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DC Field | Value | Language |
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dc.contributor.author | Mestorino, Nora | - |
dc.contributor.author | Marchetti, María Laura | - |
dc.contributor.author | Lucas, Mariana Florencia | - |
dc.contributor.author | Modamio Charles, Pilar | - |
dc.contributor.author | Zeinsteger, Pedro | - |
dc.contributor.author | Fernández Lastra, Cecilia | - |
dc.contributor.author | Segarra, Ignacio | - |
dc.contributor.author | Mariño Hernández, Eduardo L. | - |
dc.date.accessioned | 2019-09-23T08:25:31Z | - |
dc.date.available | 2019-09-23T08:25:31Z | - |
dc.date.issued | 2016-06-23 | - |
dc.identifier.issn | 2297-1769 | - |
dc.identifier.uri | http://hdl.handle.net/2445/140737 | - |
dc.description.abstract | The aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge Saude Animal). Both formulations were administered in a single intramuscular route at a dose of 20 mg OTC/kg of body weight in clinically healthy bovines. The study was carried out according to a one-period parallel design. Plasma samples were analyzed by high-pressure liquid chromatography. The limit of quantitation was 0.050 μg/mL with an accuracy of 101.67% with a coefficient of variation of 13.15%. Analysis of variance and 90% confidence interval tests were used to compare the bioavailability parameters (maximum plasma concentration, Cmax, and the area under the concentration-versus-time curve extrapolated to infinity, AUC0-∞) of both products. In the case of the time to maximum concentration (Tmax), non-parametric tests based on Wilcoxon's signed rank test were preferred. The comparison of the mean AUC0-∞ values did not reveal any significant differences (311.40 ± 93.05 μg h/mL and 287.71 ± 45.31 μg h/mL, respectively). The results were similar for the Tmax (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean Cmax some significant differences were found (8.73 ± 3.66 μg/mL and 10.43 ± 3.84 μg/mL, respectively). The 90% confidence intervals for the ratio of AUC0-∞ and Tmax values for the reference and test product are within the interval 80-125%, but the 90% confidence intervals for the ratio of Cmax falls outside the proposed interval. It was concluded that Cmax of test product are not within the 20% of those of the reference, thus suggesting that test OTC is not bioequivalent to the reference formulation. Keywords: oxytetracycline, pharmacokinetics, AUC, Cmax, Tmax, bioequivalence, bovines | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Frontiers Media | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3389/fvets.2016.00050 | - |
dc.relation.ispartof | Frontiers in Veterinary Sciences, 2016, vol. 3, num. 50 | - |
dc.relation.uri | https://doi.org/10.3389/fvets.2016.00050 | - |
dc.rights | cc-by (c) Mestorino, Nora et al., 2016 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es | - |
dc.source | Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica) | - |
dc.subject.classification | Farmacocinètica | - |
dc.subject.classification | Farmàcia clínica | - |
dc.subject.classification | Assaigs clínics de medicaments | - |
dc.subject.other | Pharmacokinetics | - |
dc.subject.other | Clinical pharmacy | - |
dc.subject.other | Drug testing | - |
dc.title | Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 662964 | - |
dc.date.updated | 2019-09-23T08:25:31Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 27446938 | - |
Appears in Collections: | Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica) |
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