Development of a physiologically based pharmacokinetic model for flunixin in cattle (Bos taurus)

Food Additives and Contaminants - Part A

Volumn 31, Issue 9, 2014, Pages 1506-1521

  Leavens, Teresa L ^a   Tell, Lisa A ^b   Kissell, Lindsey W ^a   Smith, Geoffrey W ^a   Smith, David J ^c   Wagner, Sarah A ^d   Shelver, Weilin L ^c   Wu, Huali ^a,e   Baynes, Ronald E ^a   Riviere, Jim E ^a,f  

^a NORTH CAROLINA STATE UNIVERSITY   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c USDA ARS Red River Valley Agricultural Research Center   (United States)

^d NORTH DAKOTA STATE UNIVERSITY   (United States)

^e HAMNER INSTITUTES FOR HEALTH SCIENCES   (United States)

^f KANSAS STATE UNIVERSITY   (United States)

Author keywords

cattle (Bos taurus); flunixin; PBPK models; route of administration; withdrawal intervals

Indexed keywords

ANIMALS; DAIRIES; HISTOLOGY; METABOLITES; PARAMETER ESTIMATION; PHARMACOKINETICS; PHYSIOLOGY; TISSUE; UNCERTAINTY ANALYSIS;

BOS TAURUS; FLUNIXIN; PHARMACOKINETIC STUDIES; PHYSIOLOGICAL DIFFERENCES; PHYSIOLOGICAL PARAMETERS; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS; TOLERANCE CONCENTRATION; WITHDRAWAL INTERVALS;

PHYSIOLOGICAL MODELS;

DRUG RESIDUE; FLUNIXIN; CLONIXIN; NONSTEROID ANTIINFLAMMATORY AGENT;

ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BLOOD FLOW; BOS TAURUS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG EXCRETION; DRUG HYDROLYSIS; DRUG LIVER LEVEL; DRUG MILK LEVEL; DRUG TOLERABILITY; DRUG TRANSPORT; ENTEROHEPATIC CIRCULATION; KIDNEY; LIVER; MILK PRODUCTION; NONHUMAN; PHARMACOKINETICS; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; SIMULATION; TISSUE DISTRIBUTION; URINARY EXCRETION; ANALOGS AND DERIVATIVES; ANIMAL; BIOLOGICAL MODEL; BLOOD; BOVINAE; CHEMISTRY; COMPUTER PROGRAM; METABOLISM; MILK; SENSITIVITY AND SPECIFICITY; UNCERTAINTY;

ANIMALIA; BOS; BOS TAURUS;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CATTLE; CLONIXIN; DRUG RESIDUES; LIVER; MILK; MODELS, BIOLOGICAL; SENSITIVITY AND SPECIFICITY; SOFTWARE; UNCERTAINTY;

EID: 84906788604     PISSN: 19440049     EISSN: 19440057     Source Type: Journal    
DOI: 10.1080/19440049.2014.938363     Document Type: Article

References (68)

