Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines

Autores
Mestorino, Olga Nora; Marchetti, María Laura; Lucas, Mariana Florencia; Modamio, Pilar; Zeinsteger, Pedro Adolfo; López Lastra, Claudia Cristina; Segarra, Ignacio; Mariño, Eduardo L.
Año de publicación
2016
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
Facultad de Ciencias Veterinarias
Materia
Ciencias Veterinarias
AUC
Bioequivalence
Bovines
Cmax
Oxytetracycline
Pharmacokinetics
Tmax
Nivel de accesibilidad
acceso abierto
Condiciones de uso
http://creativecommons.org/licenses/by/4.0/
Repositorio
SEDICI (UNLP)
Institución
Universidad Nacional de La Plata
OAI Identificador
oai:sedici.unlp.edu.ar:10915/85998

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network_name_str SEDICI (UNLP)
spelling Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovinesMestorino, Olga NoraMarchetti, María LauraLucas, Mariana FlorenciaModamio, PilarZeinsteger, Pedro AdolfoLópez Lastra, Claudia CristinaSegarra, IgnacioMariño, Eduardo L.Ciencias VeterinariasAUCBioequivalenceBovinesCmaxOxytetracyclinePharmacokineticsTmaxThe 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, C<sub>max</sub>, and the area under the concentration-versus-time curve extrapolated to infinity, AUC<sub>0-∞</sub>) of both products. In the case of the time to maximum concentration (T<sub>max</sub>), non-parametric tests based on Wilcoxon's signed rank test were preferred. The comparison of the mean AUC<sub>0-∞</sub> 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 T<sub>max</sub> (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean C<sub>max</sub> 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 AUC<sub>0-∞</sub> and T<sub>max</sub> values for the reference and test product are within the interval 80-125%, but the 90% confidence intervals for the ratio of C<sub>max</sub> falls outside the proposed interval. It was concluded that C<sub>max</sub> 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.Facultad de Ciencias Veterinarias2016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArticulohttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfhttp://sedici.unlp.edu.ar/handle/10915/85998enginfo:eu-repo/semantics/altIdentifier/issn/2297-1769info:eu-repo/semantics/altIdentifier/doi/10.3389/fvets.2016.00050info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/4.0/Creative Commons Attribution 4.0 International (CC BY 4.0)reponame:SEDICI (UNLP)instname:Universidad Nacional de La Platainstacron:UNLP2025-10-22T16:57:37Zoai:sedici.unlp.edu.ar:10915/85998Institucionalhttp://sedici.unlp.edu.ar/Universidad públicaNo correspondehttp://sedici.unlp.edu.ar/oai/snrdalira@sedici.unlp.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:13292025-10-22 16:57:37.33SEDICI (UNLP) - Universidad Nacional de La Platafalse
dc.title.none.fl_str_mv Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
title Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
spellingShingle Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
Mestorino, Olga Nora
Ciencias Veterinarias
AUC
Bioequivalence
Bovines
Cmax
Oxytetracycline
Pharmacokinetics
Tmax
title_short Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
title_full Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
title_fullStr Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
title_full_unstemmed Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
title_sort Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
dc.creator.none.fl_str_mv Mestorino, Olga Nora
Marchetti, María Laura
Lucas, Mariana Florencia
Modamio, Pilar
Zeinsteger, Pedro Adolfo
López Lastra, Claudia Cristina
Segarra, Ignacio
Mariño, Eduardo L.
author Mestorino, Olga Nora
author_facet Mestorino, Olga Nora
Marchetti, María Laura
Lucas, Mariana Florencia
Modamio, Pilar
Zeinsteger, Pedro Adolfo
López Lastra, Claudia Cristina
Segarra, Ignacio
Mariño, Eduardo L.
author_role author
author2 Marchetti, María Laura
Lucas, Mariana Florencia
Modamio, Pilar
Zeinsteger, Pedro Adolfo
López Lastra, Claudia Cristina
Segarra, Ignacio
Mariño, Eduardo L.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Ciencias Veterinarias
AUC
Bioequivalence
Bovines
Cmax
Oxytetracycline
Pharmacokinetics
Tmax
topic Ciencias Veterinarias
AUC
Bioequivalence
Bovines
Cmax
Oxytetracycline
Pharmacokinetics
Tmax
dc.description.none.fl_txt_mv 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, C<sub>max</sub>, and the area under the concentration-versus-time curve extrapolated to infinity, AUC<sub>0-∞</sub>) of both products. In the case of the time to maximum concentration (T<sub>max</sub>), non-parametric tests based on Wilcoxon's signed rank test were preferred. The comparison of the mean AUC<sub>0-∞</sub> 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 T<sub>max</sub> (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean C<sub>max</sub> 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 AUC<sub>0-∞</sub> and T<sub>max</sub> values for the reference and test product are within the interval 80-125%, but the 90% confidence intervals for the ratio of C<sub>max</sub> falls outside the proposed interval. It was concluded that C<sub>max</sub> 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.
Facultad de Ciencias Veterinarias
description 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, C<sub>max</sub>, and the area under the concentration-versus-time curve extrapolated to infinity, AUC<sub>0-∞</sub>) of both products. In the case of the time to maximum concentration (T<sub>max</sub>), non-parametric tests based on Wilcoxon's signed rank test were preferred. The comparison of the mean AUC<sub>0-∞</sub> 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 T<sub>max</sub> (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean C<sub>max</sub> 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 AUC<sub>0-∞</sub> and T<sub>max</sub> values for the reference and test product are within the interval 80-125%, but the 90% confidence intervals for the ratio of C<sub>max</sub> falls outside the proposed interval. It was concluded that C<sub>max</sub> 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.
publishDate 2016
dc.date.none.fl_str_mv 2016
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info:eu-repo/semantics/publishedVersion
Articulo
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status_str publishedVersion
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dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/issn/2297-1769
info:eu-repo/semantics/altIdentifier/doi/10.3389/fvets.2016.00050
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http://creativecommons.org/licenses/by/4.0/
Creative Commons Attribution 4.0 International (CC BY 4.0)
eu_rights_str_mv openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
Creative Commons Attribution 4.0 International (CC BY 4.0)
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dc.source.none.fl_str_mv reponame:SEDICI (UNLP)
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