FORMULATION AND EVALUATION OF MEDICATED LOLLIPOP USING CALCIUM CARBONATE

Calcium carbonate is a pharmacopoeially recognised pharmaceutical agent used in the management of calcium deficiency, hyperphosphataemia, and acid-peptic disorders. Conventional oral solid dosage forms such as tablets are associated with patient compliance challenges, particularly in paediatric and geriatric populations due to swallowing difficulties and poor palatability. Medicated lollipops represent a confectionery-based drug delivery approach that combines therapeutic dosing with improved palatability and patient acceptability. The present study aimed to formulate and evaluate medicated lollipops containing calcium carbonate (500 mg per unit) using a 3² full factorial design, with sucrose (X1) and dextrose (X2) as the two independent variables, each evaluated at three coded levels (-1, 0, +1). A total of nine batches (F1 to F9) were prepared by the heat-fusion moulding method. Each formulation was evaluated for physical appearance, weight variation (mean ± SD, n = 3), hardness (mean ± SD, n = 3), friability (mean ± SD, n = 3), drug content (complexometric titration, mean ± SD, n = 3), in vitro dissolution in 0.1 N HCl (pH 1.2) and phosphate buffer (pH 6.8) (mean ± SD, n = 3), pH (mean ± SD, n = 3), and taste evaluation (mean palatability score ± SD, n = 12 volunteers). The analytical method was validated for linearity, accuracy, precision, specificity, LOD, LOQ, and robustness. Among all formulations, batch F5 (sucrose 12 g, dextrose 3 g; coded level 0/0) demonstrated optimal performance: drug content 99.8 ± 0.36%, friability 0.51 ± 0.03%, hardness 6.2 ± 0.08 kg/cm², complete drug release 99.1 ± 1.2% at 30 minutes in 0.1 N HCl, and the highest palatability score of 4.7 ± 0.3 (5-point scale). ANOVA confirmed statistically significant main effects of both X1 (p < 0.05) and X2 (p < 0.05) on drug release and hardness, with no significant interaction effect. The formulation was stable under accelerated conditions (40°C/75% RH) for three months. These results confirm that medicated lollipops represent a viable and palatable oral delivery system for calcium carbonate, and that the 3² factorial design is an effective tool for candy base optimisation.