Factorial Design Based Optimisation of Metoclopramide Hydrochloride Fast Dissolving Tablets

Aim of the study The present investigation was aimed at developing taste masked fast dissolving tablets FDT of metoclopramide hydrochloride using 23 factorial design model.Materials and methods Metoclopramide hydrochloride is used as antiemetic drug and is intensely bitter in taste. The bitterness of drug was reduced by using a combination of flavour and complexing with beta-Cyclodextrins.The taste masking ability of complex was evaluated in healthy human volunteers. The taste masked fast dissolving tablet was developed by direct compression method using superdisintegrants like sodium starch glycolateSSG croscarmellose sodium CCS and crospovidone CP in different concentration as per 23 factorial design model.Results and conclusions The physico-chemical properties of tablets were evaluated prior to in vitro release studies. The hardness 4.7plusmn0.12 - 5.0plusmn0.20 kgcm2 friability 0.07plusmn0.22 - 0.83plusmn0.24 drug content 9.40plusmn0.36 - 10.46plusmn0.21 mg and disintegration time 8.24plusmn0.46 - 90.00plusmn0.70 sec of FDT were found uniform and acceptable as per limits. ANOVA was used to determine the significant effect. The model was found to be significant at the level of probability plt0.05 for disintegration time and also dissolution rate as well. From contour plots obtained the formula of optimized tablet was predicted. The optimised concentration of superdisintegrants was 15.6 mg of SSG 9.80 mg of CCS and 9.40 mg of CP. Optimised formula F9 gave disintegration time of 8.24plusmn0.46 sec and 99.262 of drug release. The formulations followed first order mechanism of release r20.793 ndash 0.926.