Quantitative prediction of in vivo drug-Drug interactions from in vitro data based on physiological pharmacokinetics: Use of maximum unbound concentration of inhibitor at the inlet to the liver

Pharmaceutical Research

Volumn 17, Issue 3, 2000, Pages 336-343

  Kanamitsu, Shin Ichi ^a   Ito, Kiyomi ^b   Sugiyama, Yuichi ^a  

^a UNIVERSITY OF TOKYO   (Japan)

^b KITASATO UNIVERSITY   (Japan)

Author keywords

Drug interaction; Physiologically based pharmacokinetics; Prediction; Sulfaphenazole; Tolbutamide

Indexed keywords

CYTOCHROME; SULFAPHENAZOLE; TOLBUTAMIDE;

AREA UNDER THE CURVE; ARTICLE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG LIVER LEVEL; LIVER; MODEL; PREDICTION; PRIORITY JOURNAL; SIMULATION;

ANIMALS; ANTI-INFECTIVE AGENTS; ARYL HYDROCARBON HYDROXYLASES; CYTOCHROME P-450 ENZYME SYSTEM; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; LIVER; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS; STEROID 16-ALPHA-HYDROXYLASE; STEROID HYDROXYLASES; SULFAPHENAZOLE; TOLBUTAMIDE;

EID: 0033994866     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1007509324428     Document Type: Article

References (19)

1. 1. K. Ito, T. Iwatsubo, S. Kanamitsu, Y. Nakajima, and Y. Sugiyama. Quantitative prediction of in vivo drug clearance and drug interactions from in vitro data on metabolism, together with binding and transport. Annu. Rev. Pharmacol. Toxicol. 38:461-499 (1998).
2. 2. K. Ito, T. Iwatsubo, S. Kanamitsu, K. Ueda, H. Suzuki, and Y. Sugiyama. Prediction of pharmacokinetic alterations caused by drug-drug interactions: metabolic interaction in the liver. Pharmacol. Rev. 50:387-411 (1998).
3. 3. M. E. Veronese, J. O. Miners, D. Randles, D. Gregov, and D. J. Birkett. Validation of the tolbutamide metabolic ratio for population screening with use of sulfaphenazole to produce model phenotypic poor metabolizers. Clin. Pharmacol. Ther. 47:403-411 (1990).
4. 4. O. Sugita, Y. Sawada, Y. Sugiyama, T. Iga, and M. Hanano. Prediction of drug-drug interaction from in vitro plasma protein binding and metabolism: a study of tolbutamide-sulfonamide interaction in rats. Biochem. Pharmacol. 30: 3347-3354 (1981).
5. 5. D. J. Back and M. L'E. Orme. Genetic factors influencing the metabolism of tolbutamide. Pharmacol. Ther. 44:147-155 (1989).
6. 6. E. Nelson and I. O'Reilly. Kinetics of carboxytolbutamide excretion following tolbutamide and carboxytolbutamide administration. J. Pharmacol. Exp. Ther. 132:103-109 (1961).
7. 7. O. Sugita, Y. Sawada, Y. Sugiyama, T. Iga, and M. Hanano. Effect of sulfaphenazole on tolbutamide distribution in rabbits: analysis of interspecies differences in tissue distribution of tolbutamide. J. Pharm. Sci. 73:631-634 (1984).
8. 8. O. Sugita, Y. Sawada, Y. Sugiyama, T. Iga, and M. Hanano. Kinetic analysis of tolbutamide-sulfonamide interaction in rabbits based on clearance concept. Drug Metab. Dispos. 12:131-138 (1984).
9. 9. K. B. Bischoff, R. L. Dedrick, D. S. Zaharko, and J. A. Longstretth. Methotrexate pharmacokinetics. J. Pharm. Sci. 60:1128-1133 (1971).
10. 10. R. L. Dedrick. Animal scale-up. J. Pharmacokinet. Biopharm. 1:435-461 (1973).
11. 11. B. Montandon, R. J. Roberts, and L. J. Fischer. Computer simulation of sulfobromophthalein kinetics in the rat using flow-limited models with extrapolation to man. J. Pharmacokin. Biopharm. 3:277-290 (1975).
12. 12. J. O. Miners, K. J. Smith, R. A. Robson, M. E. McManus, M. E. Veronese, and D. J. Birkett. Tolbutamide hydroxylation by human liver microsomes. Biochem. Pharmacol. 37:1137-1144 (1988).
13. 13. G. F. Peart, J. Boutagy, and G. M. Shenfield. Lack of relationship between tolbutamide and debrisoquine oxidation phenotype. Eur. J. Clin. Pharmacol. 33:397-402 (1987).
14. 14. K. Tanioku and M. Nakahira. Long-acting sulfadrugs (in Japanese). Hifuka-no-Rinsho 2:717-724 (1960).
15. 15. T. B. Vree, E. W. J. B. Kolmer, and Y. A. Hekster. High pressure liquid chromatographic analysis and preliminary pharmacokinetics of sulfaphenazole and its N2-glucuronide and N4-acetyl metabolites in plasma and urine of man. Pharm. Weekblad Sci. Edition 12:243-246 (1990).
16. 16. R. J. Bertz and G. R. Granneman. Use of in vitro and in vivo data to estimate the likelihood of metabolic pharmacokinetic interactions. Clin. Pharmacokin. 32:210-258 (1997).
17. 17. L. L. von Moltke, D. J. Greenblatt, J. Schmider, C. E. Wright, J. S. Harmatz, and R. I. Shader. In vivo approaches to predicting drug interactions in vivo. Biochem. Pharmacol. 55:113-122 (1998).
18. 18. L. K. Christensen, J. M. Hansen, and M. Kristensen. Sulfaphenazole-induced hypoglycaemic attacks in tolbutamide-treated diabetics. Lancet 2:1298-1301 (1963).
19. 19. R. C. Thomas and G. J. Ikeda. The metabolic fate of tolbutamide in man and in the rat. J. Med. Chem. 9:507-510 (1966).