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

Author:

Diaz Jorge A,Silva Edelberto,Arias Maria J,Garzón María

Abstract

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.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

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-PreClearance-03-2011.pdf]

2. THE UNITED STATES PHARMACOPOEIA. XXVII. Biological test and assays. 1883, Pharmacopoeia Convention Inc Bronx New York USA, 358-

3. 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). 1994, October (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)

4. 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. 10.1016/j.diagmicrobio.2007.12.010.

5. Moeta Gary, Wattersa Amy, Sadera Helio, Jonesx Ronald: 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. 10.1016/j.diagmicrobio.2009.06.012.

Cited by 6 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3