BIOAVAILABILITY OF CEFUROXIME AXETIL FORMULATIONS

Cefuroxime axetil tablets have proved effective for the treatment of a variety of community-acquired infections. A suspension formulation ha s been developed for use in children. Two studies have been conducted to determine if the cefuroxime axetil formulations are bioequivalent. In the initial randomized, two-period crossover study, 24 healthy men received 250-mg doses of suspension and tablet formulations of cefurox ime axetil every 12 h after eating for seven doses. Each treatment per iod was separated by 4 days. Comparisons of serum and urine pharmacoki netic parameters indicated that the suspension and tablet formulations of cefuroxime axetil are not bioequivalent. Following the initial bio equivalency study, 0.1% sodium lauryl sulfate (SLS) was added to the s uspension to assure the homogeneity of the granules during the manufac turing process. In the subsequent randomized, three-period crossover s tudy, 24 healthy men received single 250-mg doses of three cefuroxime axetil formulations: suspension without SLS, suspension with SLS, and tablet. Again each treatment period was separated by 4 days. Pharmacok inetic analyses demonstrated that while the suspension with SLS and su spension without SLS are bioequivalent, bioequivalence between the sus pension with SLS and the tablet was not observed. Thus, the addition o f the SLS surfactant to the suspension did not alter the bioavailabili ty of the formulation.