Formulation and evaluation of Nateglinide dispersible tablet by direct compression method

Abstract

The study was carried to formulate and evaluate dispersible tablet dosage form obtaining Nateglinide. Nateglinide is a  drug for the treatment of  type 2 diabetes. The present study is an attempt to select best possible combination of diluents and disintegrates to formulate dispersible tablet of Nateglinide which disintegrates within few minutes thereby reducing the time of onset of action. Mannitol is selected as diluents, Sodium starch glycol ate, Cross-povidone, cross-carmellose sodium were selected as super disintegrates, citric acid and sodium bi carbonate is effervescent active ingredient in different concentrations. Aspartame used as a sweetening agent, Magnesium stearate as a Lubricant and glidant. Direct Compression method was used to formulate the tablets. All the formulations were showed the acceptable flow properties and the pre-compression parameters like Bulk density, Tapped density and Hausner ratio. The post-compression parameters like Hardness, Friability, Disintegration time, Weight variation, wetting time, Dispersion time values were found to be within the IP limits. The percentage Drug content of all tablets was found to be between 99% - 100 % of Nateglinide, which is within the limit. As the concentrations of the Citric acid (preservative) and sodium bicarbonate (active ingredient respectively taking increases in the formulations F7 F9 the disintegration time found to be decreased and the disintegration time for these formulations were 33, 31, 30 seconds respectively and the percentage drug release was also found to be increased for these formulations as 94,96, and 99 % respectively. From the above results it was found that as the concentration of citric acid decreased and sodium bicarbonate increases the disintegration and dissolution time was found to be improved, so considering the above results it was found that the F9 batch was found to be optimized batch and it pass all the pre-formulation evaluation results as per the IP limits.