Factorial Design Based Optimization of Hydroxyzine Hydrochloride Fast Dissolving Tablets

Abstract

Sarfaraza et al.: Fast dissolving tablets of Hydroxyzine hydrochloridesHydroxyzine 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 2 3 factorial design model. Tablets were evaluated for their physico-chemical properties, in vitro release studies. The hardness (3.8-4.2 kg/cm 2 ), 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 R 2 =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 R 2 =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 (r 2 =0.953-0.991). Hence taste masked Hydroxyzine hydrochloride fast dissolving tablets could be successfully developed using factorial design modele.

Untitled

“…One tablet was put in a Petri dish containing Whatman filter paper that had been soaked in 5mL of distilled water. The wetting time was recorded as the time taken for distilled water to reach the tablet's upper surface (Sarfaraz et al, 2020).…”

“…Six tablets from each formula were put in a disintegration tester (Erweka, GmbH, Germany). The average time needed for the tablets to disintegrate in distilled water at 37±0.5°C was recorded (Sarfaraz et al, 2020)..…”

“…After filtration and appropriate dilution, the quantity of drug in each sample was spectrophotometrically measured at 256 nm. To construct the drug release curves, the cumulative percent of the OM released was plotted against time (Sarfaraz et al, 2020).…”

Augmenting Bioactive Metabolite Synthesis from Streptomyces Species Isolated from Mangrove Sediments through Physio-Chemical Parameters

“…Mangrove actinobacteria are proficient to produce a set of enzymes which are highly stable even at higher temperature and alkaline environment [10] . An universal guideline used for the investigation of the moral and ethical value on the effects of operational parameters of a process by changing the value of only one factor at each time and recording the influence of that value on the final response [11] . The aim of the study includes improving the capability of bioactive metabolite synthesis by Streptomyces species by several physio-chemical parameters like pH, Temperature, Incubation time and sodium chloride concentration.…”