Bioavailability and Bioequivalence of Two Formulations of Etodolac (Tablets and Suppositories)

Abstract

We studied the influence of administration route on the biopharmaceutical behavior of etodolac. The levels obtained in plasma when the same dose of etodolac Is administered orally (tablets, dosage form A) and rectally (suppositories, dosage form B) were compared. The study was done in a crossover design with healthy volunteers of both sexes, of average build, and younger than 35 years of age. From the concentration in plasma-time data, the maximum concentration in plasma (Cmax), time to Cmax, and area under the curve up to the last measurable concentration (AUC•>) or infinity (AUCo) were calculated and compared by analysis of variance. With the exception of Cmax, no significant differences between treatments were found in the rest of the parameters. Finally, with formulation A (tablets) as a reference, the relative bioavailability was established, on the basis of the ratio (B:A) of AUCQ and AUC•, within the range 100 ± 20%. The results Indicate that the two routes of administration are bioequivalent and that the rectal route is an alternative administration route for etodolac.