1. Anderson KL, Neff-Davis CA, Davis LE, Bass VD. 1990. Pharmacokinetics of flunixin meglumine in lactating cattle after single and multiple intramuscular and intravenous administrations. Am J Vet Res. 51:1464-1467.
2. Ayadi M, Caja G, Such X, Knight CH. 2003. Use of ultrasonography to estimate cistern size and milk storage at different milking intervals in the udder of dairy cows. J Dairy Res. 70:1-7.
3. Barton HA, Chiu WA, Setzer RW, Andersen ME, Bailer AJ, Bois FY, Dewoskin RS, Hays S, Johanson G, Jones N, et al. 2007. Characterizing uncertainty and variability in physiologically based pharmacokinetic models: state of the science and needs for research and implementation. Toxicol Sci. 99:395-402.
4. Beatty DT, Barnes A, Taylor E, Pethick D, McCarthy M, Maloney SK. 2006. Physiological responses of bos taurus and bos indicus cattle to prolonged, continuous heat and humidity. J Anim Sci. 84:972-985.
5. Bischoff KB, Dedrick RL, Zaharko DS, Longstreth JA. 1971. Methotrexate pharmacokinetics. J Pharm Sci. 60:1128-1133.
6. Blakely D. 2005. Cull dairy cow body weight and composition. Fact sheet ISSN 1198-712X, Queen's Printer for Ontario, Ontario Ministry of Agriculture, Food, and Rural Affairs, last reviewed 6/09 [Internet]. [cited 2014 Jul 17]. Available from: http://www.omafra.gov.on.ca/english/livestock/beef/facts/05-075.htm
7. Boner PL, Liu DD, Feely WF, Robinson RA, Wu J. 2003. Determination of flunixin in edible bovine tissues using liquid chromatography coupled with tandem mass spectrometry. J Agric Food Chem. 51:7555-7559.
8. Brocklebank JR, Namdari R, Law FC. 1997. An oxytetracycline residue depletion study to assess the physiologically based pharmacokinetic (PBPK) model in farmed Atlantic salmon. Can Vet J. 38:645-646.
9. Brown RP, Delp MD, Lindstedt SL, Rhomberg LR, Beliles RP. 1997. Physiological parameter values for physiologically based pharmacokinetic models. Toxicol Ind Health. 13:407-484.
10. Buur J, Baynes R, Smith G, Riviere J. 2006. Use of probabilistic modeling within a physiologically based pharmacokinetic model to predict sulfamethazine residue withdrawal times in edible tissues in swine. Antimicrob Agents Chemother. 50:2344-2351.
11. Buur JL, Baynes RE, Riviere JE. 2008. Estimating meat withdrawal times in pigs exposed to melamine contaminated feed using a physiologically based pharmacokinetic model. Regul Toxicol Pharmacol. 51:324-331.
12. Buur JL, Baynes RE, Smith GW, Riviere JE. 2009. A physiologically based pharmacokinetic model linking plasma protein binding interactions with drug disposition. Res Vet Sci. 86:293-301.
13. Cameron BD, Done JN, Young WB. 1985. The pharmacokinetics of flunixin (Finadyne) in the plasma and milk of lactating cows: a comparison between formulations. Eur Assoc Vet Pharmacol Toxicol. 3rd Cong:88.
14. Carruthers VR, Davis SR, Copeman PJ. 1993. Effects of oxytocin, machine stripping and milking rate on production loss of cows milked once a day. J Dairy Res. 60:13-18.
15. Cera D. 2011. Drug residues in animal derived foods [Internet]. In Presentation at the 2011 Veterinary-Laboratory Response Network Conference; Mar 3-4; Greenbelt (MD): FDA. [cited 2014 Jul 17]. Available from: http://www.fda.gov/AnimalVeterinary/ScienceResearch/ucm248790.htm
16. Clement RP, Simmons RD, Christopher RJ, Charles SF, Casciano CN, McCullough CB, Lamendola JF, Cayen MN. 1992. ACS Symposium Series; Xenobiotics and food-producing animals: metabolism and residues. Chapter 4, Design and conduct of studies to meet residue chemistry requirements: residue depletion and metabolism of flunixin in cattle. Washington (DC): American Chemical Society; p. 37-48.
17. Cortright KA, Wetzlich SE, Craigmill AL. 2009. A PBPK model for midazolam in four avian species. J Vet Pharmacol Ther. 32:552-565.
18. Covington TR, Gentry PR, Van Landingham CB, Andersen ME, Kester JE, Clewell HJ. 2007. The use of Markov chain Monte Carlo uncertainty analysis to support a Public Health Goal for perchloroethylene. Regul Toxicol Pharmacol. 47:1-18.
19. Craigmill AL. 2003. A physiologically based pharmacokinetic model for oxytetracycline residues in sheep. J Vet Pharmacol Ther. 26:55-63.
20. Daeseleire E, Mortier L, De Ruyck H, Geerts N. 2003. Determination of flunixin and ketoprofen in milk by liquid chromatography-tandem mass spectrometry. Anal Chim Acta. 488:25-34.
21. Davis SR, Farr VC, Copeman PJ, Carruthers VR, Knight CH, Stelwagen K. 1998. Partitioning of milk accumulation between cisternal and alveolar compartments of the bovine udder: relationship to production loss during once daily milking. J Dairy Res. 65:1-8.
22. De Buck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, Gilissen RA. 2007. Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs. Drug Metab Dispos. 35:1766-1780.
