Literature DB >> 24637348

In vivo methods for drug absorption - comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects.

Erik Sjögren1, Bertil Abrahamsson2, Patrick Augustijns3, Dieter Becker4, Michael B Bolger5, Marcus Brewster6, Joachim Brouwers3, Talia Flanagan7, Matthew Harwood8, Christian Heinen9, René Holm10, Hans-Paul Juretschke11, Marlies Kubbinga12, Anders Lindahl13, Viera Lukacova5, Uwe Münster14, Sibylle Neuhoff8, Mai Anh Nguyen9, Achiel van Peer6, Christos Reppas15, Amin Rostami Hodjegan16, Christer Tannergren2, Werner Weitschies17, Clive Wilson18, Patricia Zane19, Hans Lennernäs1, Peter Langguth20.   

Abstract

This review summarizes the current knowledge on anatomy and physiology of the human gastrointestinal tract in comparison with that of common laboratory animals (dog, pig, rat and mouse) with emphasis on in vivo methods for testing and prediction of oral dosage form performance. A wide range of factors and methods are considered in addition, such as imaging methods, perfusion models, models for predicting segmental/regional absorption, in vitro in vivo correlations as well as models to investigate the effects of excipients and the role of food on drug absorption. One goal of the authors was to clearly identify the gaps in today's knowledge in order to stimulate further work on refining the existing in vivo models and demonstrate their usefulness in drug formulation and product performance testing.
Copyright © 2014 Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Bioavailability; Biopharmaceutic characterization; Drug product development; In vivo model selection

Mesh:

Substances:

Year:  2014        PMID: 24637348     DOI: 10.1016/j.ejps.2014.02.010

Source DB:  PubMed          Journal:  Eur J Pharm Sci        ISSN: 0928-0987            Impact factor:   4.384


  35 in total

1.  Exploring Canine-Human Differences in Product Performance. Part II: Use of Modeling and Simulation to Explore the Impact of Formulation on Ciprofloxacin In Vivo Absorption and Dissolution in Dogs.

Authors:  M N Martinez; B Mistry; V Lukacova; K A Lentz; J E Polli; S W Hoag; T Dowling; R Kona; R M Fahmy
Journal:  AAPS J       Date:  2017-03-06       Impact factor: 4.009

2.  Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic Models.

Authors:  Neil Mathias; Yan Xu; Balvinder Vig; Umesh Kestur; Amy Saari; John Crison; Divyakant Desai; Aditya Vanarase; Munir Hussain
Journal:  AAPS J       Date:  2015-05-02       Impact factor: 4.009

3.  Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling.

Authors:  Xuan Ding; Ivelina Gueorguieva; James A Wesley; Lee J Burns; Carrie A Coutant
Journal:  AAPS J       Date:  2015-07-01       Impact factor: 4.009

4.  Characterization of Contents of Distal Ileum and Cecum to Which Drugs/Drug Products are Exposed During Bioavailability/Bioequivalence Studies in Healthy Adults.

Authors:  Christos Reppas; Eleni Karatza; Constantinos Goumas; Constantinos Markopoulos; Maria Vertzoni
Journal:  Pharm Res       Date:  2015-05-22       Impact factor: 4.200

5.  "Development of Fixed Dose Combination Products" Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy.

Authors:  Bart Hens; Maura Corsetti; Marival Bermejo; Raimar Löbenberg; Pablo M González; Amitava Mitra; Divyakant Desai; Dakshina Murthy Chilukuri; Alexis Aceituno
Journal:  AAPS J       Date:  2019-06-06       Impact factor: 4.009

6.  Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process.

Authors:  Bipin Mistry; Nikunjkumar Patel; Masoud Jamei; Amin Rostami-Hodjegan; Marilyn N Martinez
Journal:  AAPS J       Date:  2016-06-16       Impact factor: 4.009

7.  Physicochemical Characterization and Biopharmaceutical Evaluation of ZWF: A Novel Anticancer Drug for the Treatment of Non-small Cell Lung Cancer.

Authors:  Lina Zhao; Li He; Yuan Chen; Tongchao Xia; Le Li; Shengyan Wang; Xu Bao; Junyi Yang
Journal:  AAPS PharmSciTech       Date:  2021-07-23       Impact factor: 3.246

8.  Modified release itraconazole amorphous solid dispersion to treat Aspergillus fumigatus: importance of the animal model selection.

Authors:  Julien P Maincent; Laura K Najvar; William R Kirkpatrick; Siyuan Huang; Thomas F Patterson; Nathan P Wiederhold; Jay I Peters; Robert O Williams
Journal:  Drug Dev Ind Pharm       Date:  2016-10-05       Impact factor: 3.225

9.  Characterization of Pharmacokinetics in the Göttingen Minipig with Reference Human Drugs: An In Vitro and In Vivo Approach.

Authors:  Floriane Lignet; Eva Sherbetjian; Nicole Kratochwil; Russell Jones; Claudia Suenderhauf; Michael B Otteneder; Thomas Singer; Neil Parrott
Journal:  Pharm Res       Date:  2016-07-28       Impact factor: 4.200

10.  Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin.

Authors:  Marilyn Martinez; Bipin Mistry; Viera Lukacova; Jim Polli; Stephen Hoag; Thomas Dowling; Ravikanth Kona; Raafat Fahmy
Journal:  AAPS J       Date:  2016-04-26       Impact factor: 4.009

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