Formulation Development of Tramadol Hydrochloride Rapid-disintegrating Tablets Using Simplex Lattice Design

Abstract

The effect of a mixture of super disintegrants on the disintegration time and in vitro drug release rate was studied. In this study, an attempt had been made to prepare rapid disintegrating tablets of the drug using different super disintegrants following wet granulation method. The sodium starch glycolate, cross carmellose sodium and pregelatinized starch (Starch 1500 ® ) were used in different concentration according to the simplex lattice design as the super disintegrants. The tablets were evaluated for diameter, thickness, hardness, friability, weight variation, wetting time, percentage of water absorption, disintegration time and in vitro dissolution studies. The disintegration time of all formulation showed less than 75 seconds. The formulation F4 showed low disintegration time that is 14 seconds and the percentage drug release was 97.33 within 10 minutes. The tablets containing equal quantity of Starch 1500 ® and cross carmellose sodium showed lowest disintegration time than other formulation containing Starch 1500 ® , cross carmellose sodium and sodium starch glycolate in various proportions shown in Table-1.