Assessment of juvenile pigs to serve as human pediatric surrogates for preclinical formulation pharmacokinetic testing

AAPS Journal

Volumn 15, Issue 3, 2013, Pages 763-774

  Roth, Wyatt J ^a   Kissinger, Candice B ^a   McCain, Robyn R ^b   Cooper, Bruce R ^b   Marchant Forde, Jeremy N ^b,c   Vreeman, Rachel C ^d   Hannou, Sophia ^a   Knipp, Gregory T ^a,b  

^a PURDUE UNIVERSITY   (United States)

^b PURDUE UNIVERSITY   (United States)

^c AGRICULTURAL RESEARCH SERVICE   (United States)

^d INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

ADME; pediatric; pharmacokinetics; porcine; rifampin

Indexed keywords

RIFABUTIN; RIFAMPICIN;

AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CENTRIFUGATION; DRUG ABSORPTION; DRUG CAPSULE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SOLUBILITY; HUMAN; LIQUID CHROMATOGRAPHY; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PEDIATRICS; PHARMACODYNAMICS; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PREFORMULATION; SWINE; TABLET DISINTEGRATION; TABLET FORMULATION; TANDEM MASS SPECTROMETRY;

ADMINISTRATION, ORAL; AGE FACTORS; ANIMALS; BIOLOGICAL MARKERS; CHEMISTRY, PHARMACEUTICAL; DOGS; DRUG EVALUATION, PRECLINICAL; HAPLORHINI; HUMANS; MICE; MODELS, ANIMAL; RATS; RIFAMPIN; SPECIES SPECIFICITY; SUS SCROFA;

EID: 84879793564     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9482-6     Document Type: Article

References (72)

