Abstract
Author(s): Kate RohiniHarikrushna
The primary aim of present work was to formulate and evaluate taste masked dispersible tablets of Cephalexin monohydrate, an antibacterial drug, using ion exchange resins like INDION 224 and ion exchange fibres Smopex 101pp as a taste masking agent and superdisintegrating agents like crospovidone and sodium starch glycolate in different concentrations. Characterization of drug was done by melting point determination, FT-IR spectroscopy and UV-spectroscopy. Drug-resin and fibre complexes were prepared by batch method using the resins and fibre in different ratios. Drug loading study was carried at different pH. INDION 224 and Smopex 101pp showed highest drug loading (86.44% and 90.41% ). Hence, further studies were done using INDION 224 and Smopex 101pp. The drug-resin/fibre complexes were studied for micromeritic properties, in vitrodrug release and taste masking ability by determining threshold bitterness concentration of the drug. The complexes were characterized by drug content, FTIR and DSC studies. Powder blends were prepared and evaluated for various physical properties. Dispersible tablets of drug-resin complex (DRC) and Drug-fibre complex (DFC) were prepared by Direct Compression method using crospovidone and sodium starch glycolate in different concentrations as superdisintegrants. Tablets were evaluated for thickness, hardness, friability, uniformity of weight, dispersion time, uniformity of dispersion, disintegration time, wetting time, wetting volume, content of active ingredient and dissolution studies. All the formulations showed the evaluated parameters within the acceptable limits for dispersible tablets. Finally, formulation F4 was taken as an optimized formulation which was containing 3% of crospovidone and showed the least in vitrodisintegration time and an excellent drug release. Stability study was also conducted on the optimized batch F4 which showed good results.