Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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.

PubMed Disclaimer

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

Similar articles

See all similar articles

References

    1. CENTERS FOR DISEASE CONTROL AND PREVENTION, FOOD AND DRUG ADMINISTRATION, NATIONAL INSTITUTES OF HEALTH. A Public Health Action Plan to Combat Antimicrobial Resistance; http://www.cdc.gov/drugresistance/pdf/2010/Interagency-Action-Plan-PreCl...
    1. Biological test and assays. Pharmacopoeia Convention Inc Bronx New York USA; 1883. THE UNITED STATES PHARMACOPOEIA. XXVII; p. 358.
    1. INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. Validation of Analytical Procedures: Text and Methodology. Q2 (R1). Current Step 4 version. Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)
    1. Jones RN, Fritsche TR, Moet GJ. In vitro potency evaluations of various piperacillin/tazobactam generic products compared with the contemporary branded (Zosyn®, Wyeth) formulation. Diagnostic Microbiology and Infectious Disease. 2008;61:76–79. doi: 10.1016/j.diagmicrobio.2007.12.010. - DOI - PubMed
    1. Moeta Gary J, Wattersa Amy A, Sadera Helio S, Jonesx Ronald N. Expanded studies of piperacillin/Tazobactam formulations: variations among branded product lots and assessment of 46 generics lots. Diagnostic Microbiology and Infectious Disease. 2009;65:319–322. doi: 10.1016/j.diagmicrobio.2009.06.012. - DOI - PubMed

Publication types

MeSH terms