The present work was to design and evaluation of mouth dissolving tablets of Cetirizine hydrochloride by using superdisintegrants. A novel approach has been made to develop Cetirizine hydrochloride mouth dissolving tablets by including clove oil as flavor and local anesthetic on taste buds. The drug and excipients were characterized using Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared (FTIR) techniques. The drug excipient blend was evaluated for examined physicochemical properties. The prepared tablets were evaluated for thickness, hardness, friability, mouth feel, wetting time, content uniformity, in vitro disintegration time, in vivo disintegration time and in vitro dissolution studies. Formulation (F-4) showed quick disintegrating time of 228.26 s, which is very characteristic of mouth dissolving tablets. Further optimized formulations (F-4 and F-5) were subjected to accelerated stability studies for 3 months at temperature 40±5ºC/75±5%RH. The tested tablets did not show any changes with respect to taste, disintegration and dissolution profiles. In conclusion, the results of this work suggest the inclusion of Clove oil (which has both flavoring and local anesthetic actions), which reduces the processing charges and use of costlier taste masking agents.
Keywords: Mouth dissolving tablet, Cetirizine hydrochloride, Clove oil, superdisintegrants.