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
.jpg)
- Institución
- Universidad Nacional de La Plata
- OAI Identificador
- oai:sedici.unlp.edu.ar:10915/85998
Ver los metadatos del registro completo
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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. |
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2016 |
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2016 |
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eng |
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eng |
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