The shortage of child friendly formulations constitutes a key part of the major challenges impeding the successful management of tuberculosis disease in the paediatric population. Chewable formulations are an attractive alternative to traditional preparations like tablets and suspensions owing to the possibility for taste masking, administration without water, their unique physical appeal, visually appeasing shapes, and useability in children 2 years old and above. Consequently, we designed a polymeric gummy drug formulation (P-GDF), herein referred to as the FlexiChew formulation, containing a first-line antitubercular agent, isoniazid, using a combined solid-liquid dispersion and temperature dependent sol-gel processing technique. The resulting P-GDF was visually attractive, supple, easy to handle, dimensionally compact (17.738 ± 0.779 mm height, 10.473 ± 0.944 mm width, and 8.603 ± 0.852 mm thickness), light weight (1.425 ± 0.038 g), mechanically robust (hardness = 37.260 ± 4.66 N; resilience = 0.542 ± 0.029), and potentially easy to masticate (chewiness = 30.570 ± 13.090 N; cohesiveness = 0.800 ± 0.283%; adhesiveness = 0.018 ± 0.007 mJ). It was structurally intact, effectively encapsulated isoniazid (101.565 ± 4.181%), and released it (≈100% in 75 min) following zero order and non-Fickian mechanisms in different dissolution media. Besides, it displayed efficient taste masking and palatability relative to its placebo (signal distance = 54). Short-term stability studies revealed optimal storage conditions to be under controlled ambient environments, away from direct light, and without desiccants. Thus, a child friendly isoniazid-loaded edible gummy drug formulation was successfully fabricated with the goal of improving adherence and therapeutic efficacy.
Keywords: Chewable gel tablets; Design of experiments; Paediatric drug formulation; Polymeric drug delivery; Solid oral dosage form; Tuberculosis pharmacotherapy.
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