Evidence map›Paper›PMID 36559103›Full record

ArticlePharmaceutics2022

An In Vitro Model to Investigate the Potential of Solid Dispersions to Form Pharmacobezoars.

Hannes Gierke, Kerstin Schaefer, Lukas Gerlich, Ann-Cathrin Willmann, Verena Bialetzki, Georg Boeck, Teresa Pfrommer, Thomas Nolte, Werner Weitschies

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 64% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

9 authors at 3 institutions in 2 countries.

Hannes GierkeDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, University of Greifswald, 17489 Greifswald, Germany.ORCID 0000-0002-4639-0425
Kerstin SchaeferBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.
Lukas GerlichDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, University of Greifswald, 17489 Greifswald, Germany.
Ann-Cathrin WillmannBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.ORCID 0000-0001-5859-1315
Verena BialetzkiBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.
Georg BoeckBoehringer Ingelheim Pharma GmbH & Co. KG, 1120 Vienna, Austria.
Teresa PfrommerBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.
Thomas NolteBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.
Werner WeitschiesDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, University of Greifswald, 17489 Greifswald, Germany.ORCID 0000-0003-3492-7747
Boehringer Ingelheim (Germany) · DEUniversität Greifswald · DEBoehringer Ingelheim (Austria) · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The formation of pharmacobezoars from suspensions of spray-dried amorphous solid dispersions (SD-ASDs) of new chemical entities (NCEs) and hydroxypropyl methylcellulose acetate succinate (HPMC-AS) represents a non-compound related adverse effect in preclinical oral toxicity studies in rodents. Whereas the contribution of the insolubility of the carrier polymer to this process taking place in the acidic environment of the rodent stomach is conclusive, unawareness of the extent of in vivo pharmacobezoar formation is adverse. In order to evaluate the risk of pharmacobezoar formation before in vivo administration, we subsequently introduce an in vitro model to assess the agglomeration potential of solid dispersions. To verify that the pharmacobezoar formation potential can be assessed based on the observed agglomeration potential, we conducted a sequence of experiments with two HPMC-AS-based SD-ASD formulations. In vitro, we found their different in vivo pharmacobezoar formation potential reflected by a significantly increased agglomerated mass of formulation 1 per day compared to formulation 2. In order to find an approach to reduce the agglomeration potential of solid dispersion from suspensions, we further applied the model to investigate the impact of the viscosity of the vehicle used to prepare suspensions on agglomerate formation.

Indexed as

in vitro modelpharmacobezoarspreclinical testingrodent stomachspray dried amorphous solid dispersions

Identifiers

PMID36559103
PMCPMC9785156
OpenAlexW4310214775

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Registered trials

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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.