Evidence map›Paper›PMID 35501614›Full record

ReviewThe AAPS journal2022

A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption.

Marilyn N Martinez, Balint Sinko, Fang Wu, Talia Flanagan, Enikő Borbás, Eleftheria Tsakalozou, Kathleen M Giacomini

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Article
  2. Article
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  4. Article
  5. Review
  6. Article
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

7 authors.

Marilyn N MartinezOffice of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA), Rockville, Maryland, USA. marilyn.martinez@fda.hhs.gov.ORCID http://orcid.org/0000-0002-4512-853X
Balint SinkoPion Inc, Billerica, Maryland, USA.
Fang WuDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, Maryland, USA.
Talia FlanaganUCB Pharma S.A. Allée de la Recherche, 60 1070, Brussels, Belgium.
Enikő BorbásDepartment of Organic Chemistry and Technology, Budapest University of Technology and Economics, 3 Muegyetem rakpart, Budapest, 1111, Hungary.
Eleftheria TsakalozouDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, Maryland, USA.
Kathleen M GiacominiDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Traditionally, excipients have been considered in drug development from the perspective of their influence on drug solubility, manufacturability, and ability to control in vitro and in vivo drug release. These effects have been largely evaluated through studies involving in vitro dissolution methods. However, there is a growing awareness that what had previously been considered biologically inert excipients can exert numerous in vivo effects. This includes the potential to change gastrointestinal (GI) transit time, enterocyte passive transcellular or paracellular permeability, active transport activity, or presystemic drug metabolism. In this critical overview of the biological effects of excipients (Part I), we provide a summary of select published studies that explore these various in vivo factors. We also include a table that points readers to published reviews that list a range of excipients known to have biological activity. A subsequent discussion on in vitro, in vivo, and in silico methods that can be used to explore these excipient effects is provided in a separate (Part 2) continuation of this critical overview.

Indexed as

ExcipientsIntestinal AbsorptionPermeabilitySolubilityExcipientsactive transportdrug metabolismexcipient effectsGI transit timemembrane permeability

Identifiers

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.