Prediction of clinically relevant herb-drug clearance interactions using sandwich-cultured human hepatocytes: Schisandra spp. case study

Drug Metabolism and Disposition

Volumn 45, Issue 9, 2017, Pages 1019-1026

  Jackson, Jonathan P ^a   Freeman, Kimberly M ^a   Friley, Weslyn W ^a   Herman, Ashley G ^a   Black, Christopher B ^a   Brouwer, Kenneth R ^a   Roe, Amy L ^b  

^a Qualyst Transporter Solutions   (United States)

^b PROCTER AND GAMBLE COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONSTITUTIVE ANDROSTANE RECEPTOR; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; MESSENGER RNA; MIDAZOLAM; PLANT EXTRACT; PREGNANE X RECEPTOR; SCHISANDRA SPHENANTHERA EXTRACT; UNCLASSIFIED DRUG; LIGNAN;

ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DRUG CLEARANCE; DRUG CYTOTOXICITY; DRUG EXPOSURE; DRUG METABOLISM; DRUG TRANSPORT; ENZYME INDUCTION; ENZYME INHIBITION; FRUIT; HERB DRUG INTERACTION; HUMAN; HUMAN CELL; IN VITRO STUDY; LIVER CELL CULTURE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RETROSPECTIVE STUDY; SANDWICH CULTURED HUMAN HEPATOCYTE; SCHISANDRA; SCHISANDRA SPHENANTHERA; SIGNAL TRANSDUCTION; CELL CULTURE; CHEMISTRY; CYTOLOGY; LIVER CELL; METABOLISM;

CELLS, CULTURED; HEPATOCYTES; HERB-DRUG INTERACTIONS; HUMANS; LIGNANS; MIDAZOLAM; PLANT EXTRACTS; SCHISANDRA;

EID: 85029295799     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.117.075408     Document Type: Article

References (29)

