Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration
Meloxicam is commonly prescribed for treating chickens in backyard or small commercial operations despite a paucity of scientific data establishing tissue withdrawal interval recommendations following extra-label drug use (ELDU). Historically, ELDU withdrawal intervals (WDIs) following meloxicam adm...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Veterinary Science |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fvets.2022.826367/full |
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| author | Emily D. Richards Emily D. Richards Rachel S. Dutch Nathaniel C. Burmas Jennifer L. Davis Zhoumeng Lin Maaike O. Clapham Maaike O. Clapham Scott E. Wetzlich Scott E. Wetzlich Lisa A. Tell Lisa A. Tell |
| author_facet | Emily D. Richards Emily D. Richards Rachel S. Dutch Nathaniel C. Burmas Jennifer L. Davis Zhoumeng Lin Maaike O. Clapham Maaike O. Clapham Scott E. Wetzlich Scott E. Wetzlich Lisa A. Tell Lisa A. Tell |
| author_sort | Emily D. Richards |
| collection | DOAJ |
| description | Meloxicam is commonly prescribed for treating chickens in backyard or small commercial operations despite a paucity of scientific data establishing tissue withdrawal interval recommendations following extra-label drug use (ELDU). Historically, ELDU withdrawal intervals (WDIs) following meloxicam administration to chickens have been based on the time when meloxicam concentrations fall below detectable concentrations in plasma and egg samples. To date, no studies have addressed tissue residues. ELDU WDIs are commonly calculated using terminal elimination half-lives derived from pharmacokinetic studies. This study estimated pharmacokinetic parameters for laying hens following meloxicam administration and compared ELDU WDIs calculated using tissue terminal elimination half-lives vs. those calculated using FDA tolerance and EMA's maximum regulatory limit statistical methods, respectively. In addition, ELDU WDIs were calculated using plasma meloxicam concentrations from live birds to determine if plasma data could be used as a proxy for estimating tissue WDIs. Healthy domestic hens were administered meloxicam at 1 mg/kg intravenous (IV) once, 1 mg/kg orally (PO) once daily for eight doses or 1 mg/kg PO twice daily for 20 doses. Analytical method validation was performed and meloxicam concentrations were quantified using high-performance liquid chromatography. In general, the terminal elimination technique resulted in the longest ELDU WDIs, followed by the FDA tolerance and then EMA's maximum residue limit methods. The longest ELDU WDIs were 72, 96, and 384 (or 120 excluding fat) h for the IV, PO once daily for eight doses, and PO twice daily for 20 doses, respectively. Plasma data are a possible dataset for estimating a baseline for tissue ELDU WDI estimations when tissue data are not available for chickens treated with meloxicam. Finally, pharmacokinetic parameters were similar in laying hens to those published for other avian species. |
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| id | doaj.art-9eef889cbc5e447a9a35afc3485dcf5e |
| institution | Directory Open Access Journal |
| issn | 2297-1769 |
| language | English |
| last_indexed | 2024-12-12T02:24:10Z |
| publishDate | 2022-03-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Veterinary Science |
| spelling | doaj.art-9eef889cbc5e447a9a35afc3485dcf5e2022-12-22T00:41:37ZengFrontiers Media S.A.Frontiers in Veterinary Science2297-17692022-03-01910.3389/fvets.2022.826367826367Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam AdministrationEmily D. Richards0Emily D. Richards1Rachel S. Dutch2Nathaniel C. Burmas3Jennifer L. Davis4Zhoumeng Lin5Maaike O. Clapham6Maaike O. Clapham7Scott E. Wetzlich8Scott E. Wetzlich9Lisa A. Tell10Lisa A. Tell11Food Animal Residue Avoidance and Depletion Program, Davis, CA, United StatesDepartment of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United StatesGenentech, Dixon, CA, United StatesDepartment of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United StatesDepartment of Biomedical Sciences and Pathobiology, Virginia-Maryland College of Veterinary Medicine, Blacksburg, VA, United StatesDepartment of Environmental and Global Health, College of Public Health and Health Professions, University of Florida, Gainesville, FL, United StatesFood Animal Residue Avoidance and Depletion Program, Davis, CA, United StatesDepartment of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United StatesFood Animal Residue Avoidance and Depletion Program, Davis, CA, United StatesDepartment of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United StatesFood Animal Residue Avoidance and Depletion Program, Davis, CA, United StatesDepartment of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, Davis, CA, United StatesMeloxicam is commonly prescribed for treating chickens in backyard or small commercial operations despite a paucity of scientific data establishing tissue withdrawal interval recommendations following extra-label drug use (ELDU). Historically, ELDU withdrawal intervals (WDIs) following meloxicam administration to chickens have been based on the time when meloxicam concentrations fall below detectable concentrations in plasma and egg samples. To date, no studies have addressed tissue residues. ELDU WDIs are commonly calculated using terminal elimination half-lives derived from pharmacokinetic studies. This study estimated pharmacokinetic parameters for laying hens following meloxicam administration and compared ELDU WDIs calculated using tissue terminal elimination half-lives vs. those calculated using FDA tolerance and EMA's maximum regulatory limit statistical methods, respectively. In addition, ELDU WDIs were calculated using plasma meloxicam concentrations from live birds to determine if plasma data could be used as a proxy for estimating tissue WDIs. Healthy domestic hens were administered meloxicam at 1 mg/kg intravenous (IV) once, 1 mg/kg orally (PO) once daily for eight doses or 1 mg/kg PO twice daily for 20 doses. Analytical method validation was performed and meloxicam concentrations were quantified using high-performance liquid chromatography. In general, the terminal elimination technique resulted in the longest ELDU WDIs, followed by the FDA tolerance and then EMA's maximum residue limit methods. The longest ELDU WDIs were 72, 96, and 384 (or 120 excluding fat) h for the IV, PO once daily for eight doses, and PO twice daily for 20 doses, respectively. Plasma data are a possible dataset for estimating a baseline for tissue ELDU WDI estimations when tissue data are not available for chickens treated with meloxicam. Finally, pharmacokinetic parameters were similar in laying hens to those published for other avian species.https://www.frontiersin.org/articles/10.3389/fvets.2022.826367/fullpharmacokineticsmeloxicamdomestic chickendrug residuemeat withdrawal |
| spellingShingle | Emily D. Richards Emily D. Richards Rachel S. Dutch Nathaniel C. Burmas Jennifer L. Davis Zhoumeng Lin Maaike O. Clapham Maaike O. Clapham Scott E. Wetzlich Scott E. Wetzlich Lisa A. Tell Lisa A. Tell Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration Frontiers in Veterinary Science pharmacokinetics meloxicam domestic chicken drug residue meat withdrawal |
| title | Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration |
| title_full | Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration |
| title_fullStr | Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration |
| title_full_unstemmed | Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration |
| title_short | Pharmacokinetic Parameters and Estimating Extra-Label Tissue Withdrawal Intervals Using Three Approaches and Various Matrices for Domestic Laying Chickens Following Meloxicam Administration |
| title_sort | pharmacokinetic parameters and estimating extra label tissue withdrawal intervals using three approaches and various matrices for domestic laying chickens following meloxicam administration |
| topic | pharmacokinetics meloxicam domestic chicken drug residue meat withdrawal |
| url | https://www.frontiersin.org/articles/10.3389/fvets.2022.826367/full |
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