Advanced Formulation Development and Multi-Criteria Evaluation of Multivitamin Nutraceutical Lollipops for Enhanced Pediatric Adherence
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Abstract
The ongoing challenge with ensuring children adhere to prescribed medications is primarily due to developmental dysphagia and increased sensitivities to bitter-tasting pharmaceuticals. The aim of this project was to develop multivitamin nutraceutical lollipop formulations as a new method of delivery for pediatric patients. These formulations contained the following amounts per serving: 40mg Vitamin C, 1mg each of Vitamins B1 & B2, 1mg of Vitamin B6, and 2mcg of Vitamin B12, 5mg of Zinc Gluconate. A "sugar glass" matrix method of developing these dosages, using Quality by Design (Qbd) principles, provided a systematic means of examining the combined effects of sucrose and liquid glucose on the mechanical strength and disintegration properties of the final dosage forms. Through thermal degradation studies it was determined that the temperature at which all heat sensitive vitamins would begin to degrade is 85°C (with a range of 80 - 90°C). At or above this temperature, the amount of active ingredient remaining in the product will be >98.5%. The optimized sugar to glucose ratio of 2.3:1 in formulation F3 resulted in a solid with higher hardness values (5.8±0.15kg/cm²) than previously studied ratios, lower friability (0.51%), and a nearly linear zero order release pattern (R²=0.98) over a 25-minute period when exposed to simulated saliva (pH 6.8). The longer duration of disintegration is beneficial for both covering up the metallic flavor associated with the ingestion of zinc gluconate and possibly allowing for some degree of absorption through the buccal mucosa thereby reducing the first pass effect through the liver. Packaging requirements were established based upon accelerated stability tests conducted according to ICH Q1A(R2) guidelines (40°C/75%RH for 3 months), requiring high barrier moisture resistant packaging. Overall, the data demonstrates that nutraceutical lollipops are a novel, patient-centered format for providing important pediatric micronutrient supplementation, transforming what has historically been viewed as an unpleasant medical intervention into an enjoyable consumer experience.
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