Development and application of a multiroute physiologically based pharmacokinetic model for oxytetracycline in dogs and humans

Journal of Pharmaceutical Sciences

Volumn 104, Issue 1, 2015, Pages 233-243

  Lin, Zhoumeng ^a   Li, Mengjie ^a   Gehring, Ronette ^a   Riviere, Jim E ^a  

^a KANSAS STATE UNIVERSITY   (United States)

Author keywords

Computational adme; Disposition; Dogs; Food animal residue avoidance databank (FARAD); In silico modeling; Mathematical model; Oxytetracycline; Pharmacokinetics; Physiologically based pharmacokinetic (PBPK) modeling; Tetracycline antibiotics

Indexed keywords

OXYTETRACYCLINE; TETRACYCLINE; ANTIINFECTIVE AGENT;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; DISSOLUTION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG TISSUE LEVEL; FEMALE; HUMAN; MALE; MONGREL DOG; NONHUMAN; QUANTITATIVE ANALYSIS; SINGLE DRUG DOSE; ANIMAL; BIOLOGICAL MODEL; BIOLOGY; BLOOD; CLINICAL PHARMACOLOGY; COMPUTER SIMULATION; DOG; DOSE RESPONSE; DRUG DATABASE; INBRED STRAIN; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY; METABOLISM; ORAL DRUG ADMINISTRATION; PHYSIOLOGY; PROCEDURES; REPRODUCIBILITY; SPECIES DIFFERENCE; TISSUE DISTRIBUTION; URINARY EXCRETION; VALIDATION STUDY; VETERINARY MEDICINE;

ADMINISTRATION, ORAL; ANIMALS; ANIMALS, INBRED STRAINS; ANTI-BACTERIAL AGENTS; COMPUTATIONAL BIOLOGY; COMPUTER SIMULATION; DATABASES, PHARMACEUTICAL; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; INJECTIONS, INTRAMUSCULAR; INJECTIONS, INTRAVENOUS; KIDNEY; MODELS, BIOLOGICAL; OXYTETRACYCLINE; PHARMACOLOGY, CLINICAL; PHYSIOLOGY, COMPARATIVE; RENAL ELIMINATION; REPRODUCIBILITY OF RESULTS; SPECIES SPECIFICITY; TISSUE DISTRIBUTION; VETERINARY MEDICINE;

EID: 84919782699     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24244     Document Type: Article

References (61)

