EVALUATION OF PHARMACEUTICAL QUALITY OF PREDNISONE TABLETS FROM MULTINATIONAL MARKETS

This report describes results of a collaborative study in which sample s of the 5 mg strength of prednisone tablets were evaluated following a common protocol based on European (Ph. Eur.) and US Pharmacopeial (U SP) specifications. Several tests including, identification, content u niformity and dissolution were performed. Laboratories from 16 countri es submitted data representing 42 products obtained from the respectiv e local markets. There were no reported abnormalities in general appea rance and identification of the products evaluated. Most products met the requirements for assay and content uniformity. Dissolution results showed that 11 lots did not meet the USP S1 stage Tolerance Criterion , whereas products from Greece (one lot) and Sweden (two lots) would n ot meet the dissolution requirement of USP even at the S3 stage, i.e, these lots would be rejected. Overall variability (% CV) in percent dr ug release values at different sampling times for the tested products and those of USP calibrator tablets were not significantly different f rom each other. To assess the potential effect of dissolution characte ristics on in vivo bioavailability, the percent drug release values we re also evaluated using a logarithmic-probability regression approach as described in the literature. The results suggest that, except for t he products which would not meet USP criterion (S3 Stage), other teste d products would not be expected to have bioavailability problems.