Formulation and E-Tongue Evaluation of Taste-Masked Chewable Ferrous Ascorbate Tablets Using Design of Experiment.

Abstract

This study aims to develop and optimize taste-masked chewable iron tablets using Hydroxypropyl beta-cyclodextrin (HPßCD) and E-Tongue technology to improve patient compliance. A 2-level factorial design was employed to evaluate the effects of HPßCD, isomaltose, and Pearlitol® on the formulation. By using design of experiment the effect of each factor individually on the response can be predicted. There are 8 runs in this design the response for each 8 formulations is predicted individually by using design expert software. The composition of the tablet formulation was optimized using full factorial 23design, which is desirable for response surface methodology to optimize complex formulations. The results demonstrated favorable flow properties, with consistent bulk and tapped densities, and excellent mechanical strength, particularly for F8. In-vitro dissolution studies revealed a high cumulative drug release (93.75%) for F8. E-Tongue analysis indicated that F8 exhibited superior taste-masking efficiency, with the lowest bitterness score. The optimised chewable tablet evaluated for bitter score and hardness. According to point prediction mean predicted was found to be 4.1 for bitter score and observed mean was 4 and for hardness the predicted mean was 13kg/density and observed mean was 14 kg/density. Therefore, the optimised formulation F9 was Drug:CD (1:5), Sweetening agent (11.25mg) and Pearlitol (90 mg) Additionally, chewability was influenced by tablet hardness, with F8 showing the highest chewability difficulty index. The optimized formulation (F8) provides a balanced combination of taste masking, drug release, and mechanical strength, enhancing patient adherence.