Evidence map›Paper›PMID 33493211›Full record

ArticlePLoS neglected tropical diseases2021

Quality and composition of Albendazole, Mebendazole and Praziquantel available in Burkina Faso, Côte d'Ivoire, Ghana and Tanzania.

Moritz Seitzer, Sylvia Klapper, Humphrey D Mazigo, Ulrike Holzgrabe, Andreas Mueller

Abstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Article
  3. Article
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  5. Article
  6. Article
  7. Article
  8. Review
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.

Moritz SeitzerMedical Mission Institute, Würzburg, Bavaria, Germany.ORCID 0000-0002-5016-0198
Sylvia KlapperInstitute of Pharmacy and Food Chemistry, Julius-Maximilians-University of Würzburg, Würzburg, Germany.ORCID 0000-0001-5700-2902
Humphrey D MazigoDepartment of Medical Parasitology and Entomology, Catholic University of Health and Allied Sciences, Mwanza, Lake Zone, United Republic of Tanzania.
Ulrike HolzgrabeInstitute of Pharmacy and Food Chemistry, Julius-Maximilians-University of Würzburg, Würzburg, Germany.ORCID 0000-0002-0364-7278
Andreas MuellerMedical Mission Institute, Würzburg, Bavaria, Germany.ORCID 0000-0002-5619-1550

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEven though the international combat against Neglected Tropical Diseases such as schistosomiasis or soil-transmitted helminthiases depends on reliable therapeutics, anthelminthic pharmacovigilance has been neglected on many national African drug markets. Therefore, quality and composition of Albendazole, Mebendazole and Praziquantel locally collected in Burkina Faso, Côte d'Ivoire, Ghana and Tanzania were analysed.

methodsSamples of 88 different batches were obtained from randomly selected facilities. Sampling took place in Northwest Tanzania, Western Burkina Faso, Southeast Côte d'Ivoire and Southwest Ghana. Visual examination of both packaging and samples was performed according to the WHO 'Be Aware' tool. Products were then screened with the GPHF Minilab, consisting of tests of mass uniformity, disintegration times and thin-layer chromatography (TLC). Confirmatory tests were performed according to international pharmacopoeiae, applying assays for dissolution profiles and high-performance liquid chromatography (HPLC).

findingsDespite minor irregularities, appearance of the products did not hint at falsified medicines. However, 19.6% of the brands collected in Ghana and Tanzania were not officially licensed for sale. Mass uniformity was confirmed in 53 out of 58 brands of tablets. 41 out of 56 products passed disintegration times; 10 out of the 15 failing products did not disintegrate at all. Evaluating TLC results, only 4 out of 83 batches narrowly missed specification limits, 18 batches slightly exceeded them. Not more than 46.3% (31 / 67) of the tablets assayed passed the respective pharmaceutical criteria for dissolution. HPLC findings confirmed TLC results despite shifted specification limits: 10 out of 83 tested batches contained less than 90%, none exceeded 110%.

conclusionIn the four study countries, no falsified anthelminthic medicine was encountered. The active pharmaceutical ingredient was not found to either exceed or fall below specification limits. Galenic characteristics however, especially dissolution profiles, revealed great deficits.

Indexed as

AlbendazoleAnthelminticsBurkina FasoCote d'IvoireGhanaHelminthiasisHumansMebendazolePraziquantelSchistosomiasisTabletsTanzaniaAlbendazoleAnthelminticsMebendazolePraziquantelTablets

Identifiers

PMID33493211
PMCPMC7861518

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.