Evidence map›Paper›PMID 34584403›Full record

ArticleDrug design, development and therapy2021

Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site.

Sarah Fawaz, Mahboub Merzouk, Stephen Barton, Shereen Nabhani-Gebara

Open access · goldAbstract readComparative Study
In one paragraph

Article in Drug design, development and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 13 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

4 authors at 1 institution in 1 country.

Sarah FawazFaculty of Science, Engineering and Computing, Kingston University, London, UK.ORCID 0000-0001-6756-5450
Mahboub MerzoukFaculty of Science, Engineering and Computing, Kingston University, London, UK.ORCID 0000-0001-5289-2627
Stephen BartonFaculty of Science, Engineering and Computing, Kingston University, London, UK.ORCID 0000-0002-9661-8416
Shereen Nabhani-GebaraFaculty of Science, Engineering and Computing, Kingston University, London, UK.ORCID 0000-0002-5784-4779
Kingston University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleWith the discovery of new antibiotics diminishing, optimising the administration of existing antibiotics such as amoxicillin-clavulanic acid has become a necessity. At present, the optimal approach for enhancing the effectiveness of time-dependent antibiotics involves extending the time at which antibiotic concentrations are maintained above the minimal inhibitory concentration by prolonging the infusion time. This pharmacodynamic rationale cannot be applied to co-amoxiclav because of poor stability at room temperature. The aim of this study was to establish the shelf-life of amoxicillin and clavulanic acid prepared in separate containers to determine the feasibility of 24-hr continuous infusion therapy.

methodsA previously developed and validated stability-indicating HPLC method was used to establish the shelf-life of reconstituted amoxicillin and clavulanic acid when prepared in separate containers. Stability at clinical concentration was evaluated at three temperatures. To establish whether there were significant differences at the level of both active ingredients and temperature, results were analysed using analysis of covariance (ANCOVA) to assess differences between the attained slopes of regression.

resultsData obtained indicated amoxicillin and clavulanic acid stability superior to that previously proposed making it suitable for continuous infusion therapy. Analysis of regression slopes via ANCOVA showed that temperature significantly affected amoxicillin and clavulanic acid stability. Amoxicillin retained 90% of its initial concentration for 80.3 hrs when stored at 4°C, 24.8 hrs at 25°C and 9 hrs when incubated at 37°C. Clavulanic acid retained 90% of its initial concentration for 152 hrs when stored at 4°C, 26 hrs at 25°C and 6.4 hrs when incubated at 37°C.

conclusionAmoxicillin and clavulanic acid are suitable for administration via continuous infusion when prepared, stored, and administered in separate containers. Results obtained from this study aid in ameliorating current dosing regimens to optimise antibiotic efficacy; however, more in-depth amoxicillin and clavulanic acid y-site compatibility studies are warranted.

Indexed as

Amoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsChemistry, PharmaceuticalChromatography, High Pressure LiquidDrug CompoundingDrug PackagingDrug StabilityDrug StorageFeasibility StudiesTemperatureTime FactorsAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial Agentsamoxicillinclavulanic acid and antibiotic resistancecontinuous infusion

Identifiers

PMID34584403
PMCPMC8464313
OpenAlexW3191518597

What OpenQuestion holds

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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.