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.