Evidence map›Paper›PMID 32825121›Full record

ArticlePharmaceutics2020

Do Ophthalmic Solutions of Amphotericin B Solubilised in 2-Hydroxypropyl-γ-Cyclodextrins Possess an Extended Physicochemical Stability?

Philip Chennell, Mouloud Yessaad, Florence Abd El Kader, Mireille Jouannet, Mathieu Wasiak, Yassine Bouattour, Valérie Sautou

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Philip ChennellUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont-Ferrand, ICCF, 63000 Clermont-Ferrand, France.ORCID 0000-0001-8086-7517
Mouloud YessaadCHU Clermont-Ferrand, Pôle Pharmacie, 63000 Clermont-Ferrand, France.
Florence Abd El KaderCHU Clermont-Ferrand, Pôle Pharmacie, 63000 Clermont-Ferrand, France.
Mireille JouannetCHU Clermont-Ferrand, Pôle Pharmacie, 63000 Clermont-Ferrand, France.
Mathieu WasiakCHU Clermont-Ferrand, Pôle Pharmacie, 63000 Clermont-Ferrand, France.
Yassine BouattourUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont-Ferrand, ICCF, 63000 Clermont-Ferrand, France.ORCID 0000-0002-6937-1796
Valérie SautouUniversité Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont-Ferrand, ICCF, 63000 Clermont-Ferrand, France.ORCID 0000-0002-3944-3752
Centre Hospitalier Universitaire de Clermont-Ferrand · FRCentre National de la Recherche Scientifique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fungal keratitis is a sight-threatening disease for which amphotericin B eye drops is one of the front-line treatments. Unfortunately, there are currently no commercial forms available, and there is little data concerning the long-term stability of compounded formulations based on intravenous dosages forms. New formulations of amphotericin B ophthalmic solutions solubilised with γ-cyclodextrins have shown promising in-vitro results, but stability data is also lacking. The objective of this study was therefore to investigate the stability of a formulation of ready-to-use amphotericin B solubilised in 2-hydroxypropyl-γ-cyclodextrins (AB-HP-γ-CD), for 350 days. An amphotericin B deoxycholate (ABDC) formulation was used as a comparator. Analyses used were the following: visual inspection, turbidity, osmolality and pH measurements, amphotericin B quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. AB-HP-γ-CD formulation showed signs of chemical instability (loss of amphotericin B) after 28 and 56 days at 25 °C and 5 °C. Adding an antioxidant (ascorbic acid) to the formulation did not improve stability. ABDC formulation showed signs of physical instability (increased turbidy and amphotericin B precipitation) after 28 days and 168 days at 25 °C and 5 °C. As such, AB-HP-γ-CD formulation does not provide long-term stability for ophthalmic amphotericin B solutions.

Indexed as

amphotericin Bfungal keratitisstabilityγ-cyclodextrins

Identifiers

PMID32825121
PMCPMC7559369
OpenAlexW3079070284

What OpenQuestion 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 OpenQuestion graph.