Abstract

Hydroxyzine hydrochloride is a histamine H1 receptor antagonist used in the treatment for chronic urticaria, dermatitis, and histamine-mediated pruritus. Hydroxyzine hydrochloride has a bitter taste. The bitter taste of drug was masked by using a combination of flavor and complexing with β-cyclodextrines adopting solid dispersion technique. The taste masking ability of solid dispersions was evaluated by in vivo taste evaluation in healthy human volunteers. The Optimized taste masked solid dispersion of drug was developed as fast dissolving tablets by direct compression method using superdisintegrants like sodium starch glycolate, croscarmellose sodium and crospovidone in different concentration as per 2³ factorial design model. Tablets were evaluated for their physico-chemical properties, in vitro release studies. The hardness (3.8-4.2 kg/cm²), friability (0.22 %-0.43 %), drug content (91.7 %-99.5 %) and disintegration time (3.24-4.22 min) of fast dissolving tablets were found uniform and within the specified limits. Analysis of variance was used to identify significant effect on disintegration time, Coefficient of determination R²=0.995. Obtained value of F was larger than critical F-value, and the result was found to be significant at that level of probability (p<0.05). Similar R²=0.9023 value was obtained in case of dissolution rate for F value and the result was found to be significant at that level of probability (p<0.05). From the statistical results, optimized formula F9 was developed which gave disintegration time of 3.58±0.87 min and in vitro drug release of 95.89 %. The formulations followed first order mechanism of release (r²=0.953-0.991). Hence taste masked Hydroxyzine hydrochloride fast dissolving tablets could be successfully developed using factorial design modele.