Evidence map›Paper›PMID 36862656›Full record

ArticlePloS one2023

Quality evaluation of the Azithromycin tablets commonly marketed in Adama, and Modjo towns, Oromia Regional State, Ethiopia.

Yesuneh Tefera Mekasha, Belachew Umeta Chali, Anbessa Bekele Feissa, Gemmechu Hasen Godena, Hassen Kebede Hassen, Sultan Suleman Wega

Abstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

6 authors.

Yesuneh Tefera MekashaPharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, Ethiopia.ORCID 0000-0003-2225-7088
Belachew Umeta ChaliPharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia.
Anbessa Bekele FeissaPharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia.
Gemmechu Hasen GodenaPharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia.ORCID 0000-0002-1693-0240
Hassen Kebede HassenVeterinary Drug and Feed Control and Administration Authority, Addis Ababa, Ethiopia.
Sultan Suleman WegaPharmaceutical Sciences, School of Pharmacy, Institute of Health, Jimma University, Jimma, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAzithromycin is a therapeutically" relevant macrolide antibiotic registered on the Essential Medicines List of the World Health Organization. The fact that medicine is selected as an essential drug doesn't mean that it is of good quality. Hence, a continuous quality evaluation of the drug should be mandated to verify that the right medication is available on the market.

objectiveTo evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia.

methodsAll six brands were subjected to in-vitro quality control tests, which were carried out according to procedures described in the manufacturer's method, the United States Pharmacopeia, and the WHO inspection tool. All quality control parameters were compared by one-way ANOVA. Statistically, significant difference was considered when P<0.05. The in-vitro dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches.

resultsAll of the evaluated brands agreed with WHO visual inspection criteria. All of the tablets achieved the thickness, and diameter test requirements of the manufacturer's specification (±5%). All brands passed the hardness, friability, weight variation, disintegration, identity, and assay tests as stipulated by USP. The dissolution rate was more than 80% in 30 minutes, which was within the USP specification. The model-independent parameters have confirmed that only two brands (2/6) were deemed better brands for interchangeability. Weibull and Korsemeyer's Peppas model were the best release models.

conclusionAll of the evaluated brands passed the quality specification. The model dependent approaches revealed that drug release data fit well to the Weibull, and Korsemeyer's Peppas release models. However, the model-independent parameters have confirmed that only two brands were deemed better brands (2/6) for interchangeability. Due to the dynamic nature of low-quality medications, the Ethiopian Food, and Drug Authority should keep an eye on marketed products to guarantee their quality, especially for drugs like azithromycin for which non-bioequivalence data from the study has revealed a clinical concern.

Indexed as

AzithromycinDrugs, EssentialAnti-Bacterial AgentsCitiesEthiopiaMacrolidesAnti-Bacterial AgentsAzithromycinDrugs, EssentialMacrolides

Identifiers

PMID36862656
PMCPMC9980786

What OpenQuestion holds

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LicenceCC BY
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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.