1. Shirkey H. Therapeutic orphans. J Pediatr. 1968;72:119-20.
2. Milne CP, Bruss JB. The economics of pediatric formulation development for off-patent drugs. Clin Ther. 2008;30:2133-45.
3. Hoppu K, Anabwani G, Garcia-Bournissen F, Gazarian M, Kearns GL, Nakamura H, et al. The status of paediatric medicines initiatives around the world - what has happened and what has not? Eur J Clin Pharmacol. 2012;68:1-10.
4. Rose K. Challenges in pediatric drug development: a pharmaceutical industry perspective. Paediatr Drugs. 2009;11:57-9.
5. Gazarian M. Delivering better medicines to children: need for better integration between the science, the policy, and the practice. Paediatr Drugs. 2009;11:41-4.
6. Schirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr. 2003;92:1486-9.
7. Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol. 2005;59:674-6.
8. Walters S. Report to WHO concerning international guidelines for paediatric medicines. Geneva: World Health Organization; 2010. http://www.who.int/childmedicines/paediatric-regulators/International- guidelines.pdf. Accessed 30 Aug 2012
9. Lam MS. Extemporaneous compounding of oral liquid dosage formulations and alternative drug delivery methods for anticancer drugs. Pharmacotherapy. 2011;31:164-92.
10. Blake MJ, Abdel-Rahman SM, Jacobs RF, Lowery NK, Sterling TR, Kearns GL. Pharmacokinetics of rifapentine in children. Pediatr Infect Dis J. 2006;25:405-9.
11. Notterman DA, Nardi M, Saslow JG. Effect of dose formulation on isoniazid absorption in two young children. Pediatrics. 1986;77:850-2.
12. Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clin Ther. 2008;30:2097-101.
13. De Cock RF, Piana C, Krekels EH, Danhof M, Allegaert K, Knibbe CA. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67:5-16.
14. Yu LX, Ellison CD, Hussain AS. Predicting human oral bioavailability using in silico models In: Krishna R, editor. Applications of pharmacokinetic principles in drug development. New York: Kluwer Academic/Plenum; 2004. p. 53-72.
15. Grass GM, Sinko PJ. Physiologically-based pharmacokinetic simulation modelling. Adv Drug Deliv Rev. 2002;54:433-51.
16. Swindle MM, Makin A, Herron AJ, Clubb FJ, Frazier KS. Swine as models in biomedical research and toxicology testing. Veterinary Pathology. 2012;49:344-56.
17. DeSesso JM, Williams AL. Contrasting the gastrointestinal tracts of mammals: factors that influence absorption. Ann Rep Med Chem. 2008;43:353-71.
18. Svendsen O. The minipig in toxicology. Exp Toxicol Pathol. 2006;57:335-9.
19. FDA. Guidance for industry nonclinical safety evaluation of pediatric drug products. Silver Spring: Food and Drug Administration; 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm079247.pdf. Accessed 30 Aug 2012.
20. EMA. Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications. London: European Medicines Agency; 2005. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/09/WC500003306.pdf. Accessed 30 Aug 2012.
21. Baldrick P. Juvenile animal testing in drug development - is it useful? Reg Tox Pharmacol. 2010;57:291-9.
22. Bode G, Clausing P, Gervais F, Loegsted J, Luft J, Nogues V, et al. The utility of the minipig as an animal model in regulatory toxicology. J Pharmacol Toxicol Methods. 2010;62:196-220.
23. Forster R, Ancian P, Fredholm M, Simianer H, Whitelaw B. The minipig as a platform for new technologies in toxicology. J Pharmacol Toxicol Methods. 2010;62:227-35.
24. Forster R, Bode G, Ellegaard L, van der Laan JW. The RETHINK project - minipigs as models for the toxicity testing of new medicines and chemicals: an impact assessment. J Pharmacol Toxicol Methods. 2010;62:158-9.
25. Forster R, Bode G, Ellegaard L, van der Laan JW. The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: conclusions and recommendations. J Pharmacol Toxicol Methods. 2010;62:236-42.
26. Kararli TT. Comparison of the gastrointestinal anatomy, physiology, and biochemistry of humans and commonly used laboratory-animals. Biopharm Drug Dispos. 1995;16:351-80.
