Abstract
The availability of falsified antimalarial drugs can be reduced with effective drug regulatory agencies and proper enforcement. Fundamental to these agencies taking action, rapid identification must be made as soon as they appear in the market place. Since falsified antimalarials occur mostly in developing countries, performing drug analysis presents itself with unique challenges. A fundamental factor in choosing a useful technique is affordability and simplicity. Therefore, we suggest a three-tiered drug evaluation strategy for identifying a falsified drug in resource-poor areas. Tier I is a simple comparison of a tablet's weight and dimensions with official specifications. Tier II uses inexpensive photometric devices (laser and fluorescence) to evaluate a tablet. Suspicious samples from Tier I and II assessments are then subjected to a colorimetric assay for active ingredients identification and quantification. In this article, we evaluate a novel colorimetric assay for the simultaneous assessment of both lumefantrine and artemether in co-formulated Coartem™ tablets, and integrate the method with two novel, low-cost, fluorescence and laser photometric devices. Image analysis software is used for the assessments. Although artemether–lumefantrine is used as an example, the strategy may be adapted to other medicines.
Highlights
Low-income countries bear the highest proportion of deaths caused by human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), tuberculosis, and malaria
Since no colors were apparent for either LF or AM for CF #1, CF #2, CF #4, and CF #5, these samples were considered to be falsified products based on the absence of both active ingredients via the colorimetric assay
high-performance liquid chromatography (HPLC) analysis revealed this suspected that sample CF #6 may have been an expired/ degraded product, which may have been repackaged to resemble a legitimate product with an altered expiration date
Summary
Low-income countries bear the highest proportion of deaths caused by human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), tuberculosis, and malaria. The artemisinins are the most rapidly acting of all antimalarial drugs,[2] potential resistance has led to the abandonment of oral artemisinin monotherapy This class of antimalarial is combined with a partner drug, such as lumefantrine, amodiaquine, piperaquine, or mefloquine, possessing a longer half-life. This formulation, termed artemisinin combination therapy (ACT) is recommended by the World Health Organization (WHO) as first-line treatment in most malariaendemic countries.[3] An ACT being very widely purchased and distributed by international and national organizations globally combines lumefantrine (long half-life drug) with artemether (artemisinin derivative) into a fixed-dose tablet (AMLF). As a result of the expanding market in Africa, falsified (counterfeit) AMLF (Coartem) has already been reported in many west and central African countries.[5,6]
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