23. Deyrup CL, Southern KJ, Cornett JA, Shultz CE, Cera DA. 2012. Examining the occurrence of residues of flunixin meglumine in cull dairy cows by use of the flunixin cull cow survey. J Am Vet Med Assoc. 241:249-253.
24. Doyle JT, Patterson JL, Warren JV, Detweiler DK. 1960. Observations on the circulation of domestic cattle. Circ Res. 8:4-15.
25. Fajt VR, Wagner SA, Norby B. 2011. Analgesic drug administration and attitudes about analgesia in cattle among bovine practitioners in the United States. J Am Vet Med Assoc. 238:755-767.
26. Hagenbuch B. 2010. Drug uptake systems in liver and kidney: a historic perspective. Clin Pharmacol Ther. 87:39-47.
27. Hansard SL, Butler WO, Comar CL, Hobbs CS. 1953. Blood volume of farm animals. J Anim Sci. 12:402-413.
28. Hardee GE, Smith JA, Harris SJ. 1985. Pharmacokinetics of flunixin meglumine in the cow. Res Vet Sci. 39:110-112.
29. Hekman P, Schefferlie GJ. 2011. Kinetic modelling and residue depletion of drugs in eggs. Br Poult Sci. 52:376-380.
30. Horii Y, Ikenaga M, Shimoda M, Kokue E. 2004. Pharmacokinetics of flunixin in the cat: enterohepatic circulation and active transport mechanism in the liver. J Vet Pharmacol Ther. 27:65-69.
31. Jaroszewski J, Jedziniak P, Markiewicz W, Grabowski T, Chrostowska M, Szprengier-Juszkiewicz T. 2008. Pharmacokinetics of flunixin in mature heifers following multiple intravenous administration. Pol J Vet Sci. 11:199-203.
32. Kissell LW, Baynes RE, Riviere JE, Smith GW. 2013. Occurrence of flunixin residues in bovine milk samples from the USA. Food Addit Contam: Part A. 30:1513-1516.
33. Kissell LW, Smith GW, Leavens TL, Baynes R, Wu H, Riviere JE. 2012. Plasma pharmacokinetics and milk residues of flunixin and 5-hydroxy flunixin following different routes of administration in dairy cattle. J Dairy Sci. 95:7151-7157.
34. Knight CH, Dewhurst RJ. 1994. Once daily milking of dairy cows: relationship between yield loss and cisternal milk storage. J Dairy Res. 61:441-449.
35. KuKanich B, Gehring R, Webb AI, Craigmill AL, Riviere JE. 2005. Effect of formulation and route of administration on tissue residues and withdrawal times. J Am Vet Med Assoc. 227:1574-1577.
36. Landoni MF, Cunningham FM. 1995. Determination of pharmacokinetics and pharmacodynamics of flunixin in calves by use of pharmacokinetic-pharmacodynamic modeling. Am J Vet Res. 56:786-794.
37. Leavens TL, Tell LA, Clothier KA, Griffith RW, Baynes RE, Riviere JE. 2012. Development of a physiologically based pharmacokinetic model to predict tulathromycin distribution in goats. J Vet Pharmacol Ther. 35:121-131.
38. Leo A, Hansch C, Elkins D. 1971. Partition coefficients and their uses. Chem Rev. 71:525-616.
39. Lescoat P, Sauvant D, Danfaer A. 1996. Quantitative aspects of blood and amino acid flows in cattle. Reprod Nutr Dev. 36:137-174.
40. Lichtenwalner DM, Cameron BD, Young C. 1986. The metabolism and pharmacokinetics of flunixin in cows and steers. In Proceedings of the 14th World Congress on Diseases of Cattle. Vol. 2. Kenilworth (NJ): Schering Corporation and Musselburgh: Inveresk Research International, Ltd.; p. 1179-1183.
41. MacLachlan DJ. 2009. Influence of physiological status on residues of lipophilic xenobiotics in livestock. Food Addit Contam: Part A. 26:692-712.
42. Martinez M, Modric S. 2010. Patient variation in veterinary medicine: part I. Influence of altered physiological states. J Vet Pharmacol Ther. 33:213-226.
43. Mercer HD, Geleta JN, Schultz EJ, Wright WW. 1970. Milk-out rates for antibiotics in intramammary infusion products used in treatment of bovine mastitis - relationship of somatic cell counts, milk production level, and drug vehicle. Am J Vet Res. 31:1549-1560.
44. Mirzaei HR, Pitchford WS, Verbyla AP. 2011. Modeling of crossbred cattle growth, comparison between cubic and piecewise random regression models. Genet Mol Res. 10:2230-2244.
45. Nouws JF. 1992. Pharmacokinetics in immature animals: a review. J Anim Sci. 70:3627-3634.
46. Odensvik K. 1995. Pharmacokinetics of flunixin and its effect on prostaglandin-F2-alpha metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharmacol Ther. 18:254-259.
47. Odensvik K, Johansson IM. 1995. High-performance liquid chromatography method for determination of flunixin in bovine plasma and pharmacokinetics after single and repeated doses of the drug. Am J Vet Res. 56:489-495.
48. Pollet R, Glatz C, Dyer D. 1985. The pharmacokinetics of chlortetracycline orally administered to turkeys: influence of citric acid and Pasteurella multocida infection. J Pharmacokinet Pharmacodyn. 13:243-264.
