Bioequivalence of two amoxicillin-potassium clavulanate oral preparations in dogs.
The aim of this trial was to carry out a bioequivalence (BE) study in dogs using a generic preparation of amoxicillin-potassium clavulanate vs a commercially available reference preparation, both claiming to achieve plasma concentrations that allow a 12 h dosing interval after oral administration. T...
| Publicado en: | Veterinaria México Vol. 42; no. 3; pp. 197 - 206 |
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| Autores principales: | , , , , |
| Formato: | Artículo |
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Facultad de Medicina Veterinaria y Zootecnia UNAM
jul-sep2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=lth&AN=66863909&site=ehost-live header: @attributes: shortDbName: lth uiTerm: 66863909 longDbName: MedicLatina uiTag: AN controlInfo: bkinfo: jinfo: jid: 03015092 7LD jtl: Veterinaria México issn: 03015092 maglogo: N pubinfo: dt: jul-sep2011 vid: 42 iid: 3 pid: 20869 pub: Facultad de Medicina Veterinaria y Zootecnia UNAM artinfo: ui: 66863909 ppf: 197 ppct: 9 formats: fmt: @attributes: type: P size: 6.5MB tig: atl: Bioequivalence of two amoxicillin-potassium clavulanate oral preparations in dogs. aug: au: Hayashida, Sayuri Gutiérrez, Lilia Villar, Jorge Luna del Osnaya, Fernando Sumano, Héctor affil: Departamento de Fisiologia y Farmacologia, Facultad de Medicina Veterinaria y Zootecnia, Universidad Nacional Autonoma de Mexico Departamento de Clinica y Cirugia en Pequefias Especies, Facultad de Medicina Veterinaria y Zootecnia, Universidad Nacional Aut6noma de México Departamento de Ciencias Pecuarias, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autonoma de Mexico su: Therapeutic equivalency in drugs Amoxicillin Potassium Drug development Drug administration Beta lactamases Pharmacokinetics Drug tablets Laboratory dogs sug: subj: Therapeutic equivalency in drugs Amoxicillin Potassium Drug development Drug administration Beta lactamases Pharmacokinetics Drug tablets Laboratory dogs keyword: Β-LACTAM AMOXICILLIN CLAVULANATEACID DOGS PHARMACOKINETICS TABLETS ab: The aim of this trial was to carry out a bioequivalence (BE) study in dogs using a generic preparation of amoxicillin-potassium clavulanate vs a commercially available reference preparation, both claiming to achieve plasma concentrations that allow a 12 h dosing interval after oral administration. The oral pharmacokinetic profiles of a single dose of each preparation were carried out in 12 adult mongrel dogs in a crossover model with a 10 day washout period at a dose of 12.5 mg/kg of trihydrate amoxicillin and potassium clavulanate as tablets. A composite determination of amoxicillin-potassium clavulanate concentration in each sample of plasma was carried out in triplicate, using a microbiological agar diffusion analysis. Pharmacokinetic analysis was carried out with a non-compartmental model. Statistical analysis of pharmacokinetic variables was carried out by ANOVA and Bonferroni t test, setting a P < 0.05. In accordance with international standards, it was found that the generic preparation failed to be bioequivalent, i.e: AUC0-∞ 9.08 ± 0.26 µg h/ml and Cmax 5.48 ± 0.19 µg/ml for the generic preparation vs AUC0-∞ 13.28 ± 0.30 µg h/ml and Cmax 2.9 ± 0.17 µg/ml for the reference one. A 0.25 µg/ml breakpoint can be set as minimum effective plasma concentration for amoxicillin; hence the generic preparation requires a dose interval of eight h. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: Y custom: Copyright of Veterinaria México is the property of Facultad de Medicina Veterinaria y Zootecnia UNAM and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. item: Veterinaria México holder: Facultad de Medicina Veterinaria y Zootecnia UNAM dt: @attributes: year: 2011 holdings: @attributes: islocal: N |
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