A Comparison of in-vitro Pharmacokinetics and Pharmacodynamics of Branded and Its Locally Produced Cefuroxime Sodium Against Staphylococcus and Escherichia Escherichia coli.

Purpose: To compare the in-vitro antibacterial effects of branded and its locally produced cefuroxime sodium against Staphylococcus ATCC29213, clinical strains of methicillin-sensitive Staphylococcus aureus (MSSA) 164342 and methicillin-sensitive coagulase-negative staphylococci (MSCNS) 117933, and Escherichia coli ATCC25922, and to provide a reference for their clinical use.

Methods: An in-vitro antibacterial susceptibility test, time-kill curve and pharmacokinetics and pharmacodynamics (PK/PD) modeling was used in the comparison.

Results: The minimum inhibitory concentrations (MIC) of the two types of cefuroxime sodium were identical against four bacterial strains; both types of cefuroxime sodium had MICs of 0.5 μg/mL, 8 μg/mL, 0.5 μg/mL, and 0.25 μg/mL against ATCC 29213, ATCC 25922, M164342 and MSCNS117933, respectively. There were no significant differences in the time-kill curves of the two forms against the four strains at three concentrations. At drug concentrations of 2×MIC and 4×MIC, the bacterial count of all the strains decreased from 6 log CFU/mL to around 4 log CFU/mL. The bactericidal efficacies of the two agents were generally similar in the pharmacokinetics model of simulated intravenous drug administration of 1 g q8h. Only the PD parameter of bactericidal rate (KR) for ATCC 29213 and the area difference between the drug bactericidal curve and the bacterial growth control curve (I_E) for ATCC25922 were statistically different. The KR and I_E of the locally produced form were 0.73±0.10 logCFU·h/mL and 83.73±12.69 logCFU·h/mL, respectively, while the KR and I_E of the branded form were 1.19±0.07 logCFU·h/mL and 104.02±16.28 logCFU·h/mL, respectively.

Conclusion: The in-vitro antibacterial effect of locally produced cefuroxime sodium against Staphylococci and E. coli is comparable to that of branded cefuroxime sodium.