Evidence map›Paper›PMID 31023365›Full record

ArticleBMC pharmacology & toxicology2019

Quality of albendazole tablets legally circulating in the pharmaceutical market of Addis Ababa, Ethiopia: physicochemical evaluation.

Assegid Seifu, Elias Kebede, Belachew Bacha, Achenef Melaku, Tadese Setegn

Abstract readComparative Study
In one paragraph

Article in BMC pharmacology & toxicology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

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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

5 authors.

Assegid SeifuDepartment of Veterinary Pharmacy, College of Veterinary Medicine and Animal Sciences, University of Gondar, P. O. box= 196, Gondar, Ethiopia.
Elias KebedeDepartment of Veterinary Pharmacy, College of Veterinary Medicine and Animal Sciences, University of Gondar, P. O. box= 196, Gondar, Ethiopia.
Belachew BachaAnimal Products, Veterinary Drug and Feed Quality Assessment Centre, Veterinary Drug and Feed Control and Administration Authority, Addis Ababa, Ethiopia.
Achenef MelakuDepartment of Veterinary Pharmacy, College of Veterinary Medicine and Animal Sciences, University of Gondar, P. O. box= 196, Gondar, Ethiopia. tbeyene11@gmail.com.ORCID 0000-0002-7308-0182
Tadese SetegnAnimal Products, Veterinary Drug and Feed Quality Assessment Centre, Veterinary Drug and Feed Control and Administration Authority, Addis Ababa, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParasitic diseases are the main challenge of livestock production in the world. They are mainly controlled by the use of anthelmintic drugs. To be effective, the drugs should contain the appropriate amount of active pharmaceutical ingredient (API) and have the required physical characteristics. In this study, qualitative and quantitative assessments were performed to evaluate the quality of different brands of albendazole tablets legally circulating in pharmaceutical markets of Addis Ababa, Ethiopia.

methodsUltraviolet-Visible Spectroscopy (UVS), Fourier Transform Infrared Spectroscopy (FTIR) and High-Performance Liquid Chromatography (HPLC) were used for identification. Quantitative analysis was performed by HPLC. United States Pharmacopeia standard was used as a control to evaluate the identity and content of the API in the samples. A total of 10 batches of albendazole tablets from six different brands were collected and evaluated.

resultsAll brands of albendazole tablets, except one, had acceptable physical characteristics. There was gross contamination in one batch, weight variation in 4 (40%) batches, and absence of package insert in 2 (20%) batches. All three methods of evaluation (UVS, FTIR and HPLC) confirmed that all batches passed the identity test. Quantitative analysis showed that no batch had API above the acceptable limit. However, 30% of batches from three different brands contained lower amount of API per tablet than the acceptable limit.

conclusionsAll batches of albendazole circulating in the market in Addis Ababa did not fulfil either physical or chemical quality standards. The most important finding of this research was the presence of drugs with lower level of API than the acceptable limit. This can lead to treatment failure and favour the emergence of parasites that are resistant to drugs. Therefore, there should be a thorough evaluation of drugs before approval. The study also revealed the importance of occasional assessment of drugs circulating even in the legal market.

Indexed as

AlbendazoleAnthelminticsCitiesDrug LabelingEthiopiaQuality ControlTabletsAlbendazoleAnthelminticsTabletsAlbendazoleEthiopiaFTIRHPLCQuality assessmentUVS

Identifiers

PMID31023365
PMCPMC6485143

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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.