27. van der Laan JW, Brightwell J, McAnulty P, Ratky J, Stark C, Project R. Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products. J Pharmacol Toxicol Methods. 2010;62:184-95.
28. Skaanild MT, Friis C. Characterization of the P450 system in Gottingen minipigs. Pharmacol Toxicol. 1997;80:28-33.
29. Skaanild MT, Friis C. Cytochrome P450 sex differences in minipigs and conventional pigs. Pharmacol Toxicol. 1999;85:174-80.
30. Skaanild MT, Friis C. Porcine CYP2A polymorphisms and activity. Basic Clin Pharmacol Toxicol. 2005;97:115-21.
31. Skaanild MT. Porcine cytochrome P450 and metabolism. Current Pharm Design. 2006;12:1421-7.
32. Fink-Gremmels J. Implications of hepatic cytochrome P450-related biotransformation processes in veterinary sciences. Eur J Pharmacol. 2008;585:502-9.
33. Goh LB, Spears KJ, Yao DG, Ayrton A, Morgan P, Wolf CR, et al. Endogenous drug transporters in in vitro and in vivo models for the prediction of drug disposition in man. Biochem Pharmacol. 2002;64:1569-78.
34. WHO. 3rd WHO model list of essential medicines for children. Geneva: World Health Organization; 2011. http://whqlibdoc.who.int/hq/2011/a95054-eng. pdf. Accessed 2 Jun 2012.
35. US Pharmacopeia. Rifampin capsules. Rockville: US Pharmacopeia; 2012. http://www.uspnf.com/uspnf/pub/index?usp=35&nf=30&s=0&officialOn= May 1, 2012. Accessed 23 Jan 2012.
36. Liu JF, Sun J, Zhang W, Gao K, He ZG. HPLC determination of rifampicin and related compounds in pharmaceuticals using monolithic column. J Pharm Biomed Analysis. 2008;46:405-9.
37. Marchant-Forde J, Matthews D, Poletto R, McCain R, Mann D, DeGraw R, et al. Plasma cortisol and noradrenalin concentrations in pigs: automated sampling of freely moving pigs housed in the PigTurn(R) versus manually sampled and restrained pigs Animal Welfare. 2012;21:197-205.
38. Naidong W, Shou WZ, Addison T, Maleki S, Jiang X. Liquid chromatography/tandem mass spectrometric bioanalysis using normal-phase columns with aqueous/organic mobile phases - a novel approach of eliminating evaporation and reconstitution steps in 96-well SPE. Rapid Commun Mass Spectrom. 2002;16:1965-75.
39. Hartkoorn RC, Khoo S, Back DJ, Tjia JF, Waitt CJ, Chaponda M, et al. A rapid and sensitive HPLC-MS method for the detection of plasma and cellular rifampicin. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;857:76-82.
40. US Pharmacopeia. Rifampin capsules. Rockville: US Pharmacopeia; 2012 http://www.uspnf.com/uspnf/display?cmd=jsp&page=chooser. Accessed 10 Sep 2012.
41. US Pharmacopeia. Disintegration. Rockville: US Pharmacopeia; 2012 http://www.uspnf.com/uspnf/display?cmd=jsp&page=chooser. Accessed 10 Sep 2012
42. Gal JY, Fovet Y, Adib-Yadzi M. About a synthetic saliva for in vitro studies. Talanta. 2001;53:1103-15.
43. Acocella G, Pagani V, Marchetti M, Baroni GC, Nicolis FB. Kinetic studies on rifampicin. I. Serum concentration analysis in subjects treated with different oral doses over a period of two weeks. Chemotherapy. 1971;16:356-70.
44. Acocella G. Pharmacokinetics and metabolism of rifampin in humans. Rev Infect Dis. 1983;5:S428-32.
45. Acocella G. Clinical pharmacokinetics of rifampicin. Clin Pharmacokinet. 1978;3:108-27.
46. Schaaf HS, Willemse M, Cilliers K, Labadarios D, Maritz JS, Hussey GD, et al. Rifampin pharmacokinetics in children, with and without human immunodeficiency virus infection, hospitalized for the management of severe forms of tuberculosis. BMC Med. 2009;7:19.
47. Hussels H, Kroening U, Magdorf K. Ethambutol and rifampicin serum levels in children: second report on the combined administration of ethambutol and rifampicin. Pneumonogie. 1973;149:31-8.
48. McCracken G, Ginsburg C, Zweighaft T, Clahsen J. Pharmacokinetics of rifampin in infants and children: relevance to prophylaxis against Haemophilus influenzae type B disease. Pediatrics. 1980;66:17-21.
49. Seth V, Beotra A, Bagga A, Seth S. Drug therapy in malnutrition. Indian J Pediatr. 1992;29:1341-6.
