Comparative pharmacokinetics of 2 brands of cefuroxime following a single intramuscular injection.

The pharmacokinetic parameters (AUC0-8h, AUC0-infinity, Cmax, tmax, t1/2, Ke) of cefuroxime following a single intramuscular injection of 750 mg of a test product (Maxil, Hikma Pharmaceuticals, Amman, Jordan) were compared to those of a reference product (Zinacef, Glaxo, UK). The 2 products were administered according to a randomized 2-way crossover design to 26 healthy male volunteers. Cefuroxime plasma concentrations were determined using a rapid, sensitive and precise HPLC method with UV detection at 280 nm. The means of the ratios AUC0-infinity Maxil/AUC0-infinity Zinacef and Cmax Maxil/Cmax Zinacef were close to 1 and their 90% confidence intervals included 1. The mean pharmacokinetic parameters of the 2 products were not different and their 90% confidence intervals overlapped. The 2 products were not statistically different with respect to both rate and extent of absorption as demonstrated by statistical analysis on Cmax, tmax, AUC0-8h and AUC0-infinity. The 2 products were also similar regarding t1/2 and Ke. The ANOVA analysis showed no differences in the pharmacokinetic parameters of the 2 products in relation to treatment, sequence of product administration or the interaction term. Pharmacokinetic parameters of cefuroxime were comparable to reported values. We conclude that the 2 products of cefuroxime (Maxil and Zinacef) are bioequivalent.