Evidence map›Paper›PMID 38750299›Full record

ArticleAAPS PharmSciTech2024

Accelerative Solid-State Oxidation Behaviour of Amorphous and Partially Crystalline Venetoclax.

Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Bernd Werner, Klaus Zangger, Isha Saraf, Amrit Paudel, Varun Kushwah

Abstract read
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Article in AAPS PharmSciTech, 2024. 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
–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

1 citing paper in PubMed.

  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

8 authors.

Jesús Alberto Afonso UrichResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria.
Viktoria MarkoResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria.
Katharina BoehmResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria.
Bernd WernerInstitute of Chemistry, University of Graz, Heinrichstr. 28, 8010, Graz, Austria.
Klaus ZanggerInstitute of Chemistry, University of Graz, Heinrichstr. 28, 8010, Graz, Austria.
Isha SarafResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria.
Amrit PaudelResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria. amrit.paudel@rcpe.at.
Varun KushwahResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria. varun.kushwah@rcpe.at.ORCID http://orcid.org/0000-0002-0636-6674

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a growing focus on solid-state degradation, especially for its relevance in understanding interactions with excipients. Performing a solid-state degradation of Venetoclax (VEN), we delve into VEN's stability in different solid-state oxidative stress conditions, utilizing Peroxydone™ complex and urea peroxide (UHP). The investigation extends beyond traditional forced degradation scenarios, providing insights into VEN's behavior over 32 h, considering temperature and crystallinity conditions. Distinct behaviors emerge in the cases of Peroxydone™ complex and UHP. The partially crystalline (PC-VEN) form proves more stable with Peroxydone™, while the amorphous form (A-VEN) shows enhanced stability with UHP. N-oxide VEN, a significant degradation product, varies between these cases, reflecting the impact of different oxidative stress conditions. Peroxydone™ complex demonstrates higher reproducibility and stability, making it a promising option for screening impurities in solid-state oxidative stress scenarios. This research not only contributes to the understanding of VEN's stability in solid-state but also aids formulators in anticipating excipient incompatibilities owing to presence of reactive impurities (peroxides) and oxidation in the final dosage form.

Indexed as

Bridged Bicyclo Compounds, HeterocyclicCrystallizationDrug StabilityExcipientsOxidation-ReductionSulfonamidesChemistry, PharmaceuticalOxidative StressTemperatureBridged Bicyclo Compounds, HeterocyclicExcipientsSulfonamidesdegradation productsoxidative stress studypharmaceutical stabilitysolid state degradation

Identifiers

What OpenQuestion holds

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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.