Ondansetron, Chocolate, Pediatrics, Immediate-release, Dissolution

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