September-October 2017 Indian Journal of Pharmaceutical Sciences 758 Research Paper Fast disintegrating tablet (FDT) dissolves or disintegrates in saliva within seconds when placed on the tongue before it is swallowed [1-5] . Unfortunately, cetirizine dihydrochloride (CTZ) has a very unpleasant bitter taste. Many strategies have been reported to decrease the bitter taste of CTZ. Some strategy is to use lipophilic Gelucire ® 33/01 in the presence of soybean lecithin to markedly reduce the bitterness without affecting CTZ release [6] . Besides, the effcient effect on masking CTZ bitterness, cyclodextrins (CD) as well could infuence the drug release from the formulation. The presence of β-cyclodextrin (β-CD) resulted in an increase of cetirizine release [7] . The inclusion complex between CTZ and β-CD prepared using a supercritical antisolvent (SAS) process and freeze drying method presented the same effcacy in regards to the dissolution characteristics [8] . CD and its derivatives were used as taste masking agents for the preparation of rapidly dissolving flms of CTZ by using a solvent casting method. The optimized ratio of 1:3 CTZ:hydroxypropyl β-CD was appropriate for taste masking [9,10] . CTZ was coated by a fuidized bed coating using Eudragit ® RL30-D and taste-masking evaluation was performed by healthy human volunteers and their perceived levels were recorded on a numerical scale [11,12] . Moreover, rizatriptan benzoate and β-CD prepared by kneading with distilled water demonstrated effective taste masking [13] . Therefore one of the methods of CD complexation is kneading method. Ethanol is widely used for wet granulation process in industry thus the kneading method with this solvent is effective and Cetirizine Dihydrochloride, β-Cyclodextrin Inclusion Complex by Ethanol Kneading for Taste Masking P. KATEWONGSA, N. LERTSUPHOTVANIT AND T. PHAECHAMUD* Department of Pharmaceutical Technology, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand Katewongsa, et al.: Cetirizine Dihydrochloride and β-Cyclodextrin Complex by Ethanol Kneading Cetirizine dihydrochloride has a very unpleasant bitter taste. To mask the bitter taste, complexation with β-cyclodextrin using ethanol as a kneading solvent was investigated and evaluated by Fourier transform infrared spectroscopy, differential scanning calorimetry, powder X-ray diffractometry, thermogravimetric analysis, simultaneous X-ray diffractometry-differential scanning calorimetry measurement and 1 H-nuclear magnetic resonance spectroscopy. Taste was evaluated by human volunteers using an unstructured line scale. The basic characterization of the prepared tablets including in vivo disintegration time and drug dissolution was studied. Fourier transform infrared spectroscopy, differential scanning calorimetry and powder X-ray diffractometry data confrmed the inclusion complex formation. Thermogravimetric analysis, simultaneous X-ray diffractometry-differential scanning calorimetry measurements revealed the reduction of crystalline β-cyclodextrin due to the displacement of water molecules from complex formation. Proton nuclear magnetic resonance spectroscopy indicated an intermolecular interaction between protons of cetirizine dihydrochloride with the cavity of β-cyclodextrin. The prepared complex showed an unstructured line scale with apparent low average rating of 1.70. The inclusion complex-loaded fast disintegrating tablet prepared with direct compression had short disintegration time and good taste with an unstructured line scale with average rating of 0.28. Cetirizine dihydrochloride, β-cyclodextrin inclusion complex was successfully prepared by kneading method using ethanol as solvent. The inclusion complex-loaded fast disintegrating tablet had good taste and good perception in the mouth. Key words: Cetirizine, β-cyclodextrin, inclusion complex, fast disintegrating tablet, ethanol kneading *Address for correspondence E-mail: thawatchaienator@gmail.com This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms Accepted 23 July 2017 Revised 15 February 2017 Received 14 October 2016 Indian J Pharm Sci 2017;79(5):758-767