1. Lindsay R, Zhou H, Cosman F, Nieves J, Dempster D. 2013. Double and quadruple tetracycline labeling of bone: Impact of the label itself. J Bone Miner Res 28(1):222-223.
2. Papich MG, Riviere JE. 2009. Chapter 35: Tetracycline antibiotics. In Veterinary pharmacology & therapeutics; Riviere JE, Papich MG, Ed. Ames, Iowa: Wiley-Blackwell, pp 895-914.
3. Chopra I, Roberts M. 2001. Tetracycline antibiotics: Mode of action, applications, molecular biology, and epidemiology of bacterial resistance. Microbiol Mol Biol Rev 65(2):232-260.
4. Martin-Jimenez T, Craigmill AL, Riviere JE. 1997. Extralabel use of oxytetracycline. J Am Vet Med Assoc 211(1):42-44.
5. Yonar ME. 2012. The effect of lycopene on oxytetracyclineinduced oxidative stress and immunosuppression in rainbow trout (Oncorhynchus mykiss, W.). Fish Shellfish Immunol 32(6):994-1001.
6. Moalli MR, Dysko RC, Rush HG, Chrisp CE, Decoster JL, Sweet KA, Goldstein SA. 1996. Oxytetracycline-induced nephrotoxicosis in dogs after intravenous administration for experimental bone labeling. Lab Anim Sci 46(5):497-502.
7. Riond JL, Riviere JE. 1989. Effects of tetracyclines on the kidney in cattle and dogs. J Am Vet Med Assoc 195(7):995-997.
8. Stevenson S. 1980. Oxytetracycline nephrotoxicosis in two dogs. J Am Vet Med Assoc 176(6):530-531.
9. EPA. 1988. Guidance for the reregistration of pesticide products containing oxytetracycline, oxytetracycline hydrochlorid, oxytetracycline calcium complex as the active ingredient. Office of Pesticide Program, Environmental Protection Agency, Washington, D. C. pp 8-16.
10. Craigmill AL, Miller GR, Gehring R, Pierce AN, Riviere JE. 2004. Meta-analysis of pharmacokinetic data of veterinary drugs using the Food Animal Residue Avoidance Databank: Oxytetracycline and procaine penicillin G. J Vet Pharmacol Ther 27(5):343-353.
11. Baggot JD, Powers TE, Powers JD, Kowalski JJ, Kerr KM. 1978. Pharmacokinetics and dosage of oxytetracycline in dogs. Res Vet Sci 24(1):77-81.
12. Craigmill AL. 2003. A physiologically based pharmacokinetic model for oxytetracycline residues in sheep. J Vet Pharmacol Ther 26(1):55-63.
13. Clewell RA, Clewell HJ 3rd. 2008. Development and specification of physiologically based pharmacokinetic models for use in risk assessment. Regul Toxicol Pharmacol 50(1):129-143.
14. Reddy MB, Yang R S H, Clewell HJ 3rd, Andersen ME. 2005. Physiologically based pharmacokinetic modeling: Science and application. Hoboken, New Jersey: John Wiley & Sons, Inc., pp 1-400.
15. Yang B, Huang LL, Fang K, Wang YL, Peng DP, Liu ZL, Yuang ZH. 2014. A physiologically based pharmacokinetic model for the prediction of the depletion of methyl-3-quinoxaline-2-carboxylic acid, the marker residue of olaquindox, in the edible tissues of pigs. J Vet Pharmacol Ther 37(1):66-82.
16. Leavens TL, Tell LA, Kissell LW, Smith GW, Smith DJ, Wagner SA, Shelver WL, Wu H, Baynes RE, Riviere JE. 2014. Development of a physiologically based pharmacokinetic model for flunixin in cattle (Bos taurus). Food Addit Contam Part A, Chem Anal Control Expo Risk Assess 31(9):1506-1521.
17. 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(7):2344-2351.
18. Law FC. 1999. A physiologically based pharmacokinetic model for predicting the withdrawal period of oxytetracycline in cultured Chinook salmon (Onchorhynchus tshawytscha). In Xenobiotics in fish; Smith D, Gingerich WH, Beconi-Barker MG, Eds. New York: Kluwer Academic/Plenum Publishers, pp 105-121.
19. Achenbach TE. 2000. Physiological and classical pharmacokinetic models of oxytetracycline in cattle. British Columbia, Canada: Thesis for Master of Science, Department of Biological Sciences, Simon Fraser University. pp 1-129.
20. Immelman A, Dreyer G. 1981. Oxytetracycline plasma levels in dogs after intramuscular administration of two formulations. J S Afr Vet Assoc 52(3):191-193.
21. Immelman A. 1977. Blood levels of oxytetracycline in dogs after oral administration. J S Afr Vet Assoc 48(3):183-186.
22. von Wittenau M, Yeary R. 1963. The excretion and distribution in body fluids of tetracyclines after intravenous administration to dogs. J Pharmacol Exp Ther 140:258-266.
23. Kikuvi GM, Mitema ES, Buoro IB. 2001. The pharmacokinetics of a long-acting oxytetracycline formulation in healthy dogs and in dogs infected with Ehrlichia canis. Vet Res Commun 25(5):391-400.
24. Cooke RG, Knifton A, Murdoch DB, Yacoub IS. 1981. Bioavailability of oxytetracycline dihydrate tablets in dogs. J Vet Pharmacol Ther 4(1):11-13.
25. von Wittenau MS, Delahunt CS. 1966. The distribution of tetracyclines in tissues of dogs after repeated oral administration. J Pharmacol Exp Ther 152(1):164-169.
26. Kunin CM, Dornbush AC, Finland M. 1959. Distribution and excretion of four tetracycline analogues in normal young men. J Clin Invest 38:1950-1963.
27. Hart A, Barber HE, Calvey TN. 1975. Bioavailability and dissolution of different formulations of oxytetracycline preparations. Br J Clin Pharmacol 2(3):277-280.
28. Craigmill AL, Riviere JE, Webb AI. 2006. Tabulation of FARAD comparative and veterinary pharmacokinetic data. Ames, Iowa: Wiley-Blackwell Publishing, pp 1-935.
29. Sundlof SF, Craigmill AC, Riviere JE. 1986. Food Animal Residue Avoidance Databank (FARAD): A pharmacokinetic-based information resource. J Vet Pharmacol Ther 9(3):237-245.
30. Neuhoff S, Yeo KR, Barter Z, Jamei M, Turner DB, Rostami-Hodjegan A. 2013. Application of permeability-limited physiologicallybased pharmacokinetic models: Part II-Prediction of P-glycoprotein mediated drug-drug interactions with digoxin. J Pharm Sci 102(9):3161-3173.
