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.
