Comparison of serum indomethacin profiles after rectal administration of two brands of indomethacin suppositories in healthy volunteer subjects

Abstract

Previous in vitro dissolution data indicated a much slower release of indomethacin from Indocid suppositories than from Imbrilon suppositories; both products contain 100 mg of indomethacin. Since in vitro findings require in vivo validation before clinical recommendations can be made, the present study was designed to compare the in vivo release characteristics of the two products. The study was carried out in 12 volunteer subjects in a fully randomized double-blind cross-over fashion and involved administration of Indocid and Imbrilon suppositories at bedtime. Venous blood samples were obtained over the first 12 h post-drug administration, while pooled urine was collected from 0–12 and 12–24 h. Indomethacin content of all samples were measured using HPLC. The experimental data were compared using the following parameters: T max, C pmax and all other timed plasma concentrations, AUC 0–12h and cumulative urinary excretion data from 0–12, 12–24 and 0–24 h. Statistical analyses, using the paired t-test, indicated that no statistically significant differences ( P > 0.05) occurred between any of the measured parameters for the two products. It is therefore unlikely that clinically significant differences between the two products will be seen during treatment in patients.