Optimization of Melt-in-mouth Tablets of Levocetirizine Dihydrochloride Using Response Surface Methodology

The present research work was to design and develop an optimized melt-in-mouth tablet dosage form of an anti-allergic drug, Levocetirizine dihydrochloride by using sublimation technology. A total number of thirteen formulations were prepared as per the standard experimental design protocol using Design Expert Software (Version 7.1.6, StatEase Inc, Minneapolis, MN). Independent variables such as the amount of subliming agent –Camphor (X1) and the amount of superdisintegrantCrospovidone (X2) were optimized by application of 2-factor, 3-level Central Composite Design. The dependent variables selected were the disintegration time, wetting time, cumulative % drug release in 10 min. and water absorption ratio of the tablet. All the physical parameters of the melt-in-mouth tablets were practically within control. The mathematical relationships were generated using multiple linear regression analysis and all the polynomial equations were found to be statistically significant (P < 0.0002), as determined using ANOVA. The sublimation method used to prepare the melt-in-mouth tablets in this study is relatively simple and safe. A stable, effective and pleasant tasting mouth dissolving tablet, which has a good balance over disintegration time and mechanical strength, was formulated.