31. Neuhoff S, Yeo KR, Barter Z, Jamei M, Turner DB, Rostami-Hodjegan A. 2013. Application of permeability-limited physiologicallybased pharmacokinetic models: Part I-digoxin pharmacokinetics incorporating P-glycoprotein-mediated efflux. J Pharm Sci 102(9):3145-3160.
32. Ball K, Bouzom F, Scherrmann JM, Walther B, Decleves X. 2012. Development of a physiologically based pharmacokinetic model for the rat central nervous system and determination of an in vitro-in vivo scaling methodology for the blood-brain barrier permeability of two transporter substrates, morphine and oxycodone. J Pharm Sci 101(11):4277-4292.
33. Ryan DM. 1993. Pharmacokinetics of antibiotics in natural and experimental superficial compartments in animals and humans. J Antimicrob Chemother 31(Suppl D):1-16.
34. Lin Z, Fisher JW, Ross MK, Filipov NM. 2011. A physiologically based pharmacokinetic model for atrazine and its main metabolites in the adult male C57BL/6 mouse. Toxicol Appl Pharmacol 251(1):16-31.
35. 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(3):224-231.
36. Lin Z, Fisher JW, Wang R, Ross MK, Filipov NM. 2013. Estimation of placental and lactational transfer and tissue distribution of atrazine and its main metabolites in rodent dams, fetuses, and neonates with physiologically based pharmacokinetic modeling. Toxicol Appl Pharmacol 273(1):140-158.
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(2):121-131.
38. 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(2):293-301.
39. 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(3):324-331.
40. Buur JL, Baynes RE, Craigmill AL, Riviere JE. 2005. Development of a physiologic-based pharmacokinetic model for estimating sulfamethazine concentrations in swine and application to prediction of violative residues in edible tissues. Am J Vet Res 66(10):1686-1693.
41. Nouws JF, Vree TB, Termond E, Lohuis J, van Lith P, Binkhorst GJ, Breukink HJ. 1985. Pharmacokinetics and renal clearanceof oxytetracycline after intravenous and intramuscular administration to dairy cows. Vet Q 7(4):296-305.
42. Vinegar A. 2001. PBPK modeling of canine inhalation exposures to halogenated hydrocarbons. Toxicol Sci 60(1):20-27.
43. Brown RP, Delp MD, Lindstedt SL, Rhomberg LR, Beliles RP. 1997. Physiological parameter values for physiologically based pharmacokinetic models. Toxicol Ind Health 13(4):407-484.
44. Craigmill AL, Holland RE, Robinson D, Wetzlich S, Arndt T. 2000. Serum pharmacokinetics of oxytetracycline in sheep and calves and tissue residues in sheep following a single intramuscular injection of a long-acting preparation. J Vet Pharmacol Ther 23(6):345-352.
45. Crowell SR, Henderson WM, Kenneke JF, Fisher JW. 2011. Development and application of a physiologically based pharmacokinetic model for triadimefon and its metabolite triadimenol in rats and humans. Toxicol Lett 205(2):154-162.
46. Mirfazaelian A, Kim KB, Anand SS, Kim HJ, Tornero-Velez R, Bruckner JV, Fisher JW. 2006. Development of a physiologically based pharmacokinetic model for deltamethrin in the adult male Sprague-Dawley rat. Toxicol Sci 93(2):432-442.
47. WHO. 2010. Characterization and application of physiologically based pharmacokinetic models in risk assessment. Geneva, Switzerland: World Health Organization, pp 21-37.
48. Boscan P, Pypendop BH, Siao KT, Francey T, Dowers K, Cowgill L, Ilkiw JE. 2010. Fluid balance, glomerular filtration rate, and urine output in dogs anesthetized for an orthopedic surgical procedure. Am J Vet Res 71(5):501-507.
49. Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. 1996. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: A 5-year randomized prospective study. J Urol 155(3):839-843.
50. Martinez M, Amidon G, Clarke L, Jones WW, Mitra A, Riviere J. 2002. Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part II. Physiological considerations. Adv Drug Deliv Rev 54(6):825-850.
51. Martinez MN, Papich MG. 2009. Factors influencing the gastric residence of dosage forms in dogs. J Pharm Sci 98(3):844-860.
52. Agwuh KN, MacGowan A. 2006. Pharmacokinetics and pharmacodynamics of the tetracyclines including glycylcyclines. J Antimicrob Chemother 58(2):256-265.
53. Calbet JA, MacLean DA. 1997. Role of caloric content on gastric emptying in humans. J Physiol 498(Pt 2):553-559.
54. Schrickx J, Fink-GremmelsJ. 2007. P-glycoprotein-mediated transport of oxytetracycline in the Caco-2 cell model. J Vet Pharmacol Ther 30(1):25-31.
55. Thiebaut F, Tsuruo T, Hamada H, Gottesman MM, Pastan I, Willingham MC. 1987. Cellular localization of the multidrug-resistance gene product P-glycoprotein in normal human tissues. Proc Natl Acad Sci USA 84(21):7735-7738.
56. Remenar JF. 2014. Making the leap from daily oral dosing to long acting injectables: Lessons from the antipsychotics. Mol Pharm 11(6):1739-1749.
57. Martin SA, Campbell JL, Tremblay RT, Fisher JW. 2012. Development of a physiologically based pharmacokinetic model for inhalation of jet fuels in the rat. Inhal Toxicol 24(1):1-26.
58. Martinez M, Augsburger L, Johnston T, Jones WW. 2002. Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part I: Biopharmaceutics and formulation considerations. Adv Drug Deliv Rev 54(6):805-824.
59. Ehrlein HJ, Prove J. 1982. Effect of viscosity of test meals on gastric emptying in dogs. Q J Exp Physiol 67(3):419-425.
60. Smith GW, Gehring R, Craigmill AL, Webb AI, Riviere JE. 2005. Extralabel intramammary use of drugs in dairy cattle. J Am Vet Med Assoc 226(12):1994-1996.
61. Martin-Jimenez T, Riviere JE. 2002. Mixed-effects modeling of the interspecies pharmacokinetic scaling of oxytetracycline. J Pharm Sci 91(2):331-341.