Content uniformity and dissolution characteristics of prednisolone Avicel PH 200 interactive powder mixture: a comparative study with Emcompress and lactose granules

Prednisolone interactive powder mixtures were prepared using Avicel(R) PH 2 00 as directly compressible microcrystalline cellulose and compared with si milar mixtures prepared using Emcompress(R), a grade of dibasic calcium pho sphate dihydrate and lactose granules. Content uniformity (CU) was evaluate d using USP XXIII criteria and non-parametric Lilliefors test on 30 samples . Dissolution efficiencies at 5 minutes (DE5) were determined in different media namely, water, 0.1N HCl and phosphate buffer of pH 6.8 at different s peeds, 50, 100 and 200 rpm. Tablets were evaluated for C.U. and found fulfi lling USP criteria, however they did not fulfill normal distribution criter ia of Lilliefors test at P = 0.05 due to mixing problems. Although Avicel i s an insoluble excipient, its powder mixtures produced DE5 values comparabl e to Lactose powder mixtures. These values were consistent in different dis solution media, an advantage for its use in formulations designed to be rel eased through out the G.I.T. A characteristic which was found lacking the p owder mixtures prepared using Emcompress.