1. Backman JT, Olkkola KT, and Neuvonen PJ (1996) Rifampin drastically reduces plasma concentrations and effects of oral midazolam. Clin Pharmacol Ther 59:7–13.
2. Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, et al.; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups (2003) The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective. J Clin Pharmacol 43:443–469.
3. Brown HS, Chadwick A, and Houston JB (2007) Use of isolated hepatocyte preparations for cytochrome P450 inhibition studies: comparison with microsomes for Ki determination. Drug Metab Dispos 35:2119–2126.
4. Chandra P and Brouwer KL (2004) The complexities of hepatic drug transport: current knowledge and emerging concepts. Pharm Res 21:719–735.
5. Davies B and Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–1095.
6. Dickinson A, Blatman J, El-Dash N, and Franco JC (2014) Consumer usage and reasons for using dietary supplements: report of a series of surveys. J Am Coll Nutr 33:176–182.
7. Essigmann JM, Croy RG, Nadzan AM, Busby WF Jr, Reinhold VN, Büchi G, and Wogan GN (1977) Structural identification of the major DNA adduct formed by aflatoxin B1 in vitro. Proc Natl Acad Sci USA 74:1870–1874.
8. European Medicines Agency (2012) Guideline on the Investigation of Drug Interactions, European Medicines Agency, London.
9. Fahmi OA, Kish M, Boldt S, and Obach RS (2010) Cytochrome P450 3A4 mRNA is a more reliable marker than CYP3A4 activity for detecting pregnane X receptor-activated induction of drug-metabolizing enzymes. Drug Metab Dispos 38:1605–1611.
10. Food and Drug Administration (2006) Draft Guidance for Industry - Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling, Food and Drug Administration Publication, Silver Spring, MD.
11. Food and Drug Administration (2012) Draft Guidance for Industry - Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling, Food and Drug Administration Publication, Silver Spring, MD.
12. Ghibellini G, Vasist LS, Leslie EM, Heizer WD, Kowalsky RJ, Calvo BF, and Brouwer KLR (2007) In vitro-in vivo correlation of hepatobiliary drug clearance in humans. Clin Pharmacol Ther 81:406–413.
13. Gurley BJ (2012) Pharmacokinetic herb-drug interactions (part 1): origins, mechanisms, and the impact of botanical dietary supplements. Planta Med 78:1478–1489.
14. Hewitt NJ, Lechón MJG, Houston JB, Hallifax D, Brown HS, Maurel P, Kenna JG, Gustavsson L, Lohmann C, Skonberg C, et al. (2007) Primary hepatocytes: current understanding of the regulation of metabolic enzymes and transporter proteins, and pharmaceutical practice for the use of hepatocytes in metabolism, enzyme induction, transporter, clearance, and hepatotoxicity studies. Drug Metab Rev 39:159–234.
15. Iwata H, Tezuka Y, Usia T, Kadota S, Hiratsuka A, and Watabe T (2004) Inhibition of human liver microsomal CYP3A4 and CYP2D6 by extracts from 78 herbal medicines. J Trad Med 21:42–50.
16. Jackson JP, Kabirov KK, Kapetanovic IM, and Lyubimov A (2009) In vitro assessment of P450 induction potential of novel chemopreventive agents SR13668, 9-cis-UAB30, and pentamethychromanol in primary cultures of human hepatocytes. Chem Biol Interact 179:263–272.
17. Jou J and Johnson PJ (2016) Nondisclosure of complementary and alternative medicine use to primary care physicians: findings from the 2012 National Health Interview Survey. JAMA Intern Med 176:545–546.
18. Lee JK and Brouwer KR (2010) Determination of intracellular volume of rat and human sandwich-cultured hepatocytes (Abstract). The Toxicologist Toxicol Sci 114 (Suppl):339.
19. Liu X, Chism JP, LeCluyse EL, Brouwer KR, and Brouwer KLR (1999) Correlation of biliary excretion in sandwich-cultured rat hepatocytes and in vivo in rats. Drug Metab Dispos 27: 637–644.
20. Marion TL, Perry CH, St Claire RL, III, and Brouwer KLR (2012) Endogenous bile acid disposition in rat and human sandwich-cultured hepatocytes. Toxicol Appl Pharmacol 261:1–9.
21. McGinnity DF, Tucker J, Trigg S, and Riley RJ (2005) Prediction of CYP2C9-mediated drug-drug interactions: a comparison using data from recombinant enzymes and human hepatocytes. Drug Metab Dispos 33:1700–1707.
22. Qin XL, Bi HC, Wang XD, Li JL, Wang Y, Xue XP, Chen X, Wang CX, Xu J, Wang YT, et al. (2010) Mechanistic understanding of the different effects of Wuzhi Tablet (Schisandra sphenanthera extract) on the absorption and first-pass intestinal and hepatic metabolism of Tacrolimus (FK506). Int J Pharm 389:114–121.
23. Roe AL, Paine MF, Gurley BJ, Brouwer KR, Jordan S, and Griffiths JC (2016) Assessing natural product-drug interactions: an end-to-end safety framework. Regul Toxicol Pharmacol 76:1–6.
24. Smith T, Kawa K, Eckl V, and Johnson J (2016) Sales of herbal dietary supplements in US increased 7.5% in 2015. HerbalGram 111:67–73.
25. Sprouse AA and van Breemen RB (2016) Pharmacokinetic interactions between drugs and botanical dietary supplements. Drug Metab Dispos 44:162–171.
26. Wang Z, Gorski JC, Hamman MA, Huang SM, Lesko LJ, and Hall SD (2001) The effects of St John’s wort (Hypericum perforatum) on human cytochrome P450 activity. Clin Pharmacol Ther 70:317–326.
27. Xin HW, Wu XC, Li Q, Yu AR, Zhu M, Shen Y, Su D, and Xiong L (2007) Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers. Br J Clin Pharmacol 64:469–475.
28. Xin HW, Wu XC, Li Q, Yu AR, and Xiong L (2009) Effects of Schisandra sphenanthera extract on the pharmacokinetics of midazolam in healthy volunteers. Br J Clin Pharmacol 67:541–546.
29. Zanger UM and Schwab M (2013) Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther 138: 103–141.