Evaluation of Complexed Starch-Urea-Citrate as A Novel Super Disintegrant

Abstract

The present investigation deals with the synthesis of starch-urea-citrate complex polymer by gelatinizing starch slurry with urea and citric acid. The formed starch-urea-citrate (SUC) polymer was found to be colorless and free flowing powder. Fast disintegrating tablets of ofloxacin were prepared using different concentrations of starch-urea-citrate (7.5-30% w/w of tablet) and evaluated for both pre and post compression studies. The results of granular micromeritic properties like bulk density, angle of repose, Carr’s index and hausner’s ratio showed that all the formulations possessed good flow properties, uniformity and compressibility. The complexation of SUC synthesis and also the compatibility between ofloxacin and the polymer were confirmed by IR spectroscopy. The compressed tablets showed good hardness (3.5-4kg/cm2) and friability values < 0.5% with uniformity in drug content within the range of 99.2 to 100.2 %. The disintegration time of all the formulations was less than one minute. From the results, it was observed that with increments in starch-urea-citrate concentration in the formulations, there was a decrease in the values of wetting time and the disintegration time. The optimized formulation showed a complete in-vitro drug release within 40 min. as compared to the commercial product. Thus it was made evident that the starch-urea-citrate could be used as an excellent super disintegrant.