Content uniformity and dissolution characteristics of prednisolone Avicel PH 200 interactive powder mixture: a comparative study with Emcompress and lactose granules
E. Khalil et A. Sallam, Content uniformity and dissolution characteristics of prednisolone Avicel PH 200 interactive powder mixture: a comparative study with Emcompress and lactose granules, STP PHARM S, 10(2), 2000, pp. 149-155
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.