Cefixime; disposition kinetics and bioavailability comparison of two formulations of cefixime in healthy adult male subjects

ABSTRACT

Cefixime is a third generation and orally acting cephalosporin. It is a cell wall synthesis inhibitor and is well stable to presence of beta lactamase enzymes. Environmental and genetic differences play a greater role in disposition kinetics of a drug. To determine disposition kinetics of cefixime in local population and to evaluate the bioequivalence of multinational and national brands of cefixime. 2013-2014. Institute of Pharmacy, Physiology and Pharmacology, University of Agriculture, Faisalabad. In present study disposition kinetics and bioequivalence of two brands of cefixime, cefspan and ceforal-3, were investigated in 10 adult healthy male subjects after a single oral dose of 400 mg capsule of each with a 7 days washout period. After blood sampling, plasma concentration of cefixime was determined by HPLC method. For computing disposition kinetic parameters, one compartment open model was applied. Mean values of disposition kinetic parameters; t1/2 Beta 5.01 and 4.72 hours, Vd 1.10 and 1.29 L/kg and CI[B] 0.16 and 0.21 L/hr/kg of cefspan and ceforal-3, respectively, were found non significantly [P 0.05] different. Similarly mean values of bioavailability parameters; AUC 36.58 and 32.99microg.hr/mL, AUMC 282.95 and 264.13 microL/g.hr[2]/mL and MRT 7.79 and 7.83 hours of cefspan and ceforal-3, respectively, remained non significantly [P > 0.05] different. All the parameters were compared by paired t-test. Relative bioavailability was found to be within the range 80-125% which is acceptable for bioequivalence. The test formulation, ceforal-3, was found bioequivalent to the reference formulation, cefspan