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Author(s): Ahmed A. Elbary | Afaf A. Ramadan | Ihab R. Bendas | Dalia Abd Elaty Mostafa

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 2;
Issue: 9;
Start page: 58;
Date: 2011;
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Keywords: Rapid disintegrating tablets | Flupentixol dihydrochloride | ICH guidelines | superdisintegrating agents | mass extrusion.

The aim of the present study was to develop rapid disintegrating tablets of Flupentixol dihydrochloride, a slightly bitter antipsychatric drug. An attempt has been made to prepare bitterless rapid disintegrating tablet using Eudragit E100 as a taste masking agent. The tablet was prepared with three superdisintegrants e.g. sodium starch glycolate, crosscarmellose sodium and crospovidone , each one was added in three different concentration 2%, 3% and 4% ; mass extrusion was the technique used for the preparation of these tablets. The blend was examined for angle of repose, bulk density, tapped density, compressibility index and Hausner’s ratio. The compressed tablets were evaluated for hardness, drug content, friability, disintegration time in-vitro and in-vivo, wetting time and dissolution rate. The contents of the prepared tablets were characterized by X-ray diffraction and Fourier transform infrared spectroscopy (FTIR). Different nine formulas showed in-vitro disintegration times ranges from 11.8 sec to 61 sec , but it was 150 sec for F1 ( formula without any superdisintegrant). These results were nearly correlated with in vivo disintegration times for the ten formulas. In vitro dissolution studies showed the release in the following descending order of superdisintegrants: Crospovidone > Croscarmellose sodium > Sodium Starch Glycolate. Maximum in vitro dissolution rate was found to be with formulation F10 which contains crospovidone (4%). Thus, F10 was considered the best among the other formulations. The stability study was conducted as the International Conference on Harmonization (ICH) guidelines and the formulations subjected again for changes in hardness, friability, drug content, wetting time and disintegration time. Crospovidone at a concentration of 4% w/w is suitable for preparing rapid disintegrating tablet of Flupentixol dihydrocloride.
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