Physiologically Based Oral Absorption Modelling to Study Gut-Level Drug Interactions

被引:7
作者
Chung, John [1 ]
Kesisoglou, Filippos [2 ]
机构
[1] Amgen Inc, Drug Prod Technol, Thousand Oaks, CA 91320 USA
[2] Merck & Co Inc, Biopharmaceut & Specialty Dosage Forms, Pharmaceut Sci & Clin Supply, West Point, PA 19486 USA
关键词
oral drug delivery; in silico modeling; cytochrome P450; drug interactions; food interactions; gastrointestinal transit; transporters; IN-VIVO; FORMULATION DEVELOPMENT; P-GLYCOPROTEIN; GASTRIC PH; WEAK BASES; FOOD; PHARMACOKINETICS; PREDICTION; IMPACT; VITRO;
D O I
10.1016/j.xphs.2017.08.015
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Physiologically based oral absorption models are in silico tools primarily used to guide formulation development and project the clinical performance of formulation variants. This commentary briefly discusses additional oral absorption model applications, focusing on gut-level drug interactions. Gutlevel drug interactions can involve drug degradation, metabolic enzymes, transporters, gastrointestinal motility modulators, acid-reducing agents, and food. The growth in publications reporting physiologically based oral absorption model utilization and successful pharmacokinetic prediction (e. g., after acidreducing agents or food coadministration) indicate that oral absorption models have achieved a level of maturity within the industry particularly over the past 15 years. Provided appropriate data and model validation, oral absorption modeling/ simulation may serve as a surrogate for clinical studies by providing both mechanistic and quantitative understanding of oral delivery considerations on pharmacokinetics. (c) 2018 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
引用
收藏
页码:18 / 23
页数:6
相关论文
共 38 条
  • [1] In Silico Modeling for the Nonlinear Absorption Kinetics of UK-343,664: A P-gp and CYP3A4 Substrate
    Abuasal, Bilal S.
    Bolger, Michael B.
    Walker, Don K.
    Kaddoumi, Amal
    [J]. MOLECULAR PHARMACEUTICS, 2012, 9 (03) : 492 - 504
  • [2] Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    Agoram, B
    Woltosz, WS
    Bolger, MB
    [J]. ADVANCED DRUG DELIVERY REVIEWS, 2001, 50 : S41 - S67
  • [3] SOLUBILITY AND ACID-BASE BEHAVIOR OF MIDAZOLAM IN MEDIA OF DIFFERENT PH, STUDIED BY ULTRAVIOLET SPECTROPHOTOMETRY WITH MULTICOMPONENT SOFTWARE
    ANDERSIN, R
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1991, 9 (06) : 451 - 455
  • [4] Mechanistic investigation of the negative food effect of modified release zolpidem
    Andreas, Cord J.
    Pepin, Xavier
    Markopoulos, Constantinos
    Vertzoni, Maria
    Reppas, Christos
    Dressman, Jennifer B.
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2017, 102 : 284 - 298
  • [5] Prediction of the disposition of midazolam in surgical patients by a physiologically based pharmacokinetic model
    Björkman, S
    Wada, DR
    Berling, BM
    Benoni, G
    [J]. JOURNAL OF PHARMACEUTICAL SCIENCES, 2001, 90 (09) : 1226 - 1241
  • [6] Utilizing Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility
    Chung, John
    Alvarez-Nunez, Fernando
    Chow, Vincent
    Daurio, Dominick
    Davis, John
    Dodds, Michael
    Emery, Maurice
    Litwiler, Kevin
    Paccaly, Anne
    Peng, Joanna
    Rock, Brooke
    Wienkers, Larry
    Yang, Charles
    Yu, Zhigang
    Wahlstrom, Jan
    [J]. JOURNAL OF PHARMACEUTICAL SCIENCES, 2015, 104 (04) : 1522 - 1532
  • [7] Differences in Food Effects for 2 Weak Bases With Similar BCS Drug-Related Properties: What Is Happening in the Intestinal Lumen?
    Cristofoletti, Rodrigo
    Patel, Nikunjkumar
    Dressman, Jennifer B.
    [J]. JOURNAL OF PHARMACEUTICAL SCIENCES, 2016, 105 (09) : 2712 - 2722
  • [8] Viscosity-mediated negative food effect on oral absorption of poorly-permeable drugs with an absorption window in the proximal intestine: In vitro experimental simulation and computational verification
    Cvijic, Sandra
    Parojcic, Jelena
    Langguth, Peter
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2014, 61 : 40 - 53
  • [9] IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes
    Darwich, Adam S.
    Margolskee, Alison
    Pepin, Xavier
    Aarons, Leon
    Galetin, Aleksandra
    Rostami-Hodjegan, Amin
    Carlert, Sara
    Hammarberg, Maria
    Hilgendorf, Constanze
    Johansson, Pernilla
    Karlsson, Eva
    Murphy, Donal
    Tannergren, Christer
    Thorn, Helena
    Yasin, Mohammed
    Mazuir, Florent
    Nicolas, Olivier
    Ramusovic, Sergej
    Xu, Christine
    Pathak, Shriram M.
    Korjamo, Timo
    Laru, Johanna
    Malkki, Jussi
    Pappinen, Sari
    Tuunainen, Johanna
    Dressman, Jennifer
    Hansmann, Simone
    Kostewicz, Edmund
    He, Handan
    Heimbach, Tycho
    Wu, Fan
    Hoft, Carolin
    Pang, Yan
    Bolger, Michael B.
    Huehn, Eva
    Lukacova, Viera
    Mullin, James M.
    Szeto, Ke X.
    Costales, Chester
    Lin, Jian
    McAllister, Mark
    Modi, Sweta
    Rotter, Charles
    Varma, Manthena
    Wong, Mei
    Mitra, Amitava
    Bevernage, Jan
    Biewenga, Jeike
    Van Peer, Achiel
    Lloyd, Richard
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2017, 96 : 626 - 642
  • [10] Drug-Drug Interactions Mediated Through P-Glycoprotein: Clinical Relevance and In Vitro-In Vivo Correlation Using Digoxin as a Probe Drug
    Fenner, K. S.
    Troutman, M. D.
    Kempshall, S.
    Cook, J. A.
    Ware, J. A.
    Smith, D. A.
    Lee, C. A.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 85 (02) : 173 - 181