Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines
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 administere...
| Autores principales: | , , , , , , , |
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| Formato: | Articulo |
| Lenguaje: | Inglés |
| Publicado: |
2016
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| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/85998 |
| Aporte de: |
| id |
I19-R120-10915-85998 |
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| record_format |
dspace |
| institution |
Universidad Nacional de La Plata |
| institution_str |
I-19 |
| repository_str |
R-120 |
| collection |
SEDICI (UNLP) |
| language |
Inglés |
| topic |
Ciencias Veterinarias AUC Bioequivalence Bovines Cmax Oxytetracycline Pharmacokinetics Tmax |
| spellingShingle |
Ciencias Veterinarias AUC Bioequivalence Bovines Cmax Oxytetracycline Pharmacokinetics Tmax Mestorino, Olga Nora Marchetti, María Laura Lucas, Mariana Florencia Modamio, Pilar Zeinsteger, Pedro Adolfo López Lastra, Claudia Cristina Segarra, Ignacio Mariño, Eduardo L. Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines |
| topic_facet |
Ciencias Veterinarias AUC Bioequivalence Bovines Cmax Oxytetracycline Pharmacokinetics Tmax |
| 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. |
| format |
Articulo Articulo |
| author |
Mestorino, Olga Nora Marchetti, María Laura Lucas, Mariana Florencia Modamio, Pilar Zeinsteger, Pedro Adolfo López Lastra, Claudia Cristina Segarra, Ignacio Mariño, Eduardo L. |
| 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_sort |
Mestorino, Olga Nora |
| title |
Bioequivalence study of two long-acting formulations of oxytetracycline following intramuscular administration in bovines |
| 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 |
| publishDate |
2016 |
| url |
http://sedici.unlp.edu.ar/handle/10915/85998 |
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