50. Seth V, Beotra A, Seth S, Semwal O, Kabra S, Jain Y. Serum concentrations of rifampicin and isoniazid in tuberculosis. Indian J Pediatr. 1993;30:1091-8.
51. Thee S, Detjen A, Wahn U, Magdorf K. Rifampicin serum levels in childhood tuberculosis. Int J Tuberc Lung Dis. 2009;13:1106-11.
52. Donald PR, Maritz JS, Diacon AH. The pharmacokinetics and pharmacodynamics of rifampicin in adults and children in relation to the dosage recommended for children. Tuberculosis. 2011;91:196-207.
53. Bruzzese T, Rimaroli C, Bonabello A, Mozzi G, Ajay S, Cooverj ND. Pharmacokinetics and tissue distribution of rifametane, a new 3-azinomethyl-rifamycin derivative, in several animal species. Arzneimittelforschung. 2000;50:60-71.
54. Pallanza R, Arioli V, Furesz S, Bolzoni G. Rifampicin: a new rifamycin. II. Laboratory studies on the antituberculous activity and preliminary clinical observations. Arzneimittelforschung. 1967;17:529-34.
55. Venturini AP. Pharmacokinetics of L/105, a new rifamycin, in rats and dogs, after oral administration. Chemotherapy. 1983;29:1-3.
56. Agrawal S, Panchagnula R. Implication of biopharmaceutics and pharmacokinetics of rifampicin in variable bioavailability from solid oral dosage forms. Biopharm Drug Dispos. 2005;26:321-34.
57. Finkel JM, Pittillo RF, Mellett LB. Fluorometric and microbiological assays for rifampicin and the determination of serum levels in the dog. Chemotherapy. 1971;16:380-8.
58. Stetter MD, Peloquin CA. Isoniazid and rifampin serum levels in a Colobus monkey (Colobus guereza caudatus) infected with Mycobacterium bovis. J Zoo Wildlife Med. 1995;26:152-4.
59. Ohtsuka T, Yoshikawa T, Kozakai K, Tsuneto Y, Uno Y, Utoh M, et al. Alprazolam as an in vivo probe for studying induction of CYP3A in cynomolgus monkeys. Drug Metab Dispos. 2010;38:1806-13.
60. Henwood SQ, de Villiers MM, Liebenberg W, Lotter AP. Solubility and dissolution properties of generic rifampicin raw materials. Drug Dev Ind Pharm. 2000;26:403-8.
61. Agrawal S, Ashokraj Y, Bharatam PV, Pillai O, Panchagnula R. Solid-state characterization of rifampicin samples and its biopharmaceutic relevance. Eur J Pharm Sci. 2004;22:127-44.
62. Katzung BG. Basic & clinical pharmacology. 9th ed. New York: Lange Medical Books/McGraw Hill; 2004.
63. CDC. Clinical growth charts. Atlanta: Centers for Disease Control and Prevention, National Center for Health Statistics; 2009. http://www.cdc.gov/ growthcharts/clinical-charts.htm. Accessed 31 Aug 2012.
64. Acocella G, Buniva G, Flauto U, Nicolis FB. Absorption and elimination of the antibiotic rifampicin in newborns and children. Proc. 6th Int Congress Chemother. 1969;2:755-60.
65. Koup JR, Williams-Warren J, Viswanathan CT, Weber A, Smith AL. Pharmacokinetics of rifampin in children. II. Oral bioavailability. Ther Drug Monit. 1986;8:17-22.
66. Schaaf HS, Parkin DP, Seifart HI, Werely CJ, Hesseling PB, van Helden PD, et al. Isoniazid pharmacokinetics in children treated for respiratory tuberculosis. Arch Dis Child. 2005;90:614-8.
67. Ramachandran G, Kumar AK, Swaminathan S. Pharmacokinetics of anti-tuberculosis drugs in children. Indian J Pediatr. 2011;78:435-42.
68. Tan TQ, Mason EO, Ou CN, Kaplan SL. Use of intravenous rifampin in neonates with persistent staphylococcal bacteremia. Antimicrob Agents Chemother. 1993;37:2401-6.
69. Chik Z, Basu RC, Pendek R, Lee TC, Mohamed Z. A bioequivalence comparison of two formulations of rifampicin (300- vs 150-mg capsules): An open-label, randomized, two-treatment, two-way crossover study in healthy volunteers. Clin Ther. 2010;32:1822-31.
70. Cohn HD. Clinical studies with a new rifamycin derivative. J Clin Pharmacol J New Drugs. 1969;9:118-25.
71. Lave T, Luttringer O, Poulin P, Parrott N. Interspecies scaling. In: Krishna R, editor. Applications of pharmacokinetic principles in drug development. New York: Kluwer Academic/Plenum; 2004. p. 133-69.
72. Webster J, Bollen P, Grimm H, Jennings M. Ethical implications of using the minipig in regulatory toxicology studies. J Pharmacol Toxicol Methods. 2010;62:160-6.