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. 2011 Jul 21:11:9.
doi: 10.1186/1472-6904-11-9.

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin

Jorge A Diaz #  1 , Edelberto Silva #  1 , Maria J Arias  2 , María Garzón  1
Affiliations

Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin

Jorge A Diaz et al. BMC Clin Pharmacol. .

Abstract

Background: One of the most critical problems about antimicrobial therapy is the increasing resistance to antibiotics. Previous studies have shown that there is a direct relation between erroneous prescription, dosage, route, duration of the therapy and the antibiotics resistance. Other important point is the uncertainty about the quality of the prescribed medicines. Some physicians believe that generic drugs are not as effective as innovator ones, so it is very important to have evidence that shows that all commercialized drugs are suitable for therapeutic use.

Methods: Microbial assays were used to establish the potency, the Minimal Inhibitory Concentrations (MICs), the Minimal Bactericidal Concentration (MBCs), the critical concentrations, and the production of spontaneous mutants that are resistant to vancomycin.

Results: The microbial assay was validated in order to determine the Vancomycin potency of the tasted samples. All the products showed that have potency values between 90 - 115% (USP requirement). The products behave similarly because the MICs, The MBCs, the critical concentrations, the critical concentrations ratios between standard and samples, and the production of spontaneous mutants don't have significant differences.

Conclusions: All products analyzed by microbiological tests, show that both trademarks and generics do not have statistical variability and the answer of antimicrobial activity Show also that they are pharmaceutical equivalents.

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Figures

Figure 1
Figure 1
Bioassay of Vancomycin (USP standard) against Bacillus subtilis ATCC 6633.
Figure 2
Figure 2
Calibration curve of Vancomycin (USP standard) used to evaluate the linearity of the optimal concentration range.
Figure 3
Figure 3
MIC assays of vancomycin products against K. pneumoniae 63.
Figure 4
Figure 4
Zones of inhibition produced by Vancomycin against (A) E. gallinarum, (B) A. baumanii 54, (C) K. pneumoniae 1, (D) P. aeruginosa 43, (E) P. aeruginosa 74 and (F) S. aureus 291.
Figure 5
Figure 5
Determination of critical concentration of Vancomycin against P. aeruginosa 74.
Figure 6
Figure 6
Production of spontaneous vancomycin-resistant mutants of E. gallinarum.
See this image and copyright information in PMC

References

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