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Intestinal Drug Absorption, Cytochrome P450 3A-Mediated

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Intestinal Drug Absorption, Cytochrome P450 3A-Mediated INTESTINAL DRUG ABSORPTION, CYTOCHROME P450 3A-MEDIATED METABOLISM, AND TRANSPORT AFTER SMALL BOWEL TRANSPLANTATION by Jennifer J. Bonner B.A., The College of Wooster, 1990 Pharm.D., University of Maryland, 2003 Submitted to the Graduate Faculty of The School of Pharmacy in partial fulfillment of the requirements for the degree of Doctor of Philosophy University of Pittsburgh 2012 ii UNIVERSITY OF PITTSBURGH SCHOOL OF PHARMACY This dissertation was presented by Jennifer J. Bonner It was defended on January 20 , 2012 and approved by Dissertation Advisor: Raman Venkataramanan, PhD, Professor, Department of Pharmaceutical Sciences Co-Advisor: Kareem Abu-Elmagd, MD, PhD, Professor, Department of Surgery Samuel Poloyac, PharmD, PhD, Associate Professor, Department of Pharmaceutical Sciences Robert Bies, PharmD, PhD, Associate Professor, Division of Clinical Pharmacology, Indiana University School of Medicine Charity Moore, PhD, Associate Professor, Department of Medicine Regis Vollmer, PhD, Professor, Department of Pharmaceutical Sciences iii Copyright © by Jennifer J. Bonner 2012 Soli Deo honor et gloria iv INTESTINAL DRUG ABSORPTION, CYTOCHROME P450 3A-MEDIATED METABOLISM, AND TRANSPORT AFTER SMALL BOWEL TRANSPLANTATION Jennifer J. Bonner University of Pittsburgh, 2012 ABSTRACT Small bowel allograft recipients require multiple medications after transplant, many of which are orally administered cytochrome P450 3A (CYP3A) and/or p-glycoprotein (p-gp) substrates. A previous study in dogs has shown that surgical manipulation of the intestine and ischemia-reperfusion injury lead to suppression of CYP3A and p-gp function in the early post- transplant period, presumably due to release of pro-inflammatory cytokines, a suppression that diminished over time. The work presented in this dissertation compares intestinal CYP3A (using midazolam) and p-gp (using fexofenadine) expression and function in small bowel transplant recipients in the early post-transplant period (the first 40 days after surgery, n=16) and later (four to 12 months) post transplant (n=10) as well as with age- and gender-matched (n=16) healthy control subjects. Oral AUC and oral bioavailability of midazolam were significantly higher in transplant subjects early post-transplant, but not different from controls at four to 12 months post- transplant. The oral AUC ratio of 1’hydroxymidazolam to midazolam, a measure of the extent of CYP3A-mediated metabolism, was significantly lower in the early post-transplant period compared with controls, but at the later period no difference was observed. No difference in v fexofenadine AUC was observed between subject groups, and although Tmax of fexofenadine was significantly higher in transplant subjects at both time periods compared with healthy controls, AUC and Cmax were more influenced by route of administration (jejunostomy tube vs. oral) and transplant subtype (modified multivisceral vs. isolated intestine) than by ileal ABCB1 expression. Dose-normalized AUC0-7 and Cmax of oral tacrolimus (a CYP3A/p-gp substrate) were significantly higher early post transplant compared with later. Overall this work presents strong evidence for an early immune-mediated suppression of intestinal CYP3A that eventually returns to normal in stable intestinal transplant patients, indicating that bioavailability of highly soluble, highly permeable CYP3A substrates such as midazolam will be significantly higher early post-transplant, requiring caution in their dosing during this time and by extrapolation, during other times of high immune activation, such as acute rejection. These findings have clinical relevance for appropriate medication use in small bowel transplant recipients. vi TABLE OF CONTENTS ACKNOWLEDGEMENTS ...................................................................................................XXV 1.0 INTRODUCTION ............................................................................................................... 1 1.1 FUNCTIONAL ANATOMY AND PHYSIOLOGY OF THE SMALL INTESTINE .......................................................................................................................... 1 1.1.1 Structure ........................................................................................................... 1 1.1.2 Gastrointestinal motility.................................................................................. 5 1.1.3 Gastrointestinal transit of pharmaceutical dosage forms ............................ 7 1.1.4 Drug absorption via the enterocyte ................................................................ 8 1.1.4.1 Solubility................................................................................................ 