In vivo biliary clearance should be predicted by intrinsic biliary clearance in sandwich-cultured hepatocytes

Drug Metabolism and Disposition

Volumn 40, Issue 3, 2012, Pages 602-609

  Nakakariya, Masanori ^a   Ono, Midori ^a   Amano, Nobuyuki ^a   Moriwaki, Toshiya ^a   Maeda, Kazuya ^b   Sugiyama, Yuichi ^b  

^a TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^b UNIVERSITY OF TOKYO   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

CEFMETAZOLE; CEFOPERAZONE; CEFPIRAMIDE; OLMESARTAN; PRAVASTATIN; ROSUVASTATIN; TOPOTECAN; VALSARTAN;

ANIMAL CELL; ANIMAL CELL CULTURE; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BILIARY EXCRETION; CELL ISOLATION; CELL STRUCTURE; CONCENTRATION (PARAMETERS); CONTINUOUS INFUSION; CONTROLLED STUDY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG LIVER LEVEL; DRUG TRANSPORT; FLUORESCENCE MICROSCOPY; HEPATOBILIARY PARAMETERS; IN VIVO BILIARY CLEARANCE; LIVER CELL; MALE; NONHUMAN; PREDICTION; PRIORITY JOURNAL; RAT;

ANGIOTENSIN RECEPTOR ANTAGONISTS; ANIMALS; BETA-LACTAMS; BILIARY TRACT; BIOLOGICAL TRANSPORT; CELLS, CULTURED; HEPATOCYTES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; PHARMACEUTICAL PREPARATIONS; RATS; RATS, SPRAGUE-DAWLEY; TOPOTECAN;

EID: 84857396024     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.111.042101     Document Type: Article

References (35)

