Comparative pharmacokinetics of 2 brands of cefuroxime following a single intramuscular injection
Irshaid, Y.M.; Rawashdeh, N.M.; Zghol, F.; Jalal, I.; Najib, N.M.
International Journal of Clinical Pharmacology and Therapeutics 33(5): 285-293
1995
ISSN/ISBN: 0946-1965 PMID: 7655768 Document Number: 445448
The pharmacokinetic parameters (AUC-0-8h, AUC-o- infin , C-max, t-max, t-1/2, K-e) 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 AUC-0- infin Maxil/AUC-0- infin Zinacef and C-max Maxil/C-max 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 C-max, t-max, AUC-0-8h and AUC-0- infin . The 2 products were also similar regarding t-1/2 and K-e. 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.