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

Silva, Edelberto; Díaz, Jorge A. Soler; Arias, María Trinidad García; Hernández, Angela P; Torre, Andrés de la

doi:10.1186/1472-6904-10-3

Cited by 22 publications

(18 citation statements)

References 4 publications

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“…These techniques can be used in performance studies like those for the determination of a Minimal Inhibitory Concentration (MIC), Minimal Lethal Concentration, Critical Concentration and production of Spontaneous Mutants [8,9]. …”

Section: Introductionmentioning

confidence: 99%

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

Díaz

Silva

Arias³

et al. 2011

BMC Clin Pharmacol

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BackgroundOne 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.MethodsMicrobial 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.ResultsThe 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.ConclusionsAll 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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Section: Introductionmentioning

confidence: 99%

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

Díaz

Silva

Arias³

et al. 2011

BMC Clin Pharmacol

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“…These impurities can cause the agonistic‐antagonistic action responsible for the in vivo failure of some generics (Vesga et al ., ). Other authors are challenging this view, saying that these generics do not fulfill the quality standard for any particular pharmaceutical product (e.g., purity of content) (Silva et al ., ). This debate underscores the importance of qualifying the active pharmaceutical ingredient, regardless of whether it is a synthetic molecule (e.g., concerns associated with stereochemistry or the presence of residual solvents) or natural products (e.g., defining the various constituent in a fermentation product).…”

Section: Antibiotic Generics Bioequivalence and Therapeutic Equivalmentioning

confidence: 97%

The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics

Toutain

Bousquet‐mélou

2013

Vet Pharm & Therapeutics

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In both human and veterinary medicine, it has been shown that flooding the market with different generics and/or 'me-too' branded drugs has increased overall antibiotic consumption correlating with the emergence and spread of bacterial resistance to antibiotics. Another possible undesirable consequence of the promotion of generics is the promotion of an economic incentive that encourages the use of old drug products with very poor oral bioavailability, marketed with historical dosage regimens and extensively excreted in the environment. What veterinary medicine rather needs is new innovative and 'ecofriendly' antibiotics to actually enforce a more prudent use of antibiotics. For a pharmaceutical company, generics are inexpensive to manufacture and on a short-term basis, the generic market is very appealing. However, on a long-term basis, this marketing orientation provides a disincentive to the development of new and innovative products that will be required to meet the therapeutic needs of the veterinary community while being consistent with public health concerns. Indeed, for veterinary medicine, the key issue surrounding antibiotics is public health. It is the opinion of the authors that veterinary antibiotics and/or veterinary drug formulations should be innovative in terms of selectivity (no or minimal impact on the commensal gut flora), biodegradable (with minimal environmental disruption), and more expensive, with a strictly regulated market rather than unselective, cheap, and freely available drugs.

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“…MBC is recognized as the standard quantitative index of the bactericidal potency of antimicrobial agents. MBC is defined as the lowest concentration of antimicrobial agent that prevents the growth of a microorganism after subculturing to an antibiotic free medium [39] . MBC values reflect the antibiotic concentration at which 99.9% eradication of bacterial isolates occurs.…”

Section: Parameters Used To Define Potency Of Antibioticsmentioning

confidence: 99%

Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance

Dafale

Semwal

Rajput

et al. 2016

Journal of Pharmaceutical Analysis

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Antibiotics are the chemotherapeutic agents that kill or inhibit the pathogenic microorganisms. Resistance of microorganism to antibiotics is a growing problem around the world due to indiscriminate and irrational use of antibiotics. In order to overcome the resistance problem and to safely use antibiotics, the correct measurement of potency and bioactivity of antibiotics is essential. Microbiological assay and high performance liquid chromatography (HPLC) method are used to quantify the potency of antibiotics. HPLC method is commonly used for the quantification of potency of antibiotics, but unable to determine the bioactivity; whereas microbiological assay estimates both potency and bioactivity of antibiotics. Additionally, bioassay is used to estimate the effective dose against antibiotic resistant microbes.Simultaneously, microbiological assay addresses the several parameters such as minimal inhibitory concentration (MIC), minimum bactericidal concentration (MBC), mutation prevention concentration (MPC) and critical concentration (Ccr) which are used to describe the potency in a more informative way. Microbiological assay is a simple, sensitive, precise and cost effective method which gives reproducible results similar to HPLC. However, the HPLC cannot be a complete substitute for microbiological assay and both methods have their own significance to obtain more realistic and precise results.

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

Cited by 22 publications

References 4 publications

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

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

The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics

Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance

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