1. Abe K, Bridges AS, and Brouwer KL (2009) Use of sandwich-cultured human hepatocytes to predict biliary clearance of angiotensin II receptor blockers and HMG-CoA reductase inhibitors. Drug Metab Dispos 37:447-452.
2. Abe K, Bridges AS, Yue W, and Brouwer KL (2008) In vitro biliary clearance of angiotensin II receptor blockers and 3-hydroxy-3-methylglutaryl- coenzyme A reductase inhibitors in sandwich-cultured rat hepatocytes: comparison with in vivo biliary clearance. J Pharmacol Exp Ther 326:983-990.
3. Davies B and Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093-1095. (Pubitemid 23211439)
4. Dunn JC, Yarmush ML, Koebe HG, and Tompkins RG (1989) Hepatocyte function and extracellular matrix geometry: long-term culture in a sandwich configuration. FASEB J 3:174-177.
5. Foliot A, Glaise D, Erlinger S, and Guguen-Guillouzo C (1985) Long-term maintenance of taurocholate uptake by adult rat hepatocytes co-cultured with a liver epithelial cell line. Hepatology 5:215-219. (Pubitemid 15115997)
6. Fukuda H, Ohashi R, Tsuda-Tsukimoto M, and Tamai I (2008) Effect of plasma protein binding on in vitro-in vivo correlation of biliary excretion of drugs evaluated by sandwich-cultured rat hepatocytes. Drug Metab Dispos 36:1275-1282. (Pubitemid 351929311)
7. Hilgendorf C, Ahlin G, Seithel A, Artursson P, Ungell AL, and Karlsson J (2007) Expression of thirty-six drug transporter genes in human intestine, liver, kidney, and organotypic cell lines. Drug Metab Dispos 35:1333-1340. (Pubitemid 47121774)
8. Hirano M, Maeda K, Hayashi H, Kusuhara H, and Sugiyama Y (2005) Bile salt export pump (BSEP/ABCB11) can transport a nonbile acid substrate, pravastatin. J Pharmacol Exp Ther 314:876-882. (Pubitemid 41043874)
9. Hirano M, Maeda K, Shitara Y, and Sugiyama Y (2004) Contribution of OATP2 (OATP1B1) and OATP8 (OATP1B3) to the hepatic uptake of pitavastatin in humans. J Pharmacol Exp Ther 311:139-146. (Pubitemid 39287793)
10. Hoffmaster KA, Turncliff RZ, LeCluyse EL, Kim RB, Meier PJ, and Brouwer KL (2004) P-glycoprotein expression, localization, and function in sandwich-cultured primary rat and human hepatocytes: relevance to the hepatobiliary disposition of a model opioid peptide. Pharm Res 21:1294-1302. (Pubitemid 38954216)
11. Ito K, Iwatsubo T, Kanamitsu S, Nakajima Y, and Sugiyama Y (1998) 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. (Pubitemid 28231503)
12. Iwatsubo T, Hirota N, Ooie T, Suzuki H, Shimada N, Chiba K, Ishizaki T, Green CE, Tyson CA, and Sugiyama Y (1997) Prediction of in vivo drug metabolism in the human liver from in vitro metabolism data. Pharmacol Ther 73:147-171. (Pubitemid 27191615)
13. Kato Y, Suzuki H, and Sugiyama Y (2002) Toxicological implications of hepatobiliary transporters. Toxicology 181-182:287-290. (Pubitemid 36015715)
14. Kato Y, Takahara S, Kato S, Kubo Y, Sai Y, Tamai I, Yabuuchi H, and Tsuji A (2008) Involvement of multidrug resistance-associated protein 2 (Abcc2) in molecular weight-dependent biliary excretion of β-lactam antibiotics. Drug Metab Dispos 36:1088-1096. (Pubitemid 351717466)
15. Kitamura S, Maeda K, Wang Y, and Sugiyama Y (2008) Involvement of multiple transporters in the hepatobiliary transport of rosuvastatin. Drug Metab Dispos 36:2014-2023.
16. LeCluyse EL, Audus KL, and Hochman JH (1994) Formation of extensive canalicular networks by rat hepatocytes cultured in collagen-sandwich configuration. Am J Physiol 266:C1764-C1774. (Pubitemid 24220826)
17. Levine WG (1978) Biliary excretion of drugs and other xenobiotics. Annu Rev Pharmacol Toxicol 18:81-96.
18. Li N, Singh P, Mandrell KM, and Lai Y (2010) Improved extrapolation of hepatobiliary clearance from in vitro sandwich cultured rat hepatocytes through absolute quantification of hepatobiliary transporters. Mol Pharm 7:630-641.
19. Liu X, Chism JP, LeCluyse EL, Brouwer KR, and Brouwer KL (1999a) Correlation of biliary excretion in sandwich-cultured rat hepatocytes and in vivo in rats. Drug Metab Dispos 27:637-644. (Pubitemid 29252436)
20. Liu X, LeCluyse EL, Brouwer KR, Gan LS, Lemasters JJ, Stieger B, Meier PJ, and Brouwer KL (1999b) Biliary excretion in primary rat hepatocytes cultured in a collagen-sandwich configuration. Am J Physiol 277:G12-G21. (Pubitemid 29352640)
21. Muraoka I, Hasegawa T, Nadai M, Wang L, Haghgoo S, Tagaya O, and Nabeshima T (1995) Biliary and renal excretions of cefpiramide in Eisai hyperbilirubinemic rats. Antimicrob Agents Chemother 39:70-74.
22. Nakagomi-Hagihara R, Nakai D, Kawai K, Yoshigae Y, Tokui T, Abe T, and Ikeda T (2006) OATP1B1, OATP1B3, and mrp2 are involved in hepatobiliary transport of olmesartan, a novel angiotensin II blocker. Drug Metab Dispos 34:862-869.
23. Nakakariya M, Shimada T, Irokawa M, Koibuchi H, Iwanaga T, Yabuuchi H, Maeda T, and Tamai I (2008) Predominant contribution of rat organic anion transporting polypeptide-2 (Oatp2) to hepatic uptake of β-lactam antibiotics. Pharm Res 25:578-585. (Pubitemid 351357734)
24. Olsavsky KM, Page JL, Johnson MC, Zarbl H, Strom SC, and Omiecinski CJ (2007) Gene expression profiling and differentiation assessment in primary human hepatocyte cultures, established hepatoma cell lines, and human liver tissues. Toxicol Appl Pharmacol 222:42-56. (Pubitemid 46964871)
25. Rollins DE and Klaassen CD (1979) Biliary excretion of drugs in man. Clin Pharmacokinet 4:368-379. (Pubitemid 10235051)
26. Sasaki M, Suzuki H, Aoki J, Ito K, Meier PJ, and Sugiyama Y (2004) Prediction of in vivo biliary clearance from the in vitro transcellular transport of organic anions across a double-transfected Madin-Darby canine kidney II monolayer expressing both rat organic anion transporting polypeptide 4 and multidrug resistance associated protein 2. Mol Pharmacol 66:450-459. (Pubitemid 39329243)
27. Seglen PO (1976) Preparation of isolated rat liver cells. Methods Cell Biol 13:29-83.
28. Takayanagi M, Sano N, and Takikawa H (2005) Biliary excretion of olmesartan, an angiotensin II receptor antagonist, in the rat. J Gastroenterol Hepatol 20:784-788. (Pubitemid 40733376)
29. Talamini MA, Kappus B, and Hubbard A (1997) Repolarization of hepatocytes in culture. Hepatology 25:167-172. (Pubitemid 27015005)
30. Watanabe T, Kusuhara H, Maeda K, Kanamaru H, Saito Y, Hu Z, and Sugiyama Y (2010a) Investigation of the rate-determining process in the hepatic elimination of HMG-CoA reductase inhibitors in rats and humans. Drug Metab Dispos 38:215-222.
31. Watanabe T, Kusuhara H, and Sugiyama Y (2010b) Application of physiologically based pharmacokinetic modeling and clearance concept to drugs showing transporter-mediated distribution and clearance in humans. J Pharmacokinet Pharmacodyn 37:575-590.
32. Watanabe T, Maeda K, Kondo T, Nakayama H, Horita S, Kusuhara H, and Sugiyama Y (2009) Prediction of the hepatic and renal clearance of transporter substrates in rats using in vitro uptake experiments. Drug Metab Dispos 37:1471-1479.
33. Yamano K, Yamamoto K, Kotaki H, Takedomi S, Matsuo H, Sawada Y, and Iga T (1999) Correlation between in vivo and in vitro hepatic uptake of metabolic inhibitors of cytochrome P-450 in rats. Drug Metab Dispos 27:1225-1231.
34. Yamashiro W, Maeda K, Hirouchi M, Adachi Y, Hu Z, and Sugiyama Y (2006) Involvement of transporters in the hepatic uptake and biliary excretion of valsartan, a selective antagonist of the angiotensin II AT1-receptor, in humans. Drug Metab Dispos 34:1247-1254.
35. Zhang P, Tian X, Chandra P, and Brouwer KL (2005) Role of glycosylation in trafficking of Mrp2 in sandwich-cultured rat hepatocytes. Mol Pharmacol 67:1334-1341. (Pubitemid 40410434)