Use of Sandwich-Cultured Human Hepatocytes to Predict Biliary Clearance of Angiotensin II Receptor Blockers and HMG-CoA Reductase Inhibitors
Previous reports have indicated that in vitro biliary clearance (Clbiliary) determined in sandwich-cultured hepatocytes correlates well with in vivo Clbiliary for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Clbiliary in sandwich-cultured human hepatocytes of...
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| Published in | Drug metabolism and disposition Vol. 37; no. 3; pp. 447 - 452 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
Bethesda, MD
Elsevier Inc
01.03.2009
American Society for Pharmacology and Experimental Therapeutics |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0090-9556 1521-009X 1521-009X |
| DOI | 10.1124/dmd.108.023465 |
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| Abstract | Previous reports have indicated that in vitro biliary clearance (Clbiliary) determined in sandwich-cultured hepatocytes correlates well with in vivo Clbiliary for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Clbiliary in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Clbiliary values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Clbiliary values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Clbiliary values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Clbiliary determined in sandwich-cultured human hepatocytes can be used to predict in vivo Clbiliary of compounds in humans. |
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| AbstractList | Previous reports have indicated that in vitro biliary clearance (Cl biliary ) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl biliary for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Cl biliary in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo
limited metabolism and 2) to compare the predicted Cl biliary values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic
Cl biliary values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were
35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Cl biliary values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based
on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion,
in vitro Cl biliary determined in sandwich-cultured human hepatocytes can be used to predict in vivo Cl biliary of compounds in humans. Previous reports have indicated that in vitro biliary clearance (Cl(biliary)) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl(biliary) for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Cl(biliary) in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Cl(biliary) values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Cl(biliary) values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Cl(biliary) values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Cl(biliary) determined in sandwich-cultured human hepatocytes can be used to predict in vivo Cl(biliary) of compounds in humans. Previous reports have indicated that in vitro biliary clearance (Clbiliary) determined in sandwich-cultured hepatocytes correlates well with in vivo Clbiliary for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Clbiliary in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Clbiliary values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Clbiliary values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Clbiliary values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Clbiliary determined in sandwich-cultured human hepatocytes can be used to predict in vivo Clbiliary of compounds in humans. Previous reports have indicated that in vitro biliary clearance (Cl biliary ) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl biliary for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Cl biliary in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Cl biliary values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Cl biliary values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Cl biliary values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Cl biliary determined in sandwich-cultured human hepatocytes can be used to predict in vivo Cl biliary of compounds in humans. Previous reports have indicated that in vitro biliary clearance (Cl(biliary)) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl(biliary) for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Cl(biliary) in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Cl(biliary) values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Cl(biliary) values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Cl(biliary) values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Cl(biliary) determined in sandwich-cultured human hepatocytes can be used to predict in vivo Cl(biliary) of compounds in humans.Previous reports have indicated that in vitro biliary clearance (Cl(biliary)) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl(biliary) for limited sets of compounds. The purpose of this study was 1) to determine the in vitro Cl(biliary) in sandwich-cultured human hepatocytes of angiotensin II receptor blockers and HMG-CoA reductase inhibitors that undergo limited metabolism and 2) to compare the predicted Cl(biliary) values with estimated in vivo hepatic clearance data in humans. The average biliary excretion index and in vitro intrinsic Cl(biliary) values of olmesartan, valsartan, pravastatin, rosuvastatin, and pitavastatin in sandwich-cultured human hepatocytes were 35, 23, 31, 25, and 16%, respectively, and 0.943, 1.20, 0.484, 3.39, and 5.48 ml/min/kg, respectively. Cl(biliary) values predicted from sandwich-cultured human hepatocytes correlated with estimated in vivo hepatic clearance values based on published data (no in vivo data in humans was available for pitavastatin), and the rank order was also consistent. In conclusion, in vitro Cl(biliary) determined in sandwich-cultured human hepatocytes can be used to predict in vivo Cl(biliary) of compounds in humans. |
| Author | Brouwer, Kim L.R. Bridges, Arlene S. Abe, Koji |
| AuthorAffiliation | School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina |
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| Author_xml | – sequence: 1 givenname: Koji surname: Abe fullname: Abe, Koji – sequence: 2 givenname: Arlene S. surname: Bridges fullname: Bridges, Arlene S. – sequence: 3 givenname: Kim L.R. surname: Brouwer fullname: Brouwer, Kim L.R. email: kbrouwer@unc.edu |
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| Copyright | 2009 American Society for Pharmacology and Experimental Therapeutics 2009 INIST-CNRS Copyright © 2009, The American Society for Pharmacology and Experimental Therapeutics |
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| Keywords | Human Biliary tract Cell culture Angiotensin II receptor Digestive system Liver Clearance In vitro Hepatocyte HMG-CoA reductase inhibitor Angiotensin antagonist Pharmacokinetics Predictive factor |
| Language | English |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Article, publication date, and citation information can be found at http://dmd.aspetjournals.org. ABBREVIATIONS: Clbiliary, biliary clearance; ARB, angiotensin II receptor blocker; CDFDA, 5 (and 6)-carboxy-2′,7′-dichlorofluorescein diacetate; CDF, 5 (and 6)-carboxy-2′,7′-dichlorofluorescein; HBSS, Hank's balanced salt solution; BEI, biliary excretion index; AUC, area under the medium concentration-time curve; MRP, multidrug resistance-associated protein; OATP, organic anion-transporting polypeptide. This work was supported by the National Institutes of Health National Institute of General Medical Sciences [Grant GM 41935]. doi:10.1124/dmd.108.023465. Address correspondence to: Dr. Kim L. R. Brouwer, University of North Carolina School of Pharmacy, Kerr Hall, CB#7360, Chapel Hill, NC 27599-7360. E-mail: kbrouwer@unc.edu |
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| Snippet | Previous reports have indicated that in vitro biliary clearance (Clbiliary) determined in sandwich-cultured hepatocytes correlates well with in vivo Clbiliary... Previous reports have indicated that in vitro biliary clearance (Cl biliary ) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl... Previous reports have indicated that in vitro biliary clearance (Cl(biliary)) determined in sandwich-cultured hepatocytes correlates well with in vivo... Previous reports have indicated that in vitro biliary clearance (Cl biliary ) determined in sandwich-cultured hepatocytes correlates well with in vivo Cl... |
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| SubjectTerms | Angiotensin II Type 1 Receptor Blockers - pharmacokinetics Area Under Curve Biliary Tract - metabolism Biological and medical sciences Cells, Cultured Hepatocytes - metabolism Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacokinetics Medical sciences Microscopy, Fluorescence Pharmacology. Drug treatments Short Communications |
| Title | Use of Sandwich-Cultured Human Hepatocytes to Predict Biliary Clearance of Angiotensin II Receptor Blockers and HMG-CoA Reductase Inhibitors |
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