Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers
Considering the importance of fluoroquinolones in animal health and the fact that the enrofloxacin patent has expired, a bioequivalence study of seventeen preparations of enrofloxacin vs. the reference preparation (Baytril®) in broilers was carried out. Oral pharmacokinetics of seventeen co...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Japan Poultry Science Association
2006-02-01
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| Series: | The Journal of Poultry Science |
| Subjects: | |
| Online Access: | https://www.jstage.jst.go.jp/article/jpsa/43/1/43_1_23/_pdf/-char/en |
| _version_ | 1797816246133063680 |
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| author | Hector Sumano Lilia Gutierrez Luis Ocampo |
| author_facet | Hector Sumano Lilia Gutierrez Luis Ocampo |
| author_sort | Hector Sumano |
| collection | DOAJ |
| description | Considering the importance of fluoroquinolones in animal health and the fact that the enrofloxacin patent has expired, a bioequivalence study of seventeen preparations of enrofloxacin vs. the reference preparation (Baytril®) in broilers was carried out. Oral pharmacokinetics of seventeen commercial enrofloxacin preparations and Baytril as reference preparation were assessed in five trials in a total of 1760 broilers. Ten mg/kg of each preparation was administered to a total of 80 clinically healthy 3 weeks old broilers. After drug administration, blood was collected 8 times from ten birds within 24h. Using a microbiological agar diffusion analysis, serum concentration of enrofloxacin and metabolites were determined by correlating the composite antibacterial activity of enrofloxacin and metabolites with actual concentration. Bioequivalence limits were set between 80 to 125% reference values for maximum serum concentration (Csmax) and area under the curve (AUC). Results display mean Baytril® values of Csmax=1.662μg/ml±0.034 ; AUC=4.073±0.814μg/ml/hr. Only three preparations out of seventeen could be regarded as bioequivalent while the rest gave AUC and/or Csmax values smaller than the accepted lower limit of the mean values obtained for the reference enrofloxacin (P<0.05). The use of non-bioequivalent preparations of enrofloxacin will consequently undermine clinical outcomes and could play a significant role in accelerating the emergence of bacterial resistance in the poultry industry. |
| first_indexed | 2024-03-13T08:35:56Z |
| format | Article |
| id | doaj.art-4f9b7b8b7106455d96949f22c18f3339 |
| institution | Directory Open Access Journal |
| issn | 1346-7395 1349-0486 |
| language | English |
| last_indexed | 2024-03-13T08:35:56Z |
| publishDate | 2006-02-01 |
| publisher | Japan Poultry Science Association |
| record_format | Article |
| series | The Journal of Poultry Science |
| spelling | doaj.art-4f9b7b8b7106455d96949f22c18f33392023-05-31T00:17:56ZengJapan Poultry Science AssociationThe Journal of Poultry Science1346-73951349-04862006-02-01431232810.2141/jpsa.43.23jpsaBioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in BroilersHector Sumano0Lilia Gutierrez1Luis Ocampo2Department of Physiology and Pharmacology, School of Veterina Medicine, National Autonomous University of MexicoDepartment of Physiology and Pharmacology, School of Veterina Medicine, National Autonomous University of MexicoDepartment of Physiology and Pharmacology, School of Veterina Medicine, National Autonomous University of MexicoConsidering the importance of fluoroquinolones in animal health and the fact that the enrofloxacin patent has expired, a bioequivalence study of seventeen preparations of enrofloxacin vs. the reference preparation (Baytril®) in broilers was carried out. Oral pharmacokinetics of seventeen commercial enrofloxacin preparations and Baytril as reference preparation were assessed in five trials in a total of 1760 broilers. Ten mg/kg of each preparation was administered to a total of 80 clinically healthy 3 weeks old broilers. After drug administration, blood was collected 8 times from ten birds within 24h. Using a microbiological agar diffusion analysis, serum concentration of enrofloxacin and metabolites were determined by correlating the composite antibacterial activity of enrofloxacin and metabolites with actual concentration. Bioequivalence limits were set between 80 to 125% reference values for maximum serum concentration (Csmax) and area under the curve (AUC). Results display mean Baytril® values of Csmax=1.662μg/ml±0.034 ; AUC=4.073±0.814μg/ml/hr. Only three preparations out of seventeen could be regarded as bioequivalent while the rest gave AUC and/or Csmax values smaller than the accepted lower limit of the mean values obtained for the reference enrofloxacin (P<0.05). The use of non-bioequivalent preparations of enrofloxacin will consequently undermine clinical outcomes and could play a significant role in accelerating the emergence of bacterial resistance in the poultry industry.https://www.jstage.jst.go.jp/article/jpsa/43/1/43_1_23/_pdf/-char/enbioequivalencebroilersenrofloxacin |
| spellingShingle | Hector Sumano Lilia Gutierrez Luis Ocampo Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers The Journal of Poultry Science bioequivalence broilers enrofloxacin |
| title | Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers |
| title_full | Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers |
| title_fullStr | Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers |
| title_full_unstemmed | Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers |
| title_short | Bioequivalence Comparison of Seventeen Commercial Oral Enrofloxacins against the Original Pioneer Preparation in Broilers |
| title_sort | bioequivalence comparison of seventeen commercial oral enrofloxacins against the original pioneer preparation in broilers |
| topic | bioequivalence broilers enrofloxacin |
| url | https://www.jstage.jst.go.jp/article/jpsa/43/1/43_1_23/_pdf/-char/en |
| work_keys_str_mv | AT hectorsumano bioequivalencecomparisonofseventeencommercialoralenrofloxacinsagainsttheoriginalpioneerpreparationinbroilers AT liliagutierrez bioequivalencecomparisonofseventeencommercialoralenrofloxacinsagainsttheoriginalpioneerpreparationinbroilers AT luisocampo bioequivalencecomparisonofseventeencommercialoralenrofloxacinsagainsttheoriginalpioneerpreparationinbroilers |