COMPARATIVE BIOAVAILABILITY OF 2 TABLET FORMULATIONS OF IBUPROFEN

This investigation was carried out to evaluate the bioavailability of a new tablet formulation of ibuprofen (600 mg), Profinal, relative to reference product, Brufen (600 mg) tablets. The 2 brands were found to be similar in assay, weight variation and dissolution as stipulated b y the USP XXII, as well as the disintegration time, as specified by th e BP 1988. The bioavailability was carried out on 18 healthy male volu nteers who received a single dose (600 mg) of the test (T) and the ref erence (R) products in the fasting state, in a randomized balanced 2-w ay crossover design. After dosing, serial blood samples were collected for a period of 12 hours. Plasma harvested from blood was analyzed fo r ibuprofen by a sensitive and validated high-performance liquid chrom atographic assay. The maximum plasma concentration (C-max), area under the plasma concentration-curve up to the last measurable concentratio n (AUC(0-t)), and to infinity (AUC(0-infinity)) were analyzed statisti cally under the assumption of a multiplicative model. The time to maxi mum concentration (T-max) was analyzed assuming an additive model. The parametric confidence intervals (90%) of the mean values of the pharm acokinetic characteristics (AUC(0-t)), (AUC(0-infinity)) and (C-max) f or T:R ratio were in each case, well within the bioequivalence accepta ble range of 80 - 125%. The test formulation was found bioequivalent t o the reference formulation by the Schuirmann's 2 1-sided t-tests and by Wilcoxon-Mann-Whitney 2 1-sided tests procedure. Therefore, the 2 f ormulations were considered to be bioequivalent.