Evidence map›Paper›PMID 31156945›Full record

ArticleEuropean journal of hospital pharmacy : science and practice2017

A stability study of amphotericin B, colistin and tobramycin in a hydrophilic suspension commonly used for selective decontamination of the digestive tract by HPLC and in vitro potency measurements.

Corina Pfeifer, Sylvia Noll, Hagen Gerecke, Georg Fassauer, Thomas Jira, Yvonne Remane, Jan Vogel, Roberto Frontini, Robert Reinhardt

Open access · greenAbstract read
In one paragraph

Article in European journal of hospital pharmacy : science and practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact, top 95% 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

4 citing papers in PubMed, 3 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

9 authors at 3 institutions in 1 country.

Corina PfeiferDevelopment Department, mibe GmbH Arzneimittel, Brehna, Germany.
Sylvia NollDevelopment Department, mibe GmbH Arzneimittel, Brehna, Germany.
Hagen GereckeDevelopment Department, mibe GmbH Arzneimittel, Brehna, Germany.
Georg FassauerInstitute of Pharmacy, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Germany.
Thomas JiraInstitute of Pharmacy, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Germany.
Yvonne RemaneHospital Pharmacy, University of Leipzig, Leipzig, Germany.
Jan VogelHospital Pharmacy, University of Leipzig, Leipzig, Germany.
Roberto FrontiniHospital Pharmacy, University of Leipzig, Leipzig, Germany.
Robert ReinhardtDevelopment Department, mibe GmbH Arzneimittel, Brehna, Germany.
Dr. Pfleger Arzneimittel (Germany) · DEUniversity Hospital Leipzig · DEUniversität Greifswald · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesA suspension for oral use which consists of three non-absorbable antibiotics (amphotericin B, colistin and tobramycin) is often used in clinical practice for the selective decontamination of the digestive tract (SDD) of patients in intensive care. Such a therapy is a preventive tool to minimise the risk of pneumonia and bacteraemia in intubated patients. The administration and the treatment results are controversially discussed. One limiting factor for a unique SDD treatment in the hospitals is a lack of adequate data regarding batch formula and stability for such a formulation. Since no detailed procedures, specifications or stability data are available for manufacturing this formulation there may be discrepancies regarding formulation and stability of suspensions prepared in different pharmacies. The aim of this research was to collect the physicochemical and microbiological stability data of a developed, stable standard formulation under defined storage conditions. The effectiveness of the SDD suspension should be preferably proven over a long period. This would help guarantee that all patients receive the same preparation, therefore, ensuring similar efficacy and improved safety.

methodsAn adequate formulation composed of the registered, marketed medicinal product

resultsThe results show the physicochemical and microbiological stability of the described formulation for defined storage conditions.

conclusionsA standardised formulation with a proven stability for at least 6 months under fridge (5°C±3°C) conditions for the SDD of patients in intensive care was established.

Identifiers

PMID31156945
PMCPMC6451449
OpenAlexW2503808805

What OpenQuestion holds

Textmetadata
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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.