49. Rantala M, Kaartinen L, Valimaki E, Stryrman M, Hiekkaranta M, Niemi A, Saari L, Pyorala S. 2002. Efficacy and pharmacokinetics of enrofloxacin and flunixin meglumine for treatment of cows with experimentally induced Escherichia coli mastitis. J Vet Pharmacol Ther. 25:251-258.
50. Rodgers T, Rowland M. 2006. Physiologically based pharmacokinetic modelling 2: predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions. J Pharm Sci. 95:1238-1257.
51. Romero MH, Uribe-Velásquez LF, Sánchez JA, Miranda-de la Lama GC. 2013. Risk factors influencing bruising and high muscle pH in colombian cattle carcasses due to transport and pre-slaughter operations. Meat Sci. 95:256-263.
52. Schering-Plough Animal Health Corporation. 2010. Flunixin Meglumine Solution Material Safety Data Sheet #SP000351 [Internet]. [cited 2014 Jul 17]. Available from: http://msd-safetydatasheets.c.om/frame.asp
53. Schmitt W. 2008. General approach for the calculation of tissue to plasma partition coefficients. Toxicol In vitro. 22:457-467.
54. Shelver WL, Tell LA, Wagner S, Wetzlich SE, Baynes RE, Riviere JE, Smith DJ. 2013. Comparison of ELISA and LC-MS/MS for the measurement of flunixin plasma concentrations in beef cattle after intravenous and subcutaneous administration. J Agr Food Chem. 61:2679-2686.
55. Skotnicka E, Muszczyñski Z, Dudzinska W, Suska M. 2007. A review of the renal system and diurnal variations of renal activity in livestock. Irish Vet J. 60:161-168.
56. Smith GW, Gehring R, Riviere JE, Yeatts JL, Baynes RE. 2004. Elimination kinetics of ceftiofur hydrochloride after intramammary administration in lactating dairy cows. J Am Vet Med Assoc. 224:1827-1830.
57. Swett WW, Miller FW, Graves RR, Matthews CA. 1933. Variations recorded in the study of the conformation and anatomy of 318 dairy cows having records of production. Washington (DC): United States, Bureau of Dairy Industry, Division of Dairy Cattle and Cattle Breeding, Feeding, and Management. Mimeo. Pub. BDIM-589.
58. USDA. 2012. United States Department of Agriculture-Food Safety Inspection Service Red Book. 2010 [Internet]. [cited 2014 Jul 17]. Available from: http://www.fsis.usda.gov/PDF/2010_Red_Book.pdf
59. USFDA. 1998. Freedom of Information Summary, Supplemental New Animal Drug Application for Banamine Injectable Solution (flunixin meglumine) NADA 101-479 [Internet]. [cited 2014 Jul 17]. Available from: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm064905.pdf
60. USFDA. 2004. Freedom of Information Summary, Supplemental New Animal Drug Application for Banamine Injectable Solution (flunixin meglumine) NADA 101-479 [Internet]. [cited 2014 Jul 17]. Available from: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm064910.pdf
61. USFDA. 2009. Freedom of Information Summary, Original New Animal Drug Application for Resflor Gold, Florfenicol and Flunixin Meglumine (in 2-pyrrolidone and triacetin) Injectable Solution, Beef and Non-Lactating Dairy Cattle, NADA 141-299 [Internet]. [cited 2014 Jul 17]. Available from: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM203309.pdf
62. USFDA. 2011. Freedom of Information Summary, Original New Animal Drug Application for Oxytetracycline and Flunixin Meglumine Injectable Solution, Beef and Non-Lactating Dairy Cattle, NADA 141-312 [Internet]. [cited 2014 Jul 17]. Available from: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM243040.pdf
63. USFDA. 2012. Beta Lactam And Other Test Methods For Use Under Appendix N And Section 6 Of The Grade "A" Pasteurized Milk Ordinance (PMO). Ma-a-85 Revision #14 [Internet]. [cited 2014 Jul 17]. Available from: www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/milk/ucm2007975.htm
64. Vetharaniam I, Davis SR, Soboleva TK, Shorten PR, Wake GC. 2003. Modeling the interaction of milking frequency and nutrition on mammary gland growth and lactation. J Dairy Sci. 86:1987-1996.
65. Whittem T, Whittem JH, Constable PD. 2012. Modelling the concentration-time relationship in milk from cattle administered an intramammary drug. J Vet Pharmacol Ther. 35:460-471.
66. Wu H, Baynes RE, Leavens TL, Tell LA, Riviere JE. 2013. Use of population pharmacokinetic modeling and monte carlo simulation to capture individual animal variability in the prediction of flunixin withdrawal times in cattle. J Vet Pharmacol Ther. 36:248-257.
67. Yang F, Liu HW, Li M, Ding HZ, Huang XH, Zeng ZL. 2012. Use of a Monte Carlo analysis within a physiologically based pharmacokinetic model to predict doxycycline residue withdrawal time in edible tissues in swine. Food Addit Contam: Part A. 29:73-84. doi:10.1080/19440049.2011.624126
68. Yuan LG, Luo XY, Zhu LX, Wang R, Liu YH. 2011. A physiologically based pharmacokinetic model for valnemulin in rats and extrapolation to pigs. J Vet Pharmacol Ther. 34:224-231.