COMPARATIVE PHARMACOKINETICS OF 2 BRANDS OF CEFUROXIME FOLLOWING A SINGLE INTRAMUSCULAR INJECTION

The pharmacokinetic parameters (AUC(0-8h), AUC(0-infinity), C-max, t(m ax), t(1/2), K-e) of cefuroxime following a single intramuscular injec tion of 750 mg of a test product (Maxil, Hikma Pharmaceuticals, Amman, Jordan) were compared to those of a reference product (Zinacef, Glare , UK). The 2 products were administered according to a randomized 2-wa y crossover design to 26 healthy male volunteers. Cefuroxime plasma co ncentrations were determined using a rapid, sensitive and precise HPLC method with UV detection at 280 nm. The means of the ratios AUC(0-inf inity), Maxil/AUC(0-infinity) Zinacef and C-max Maxil/C-max Zinacef we re close to 1 and their 900/0 confidence intervals included 1. The mea n pharmacokinetic parameters of the 2 products were not different and their 90% confidence intervals overlapped. The 2 products were not sta tistically different with respect to both rate and extent of absorptio n as demonstrated by statistical analysis on C-max, t(max), AUC(0-8h) and AUC(0-infinity). The 2 products were also similar regarding t(1/2) and K-e. The ANOVA analysis showed no differences in the pharmacokine tic parameters of the 2 products in relation to treatment, sequence of product administration or the interaction term. Pharmacokinetic param eters of cefuroxime were comparable to reported values. We conclude th at the 2 products of cefuroxime (Maxil and Zinacef) are bioequivalent.