Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin
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1 Universidad Nacional de Colombia, Facultad de Ciencias, Departamento de Farmacia, Laboratorio de Asesorías e Investigaciones en Microbiología, 472. Ciudad Universitaria. Carrera 30 Calle 45. A.A.14490. Bogotá D. C. Colombia
2 Vitalis Pharmaceutical, Proyectos Especiales, Carrera 7 No 156-80. Oficina No 1104. Bogotá D. C. Colombia
BMC Clinical Pharmacology 2011, 11:9 doi:10.1186/1472-6904-11-9Published: 21 July 2011
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.
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.
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.
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.