Evidence map›Paper›PMID 37896157›Full record

ReviewPharmaceutics2023

Challenges in Permeability Assessment for Oral Drug Product Development.

Mirko Koziolek, Patrick Augustijns, Constantin Berger, Rodrigo Cristofoletti, David Dahlgren, Janneke Keemink, Pär Matsson, Fiona McCartney, Marco Metzger, Mario Mezler and 5 more

Open access · goldAbstract readReview
In one paragraph

Review in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 7 countries.

Mirko KoziolekNCE Drug Product Development, Development Sciences, AbbVie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany.ORCID 0000-0002-1385-182X
Patrick AugustijnsDrug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.ORCID 0000-0003-2595-388X
Constantin BergerChair of Tissue Engineering and Regenerative Medicine, University Hospital Würzburg, 97070 Würzburg, Germany.
Rodrigo CristofolettiDepartment of Pharmaceutics, University of Florida, 6550 Sanger Road, Orlando, FL 32827, USA.
David DahlgrenDepartment of Pharmaceutical Biosciences, Uppsala University, 75124 Uppsala, Sweden.ORCID 0000-0002-5586-2906
Janneke KeeminkRoche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche AG, 4070 Basel, Switzerland.ORCID 0009-0006-7359-5350
Pär MatssonDepartment of Pharmacology and SciLifeLab Gothenburg, University of Gothenburg, 40530 Gothenburg, Sweden.ORCID 0000-0002-9094-2581
Fiona McCartneySchool of Veterinary Medicine, University College Dublin, D04 V1W8 Dublin, Ireland.ORCID 0000-0002-5834-7950
Marco MetzgerTranslational Center for Regenerative Therapies (TLZ-RT) Würzburg, Branch of the Fraunhofer Institute for Silicate Research (ISC), 97082 Würzburg, Germany.
Mario MezlerQuantitative, Translational & ADME Sciences, AbbVie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany.ORCID 0000-0002-7253-0962
Janis NiessenDepartment of Pharmaceutical Biosciences, Uppsala University, 75124 Uppsala, Sweden.
James E PolliDepartment of Pharmaceutical Sciences, University of Maryland, Baltimore, MD 21021, USA.ORCID 0000-0002-5274-4314
Maria VertzoniDepartment of Pharmacy, National and Kapodistrian University of Athens, 157 84 Zografou, Greece.ORCID 0000-0003-4463-2459
Werner WeitschiesInstitute of Pharmacy, University of Greifswald, 17489 Greifswald, Germany.ORCID 0000-0003-3492-7747
Jennifer DressmanFraunhofer Institute of Translational Medicine and Pharmacology, 60596 Frankfurt, Germany.
AbbVie (Germany) · DEUppsala University · SEFraunhofer Institute for Silicate Research · DEFraunhofer Institute for Translational Medicine and Pharmacology · DEKU Leuven · BENational and Kapodistrian University of Athens · GRRoche (Switzerland) · CHScience for Life Laboratory · SEUniversität Greifswald · DEUniversitätsklinikum Würzburg · DEUniversity College Dublin · IEUniversity of Florida · USUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug permeation across the intestinal epithelium is a prerequisite for successful oral drug delivery. The increased interest in oral administration of peptides, as well as poorly soluble and poorly permeable compounds such as drugs for targeted protein degradation, have made permeability a key parameter in oral drug product development. This review describes the various in vitro, in silico and in vivo methodologies that are applied to determine drug permeability in the human gastrointestinal tract and identifies how they are applied in the different stages of drug development. The various methods used to predict, estimate or measure permeability values, ranging from in silico and in vitro methods all the way to studies in animals and humans, are discussed with regard to their advantages, limitations and applications. A special focus is put on novel techniques such as computational approaches, gut-on-chip models and human tissue-based models, where significant progress has been made in the last few years. In addition, the impact of permeability estimations on PK predictions in PBPK modeling, the degree to which excipients can affect drug permeability in clinical studies and the requirements for colonic drug absorption are addressed.

Indexed as

drug absorptionin silicoin vitroin vivooral drug deliverypermeability

Identifiers

PMID37896157
PMCPMC10609725
OpenAlexW4387136324

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.