Investigating the Presence of Falsified and Poor-Quality Fixed-Dose Combination Artemether-Lumefantrine Pharmaceutical Dosage Forms in Kumasi, Ghana

Artemether-lumefantrine (AL) is a highly effective and commonly used Artemisinin-based Combination Therapy (ACT) for treating uncomplicated malaria caused by Plasmodium falciparum, including drug-resistant strains. However, ineffective regulatory systems in resource-limited settings can lead to the...

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Bibliographic Details
Published in:Advances in pharmacological and pharmaceutical sciences 2024-03, Vol.2024, p.2650540-11
Main Authors: Nyarko, Simon, Ofori-Kwakye, Kwabena, Johnson, Raphael, Kuntworbe, Noble, Yar, Denis Dekugmen
Format: Article
Language:English
Subjects:
Antiparasitic agents
Counterfeiting
Disease
Dosage and administration
Drug counterfeiting
Drug dosages
Drug resistance
Drug stores
Drug therapy, Combination
Drugstores
Investigations
Low income groups
Malaria
Marketing
Mortality
Patients
Pharmaceutical industry
Pharmacovigilance
Pharmacy
Plasmodium falciparum
Public health
Supply chains
Surveillance equipment
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Summary:Artemether-lumefantrine (AL) is a highly effective and commonly used Artemisinin-based Combination Therapy (ACT) for treating uncomplicated malaria caused by Plasmodium falciparum, including drug-resistant strains. However, ineffective regulatory systems in resource-limited settings can lead to the infiltration of poor-quality and counterfeit antimalarial medicines into the pharmaceutical supply chain, causing treatment failures, prolonged illness, and disease progression. The objective of the study was to assess the quality of selected brands of fixed-dose combination (FDC) AL tablets and suspensions marketed in Kumasi, Ghana. A total of fourteen brands of FDC AL medicines, comprising eight tablets and six suspensions were purchased from various retail pharmacy outlets in Kumasi, Ghana. All samples were subjected to thorough visual inspection as a quick means of checking quality through meticulous observation of the packaging or dosage form. The quality parameters of the tablets were determined using uniformity of weight, hardness, friability, and disintegration tests. Suspensions were assessed based on pH and compared with the British Pharmacopeia (BP) standard. The samples were then analyzed for drug content (assay) using reverse-phase high-performance liquid chromatography (RP-HPLC). All the tablet samples conformed to BP specification limits for uniformity of weight (deviation of less than ± 5%), hardness (4.0–10 kg/mm2), friability (
ISSN:2633-4682
2633-4690
2633-4690
DOI:10.1155/2024/2650540