Formulation Optimization and Evaluation of Taste Masked Oro-dispersible Tablet of Levocetrizine Dihydrochloride by Ion Exchange Resin

The aim of this study was to prepare ODT of taste masked levocetrizine dihydrochloride by using ion exchange resin. Levocetrizine Dihydrochloride is bitter in taste, Kyron T-134 a weak cationic exchange resin was used to mask the bitter taste of the drug. The ODTs were prepared by using drug-resin (DRC) complex using batch process. Compression of ODTs was done by using direct compression method with the technique of addition of superdisintegrants. Central composite design (CCD) was applied as an optimization technique. FTIR and DSC studies indicated drug and excipients were compatible with each other. The prepared orodispersible tablet blend and tablets were evaluated for various pre-compression and post-compression parameters. The Batch LH3 was given as optimized batch by central composite design. This optimized batch LH3 was passed all the pre-compression and post- compression parameters. The prepared ODTS showed successfully rapid onset of action with decrease in disintegration time 26 sec and %drug released was found to be 98.26%. It was concluded that levocetrizine dihydrochloride ODTs were prepared successfully by taste masking method using Kyron T-134 ion exchange resin and croscarmellose sodium as Superdisintegrant using CCD. AS per CDER guidelines, it shows DT within 5-30 sec.