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.
Irshaid
Y M
YM
Department of Pharmacology, Faculty of Medicine, University of Science and Technology, Irbid, Jordan.
Rawashdeh
N M
NM
Zghol
F
F
Jalal
I
I
Najib
N M
NM
D000328:Adult; D000704:Analysis of Variance; D001682:Biological Availability; D002444:Cefuroxime / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D003198:Computer Simulation; D018592:Cross-Over Studies; D015507:Drugs, Investigational; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D012015:Reference Standards; D013810:Therapeutic Equivalency
D015507:Drugs, Investigational; D002444:Cefuroxime