8 1.1.4.2 Paracellular absorption........................................................................ 8 1.1.4.3 Transcellular absorption and permeability........................................ 9 1.1.4.4 The Biopharmaceutic Classification System.................................... 11 1.1.5 Absorption via uptake transporters ............................................................. 13 1.1.5.1 Organic anion transporting polypeptides......................................... 14 1.1.5.2 Other uptake transporters................................................................. 14 1.1.6 Enterocyte barriers to absorption: Efflux transport and intestinal first- pass metabolism.......................................................................................................... 17 1.1.6.1 P-glycoprotein ..................................................................................... 18 vii 1.1.6.2 Breast cancer resistance protein (ABCG2) ...................................... 19 1.1.6.3 Multidrug resistance proteins............................................................ 19 1.1.6.4 Cytochrome P450 enzymes ................................................................ 20 1.1.6.5 UDP-glucuronosyltransferases .......................................................... 21 1.1.6.6 Other drug-metabolizing enzymes expressed in the enterocyte..... 21 1.1.6.7 The Biopharmaceutics Drug Disposition Classification System .... 22 1.2 INTESTINAL FAILURE ......................................................................................... 24 1.3 INTESTINAL TRANSPLANTATION ................................................................... 25 1.3.1 Isolated intestinal transplant graft drainage ............................................... 26 1.3.2 Medication use after small bowel transplantation ...................................... 28 1.4 EFFECTS OF SMALL BOWEL TRANSPLANTATION ON INTESTINAL FUNCTION AND ORAL DRUG DISPOSITION........................................................... 33 1.4.1 Extrinsic denervation of the intestine........................................................... 33 1.4.2 Severing of lymphatics................................................................................... 35 1.4.3 Changes in intestinal microflora................................................................... 37 1.4.4 Effects of intestinal manipulation................................................................. 38 1.4.5 Ischemia-reperfusion injury.......................................................................... 38 1.5 ANIMAL AND HUMAN STUDIES OF SMALL BOWEL TRANSPLANTATION...................................................................................................... 40 1.5.1 Vitamin deficiency after small bowel transplantation................................ 40 1.5.2 Effects of small bowel transplantation on intestinal smooth muscle contractility................................................................................................................. 40 viii 1.5.3 Gastric emptying and intestinal transit times after small bowel transplantation ........................................................................................................... 41 1.5.3.1 The MMC and postprandial motility after small bowel transplantation................................................................................................... 43 1.5.4 Immune activity after small bowel transplantation.................................... 43 1.5.5 Inflammatory mediator expression after small bowel transplantation .... 44 1.5.6 Effects of small bowel transplantation on CYP3A and p-gp expression and function ....................................................................................................................... 45 1.6 HYPOTHESIS AND SPECIFIC AIMS OF THIS RESEARCH.......................... 46 2.0 MATERIALS AND METHODS ...................................................................................... 52 2.1 STUDY DESIGN ....................................................................................................... 52 2.1.1 Subject recruitment – transplant subjects................................................... 52 2.1.2 Subject recruitment – control subjects ........................................................ 53 2.1.3 Study procedure ............................................................................................. 53 2.1.4 Ileal biopsy sampling in transplant subjects................................................ 55 2.2 MEASUREMENT OF MIDAZOLAM, 1’HYDROXYMIDAZOLAM, AND FEXOFENADINE IN PLASMA BY LC-MS .................................................................. 56 2.2.1 Materials ......................................................................................................... 56 2.2.2 Sample preparation.......................................................................................
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