Evidence map›Paper›PMID 42893118›Full record

ArticleInternational journal of pharmaceutics: X2026

Applicability of a miniaturized precipitation assay as an early-stage screening tool for prototype formulation development.

Sara Mayer, Katharina Krollik, Christian Wagner, Andreas Lehmann, Jacob Spanheimer, Werner Weitschies

Abstract read
In one paragraph

Article in International journal of pharmaceutics: X, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Sara MayerInstitute of Pharmacy, Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Felix-Hausdorff-Straße 3, 17489 Greifswald, Germany.
Katharina KrollikGlobal Drug Product Development, Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
Christian WagnerGlobal Drug Product Development, Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
Andreas LehmannGlobal Drug Product Development, Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
Jacob SpanheimerGlobal Drug Product Development, Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
Werner WeitschiesInstitute of Pharmacy, Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Felix-Hausdorff-Straße 3, 17489 Greifswald, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Poor aqueous solubility is a frequently faced challenge in oral drug development. Therefore, the development of predictive in vitro tools for the selection of a suitable formulation is essential. For early formulation development, such an assay ideally requires minimal resources. To address this need, we evaluated the benefits of a previously published miniaturized two-compartment precipitation assay to assess formulation effects early in drug product development. The assay was originally developed for screening compounds for their absorption behavior during preclinical stage. Six poorly soluble weakly basic compounds (albendazole, ibrutinib, itraconazole, posaconazole, ritonavir, ziprasidone; two formulations each) and one poorly soluble neutral compound (fenofibrate; three formulations) were tested under simulated fasted conditions. Formulation differences found in vitro were compared to human pharmacokinetic data obtained from literature. From a qualitative perspective, the assay correctly reflected the in vivo observations for five out of the six basic compounds, as well as for fenofibrate. Quantitatively, the assay approximated the observed in vivo formulation effects for several compounds, including itraconazole, posaconazole, ritonavir, ziprasidone and fenofibrate, whereas the effect size was overestimated for albendazole and ibrutinib, likely reflecting potential assay limitations. These findings support the use of the miniaturized precipitation assay as a fit-for-purpose screening tool for early formulation development.

Indexed as

Absorption predictionsBasic compoundsIntestinal absorptionIn vitro-in vivo correlationPrecipitation assayPrototype formulation development

Identifiers

PMID42893118
PMCPMC13675896

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.