Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs
The aim of this study was to explore the bioequivalence of long-acting oxytetracycline in two formulations, a reference formulation (Terramycin 20% LA, Pfizer) and a test one (Kangtekang 20% LA, Huishen). Both formulations were administered intramuscularly at 20 mg/kg body weight at each of 24 healt...
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Frontiers Media S.A.
2017-05-01
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| Series: | Frontiers in Veterinary Science |
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| Online Access: | http://journal.frontiersin.org/article/10.3389/fvets.2017.00061/full |
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| author | Jiyue Cao Qigai He Zhixin Lei Qianying Liu Bing Yang Saeed Ahmed Jincheng Xiong Tingting Song Pin Chen |
| author_facet | Jiyue Cao Qigai He Zhixin Lei Qianying Liu Bing Yang Saeed Ahmed Jincheng Xiong Tingting Song Pin Chen |
| author_sort | Jiyue Cao |
| collection | DOAJ |
| description | The aim of this study was to explore the bioequivalence of long-acting oxytetracycline in two formulations, a reference formulation (Terramycin 20% LA, Pfizer) and a test one (Kangtekang 20% LA, Huishen). Both formulations were administered intramuscularly at 20 mg/kg body weight at each of 24 healthy animals during a two-period crossover parallel experimental design. The oxytetracycline (OTC) concentrations in plasma were measured by high-performance liquid chromatography, and the limit of quantification was 0.05 µg/ml with a recovery ratio of above 90%. Moreover, the descriptive pharmacokinetics parameters (Cmax, AUC0–144h, and AUC0–∞) were calculated and compared under analysis of variance, and 90% confidence interval (CI) were compared, except for Tmax analyzed by non-parametric tests based on Wilcoxons’s signed rank test. The comparison results of Cmax, AUC0–144h, AUC0–∞, and Tmax were 5.066 ± 0.486, 5.071 ± 0.877 µg/ml, 118.926 ± 13.259, 126.179 ± 17.390 µg h/ml, 123.087 ± 13.906, 130.732 ± 18.562 µg h/ml, 0.740 ± 0.278, 0.650 ± 0.258 h, respectively, and did not reveal any significant differences. In addition, 90% CIs of these ratios for reference and test product were within an interval of 80–125%, and the relative bioavailability of test one was (94.291 ± 15.287)%. Therefore, it has been concluded that test OTC was bioequivalent to the reference formulation in pigs. |
| first_indexed | 2024-12-12T07:13:34Z |
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| issn | 2297-1769 |
| language | English |
| last_indexed | 2024-12-12T07:13:34Z |
| publishDate | 2017-05-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Veterinary Science |
| spelling | doaj.art-60681ea189414d62ab43646ce98c2df22022-12-22T00:33:34ZengFrontiers Media S.A.Frontiers in Veterinary Science2297-17692017-05-01410.3389/fvets.2017.00061261617Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in PigsJiyue Cao0Qigai He1Zhixin Lei2Qianying Liu3Bing Yang4Saeed Ahmed5Jincheng Xiong6Tingting Song7Pin Chen8National Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaState Key Laboratory of Agriculture Microbiology, College of Veterinary Medicine, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaNational Reference Laboratory of Veterinary Drug Residues, MAO Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agriculture University, Wuhan, ChinaThe aim of this study was to explore the bioequivalence of long-acting oxytetracycline in two formulations, a reference formulation (Terramycin 20% LA, Pfizer) and a test one (Kangtekang 20% LA, Huishen). Both formulations were administered intramuscularly at 20 mg/kg body weight at each of 24 healthy animals during a two-period crossover parallel experimental design. The oxytetracycline (OTC) concentrations in plasma were measured by high-performance liquid chromatography, and the limit of quantification was 0.05 µg/ml with a recovery ratio of above 90%. Moreover, the descriptive pharmacokinetics parameters (Cmax, AUC0–144h, and AUC0–∞) were calculated and compared under analysis of variance, and 90% confidence interval (CI) were compared, except for Tmax analyzed by non-parametric tests based on Wilcoxons’s signed rank test. The comparison results of Cmax, AUC0–144h, AUC0–∞, and Tmax were 5.066 ± 0.486, 5.071 ± 0.877 µg/ml, 118.926 ± 13.259, 126.179 ± 17.390 µg h/ml, 123.087 ± 13.906, 130.732 ± 18.562 µg h/ml, 0.740 ± 0.278, 0.650 ± 0.258 h, respectively, and did not reveal any significant differences. In addition, 90% CIs of these ratios for reference and test product were within an interval of 80–125%, and the relative bioavailability of test one was (94.291 ± 15.287)%. Therefore, it has been concluded that test OTC was bioequivalent to the reference formulation in pigs.http://journal.frontiersin.org/article/10.3389/fvets.2017.00061/fulloxytetracyclinepharmacokineticsbioequivalenceformulationsconfidence interval |
| spellingShingle | Jiyue Cao Qigai He Zhixin Lei Qianying Liu Bing Yang Saeed Ahmed Jincheng Xiong Tingting Song Pin Chen Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs Frontiers in Veterinary Science oxytetracycline pharmacokinetics bioequivalence formulations confidence interval |
| title | Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs |
| title_full | Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs |
| title_fullStr | Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs |
| title_full_unstemmed | Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs |
| title_short | Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs |
| title_sort | evaluation of bioequivalence of two long acting 20 oxytetracycline formulations in pigs |
| topic | oxytetracycline pharmacokinetics bioequivalence formulations confidence interval |
| url | http://journal.frontiersin.org/article/10.3389/fvets.2017.00061/full |
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