Dissolution Rates of Commercial Phenylbutazone Tablets: Inter-And Intra-Brand Effects

Abstract

A study has been carried out to investigate the dissolution rate profiles of twelve batches of sugar-coated phenylbutazone tablets belonging to four commercial brands. Using the rotating basket method, significant inter-brand and inter-batch variations in dissolution rates were found. Only two batches of one brand passed the B.P. dissolution limit whilst other batches had percentages dissolution between 0.3 and 58 after 45 min. Batches with poor dissolution characteristics exhibited significant tablet-to-tablet variations in dissolution rates; a finding which was not observed in the relatively fast-dissolving batches. When the paddle method was substituted for the B.P. basket method, the dissolution rates were relatively faster but similar dissolution failure was found. However, the tablet-to-tablet dissolution variability was decreased in some of the batches. The observed differences in dissolution rates of the batches examined were unrelated to their disintegration times. Inspite of the poor dissolution characteristics of most of the batches studied, no apparent chemical degradation was found. It is recommended that when evaluating the dissolution rates of brands of phenylbutazone tablets, a number of batches from each brand should be tested.