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Comparative Study
. 2010 Jan 29:10:3.
doi: 10.1186/1472-6904-10-3.

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products for intravenous administration

Edelberto Silva #  1 , Jorge A Díaz #  1 , María J Arias  1 , Angela P Hernández  1 , Andrés de la Torre  1
Affiliations
Comparative Study

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products for intravenous administration

Edelberto Silva et al. BMC Clin Pharmacol. .

Abstract

Background: The antimicrobial resistance is a global problem, probably due to the indiscriminate and irrational use of antibiotics, prescriptions for incorrect medicines or incorrect determinations of dose, route and/or duration. Another consideration is the uncertainty of patients receiving antibiotics about whether the quality of a generic medicine is equal to, greater than or less than its equivalent brand-name drug. The antibiotics behaviors must be evaluated in vitro and in vivo in order to confirm their suitability for therapeutic use.

Methods: The antimicrobial activities of Meropenem and Piperacillin/Tazobactam were studied by microbiological assays to determine their potencies (content), minimal inhibitory concentrations (MICs), critical concentrations and capacity to produce spontaneous drug-resistant mutants.

Results: With respect to potency (content) all the products fulfill USP requirements, so they should all be considered pharmaceutical equivalents. The MIC values of the samples evaluated (trade marks and generics) were the same for each strain tested, indicating that all products behaved similarly. The critical concentration values were very similar for all samples, and the ratios between the critical concentration of the standard and those of each sample were similar to the ratios of their specific antibiotic contents. Overall, therefore, the results showed no significant differences among samples. Finally, the production of spontaneous mutants did not differ significantly among the samples evaluated.

Conclusions: All the samples are pharmaceutical equivalents and the products can be used in antimicrobial therapy.

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Figures

Figure 1
Figure 1
Bioassay of Meropenem (USP standard) against (A) Bacillus subtilis ATCC 6633, (B) Escherichia coli ATCC 10536, (C) Klebsiella pneumoniae ATCC 10031, (D) Micrococcus luteus ATCC 9341, (E) Pseudomonas aeruginosa ATCC 25619 and (F) Staphylococcus aureus ATCC 29737.
Figure 2
Figure 2
Bioassay of Piperacillin (USP standard)/Tazobactam against (A) Bacillus subtilis ATCC 6633, (B) Klebsiella pneumoniae ATCC 10031, (C) Micrococcus luteus ATCC 9341, (D) Pseudomonas aeruginosa ATCC 25619, (E) Staphylococcus aureus ATCC 29737 and (F) Streptococcus faecalis. Cited on page 6.
Figure 3
Figure 3
Calibration curve of ten concentrations of Meropenem to determine the optimal test range.
Figure 4
Figure 4
Calibration curve with 10 concentration levels of Piperacillin/Tazobactam to determine the optimal test range.
Figure 5
Figure 5
MIC and MLC assay for Piperacillin/Tazobactam.
Figure 6
Figure 6
Zones of growth inhibition produced by Meropenem against (A) K. pneumoniae ATCC 10031, (B) K. pneumoniae 65, (C) P. aeruginosa 151, and (D) A. baumanii 147.
Figure 7
Figure 7
Determination of critical concentration of Piperacillin/Tazobactam against E. gallinarum.
Figure 8
Figure 8
Diffusion gel assay testing the production of spontaneous Meropenem-resistant mutants, with A. baumanii 147 as a control strain and K. pneumoniae 63 as a mutant-producing strain.
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