Pharmacokinetics and Bioequivalence of Cefixime in Healthy Male and Female Volunteers

Abstract

In present study pharmacokinetics and bioequivalence of two brands of cefixime i.e. Cefspan and Ceforal-3 were investigated in adult healthy female and male subjects. Plasma concentration of Cefixime was determined by HPLC method. Pharmacokinetic parameters were calculated following one compartment open model. The half life values were found 3.99±0.54 hr and 3.12±0.39 hr in local adult female subjects and 5.01±0.361 hr and 4.72±0.72 hr in healthy adult male subjects following administration of Cefspan and Ceforal-3, respectively. The values of Vd in local adult female and male volunteers were 1.38±0.22 l/kg and 1.10±0.15 l/kg, respectively, for Cefspan and 1.36±0.17 l/kg and 1.29±0.21 l/kg, respectively, for Ceforal-3. The values of ClB for Cefspan and Ceforal-3 were 0.27±0.02 l/hr/kg and 0.31±0.02 l/hr/kg, respectively, in local females and 0.16±0.02 l/hr/kg and 0.21±0.04 l/hr/kg, respectively, in local males. The values of Cmax were found 2.24±0.23 μg/ml and 2.08±0.16 μg/ml in local adult female subjects and 2.93±0.24 μg/ml and 2.53±0.31 μg/ml in healthy adult male subjects for cefspan and ceforal-3, respectively. The values of Tmax were 4.05±0.35 hr and 4.11±0.16 hr for cefspan and 3.87±0.32 hr and 3.95±0.26 hr for Ceforal-3 after oral administration in local adult female and male volunteers, respectively. The values of AUC for Cefspan and Ceforal -3 were 27.12±2.25 μg.hr/ml and 23.99±1.07 μg.hr/ml, respectively, in local females and 36.58±3.10 μg.hr/ml and 32.99±5.01 μg.hr/ml, respectively, in local males. In indigenous male and female human beings, pharmacokinetic and bioavailability parameters of cefixime showed different values than those reported in literature reflecting environmental and genetic influence. Pharmacokinetic and bioavailability parameters of cefixime also showed gender variation. Moreover both brands of cefixime used in present study were found bioequivalent in either gender.