Rapid and Specific Drug Quality Testing Assay for Artemisinin and Its Derivatives Using a Luminescent Reaction and Novel Microfluidic Technology

Abstract

Globally, it is estimated that about 10–30% of pharmaceuticals are of poor quality. Poor-quality drugs lead to long-term drug resistance, create morbidity, and strain the financial structure of the health system. The current technologies for substandard drug detection either are too expensive for low-resource regions or only provide qualitative results. To address the current limitations with point-of-care technologies, we have developed an affordable and robust assay to quantify the amount of active pharmaceutical ingredients (APIs) to test product quality. Our novel assay consists of two parts: detection reagent (probe) and a microfluidic testing platform. As antimalarials are of high importance in the global fight against malaria and are often substandard, they are chosen as the model to validate our assay. As a proof-of-concept, we have tested the assay with artesunate pure and substandard samples (Arsuamoon tablets) from Africa and compared with the conventional 96-well plate with spectrophotometer to demonstrate the quantitative efficacy and performance of our system.

Essential medicines for universal health coverage

“…266 A suitcase-sized micro fl uidics device for rapid chemical analysis of medicines has been developed. 267 The US Food and Drug Administration has developed CD 3 , a handheld tool for the visual examination of packaging in comparison with reference images in the device. 268 Laboratory-based evaluations of single systems for a few medicines have been done, but diagnostic accuracy, ease of use, or cost-eff ectiveness, especially for co-formulated medicines, have not been assessed.…”

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

“…However, TLC is a mainly qualitative technique and less sensitive than HPLC, which nowadays represents the gold standard in pharmaceutical analysis . Although it requires a laboratory with sophisticated equipment, it has several advantages such as higher accuracy, precision, and resolution capability.…”

“…However, TLC is a mainly qualitative technique and less sensitive than HPLC, which nowadays represents the gold standard in pharmaceutical analysis. 30,34 Although it requires a laboratory with sophisticated equipment, it has several advantages such as higher accuracy, precision, and resolution capability. Using a slightly modified version of the method described in the monograph of The International Pharmacopoeia, HPLC-UV analysis permitted to confirm all the suspected cases, i.e., samples with only 1 or none of the 2 declared ingredients, and to discriminate substandard from good-quality medicines.…”

Substandard and falsified medicine screening technologies

“…PharmaChK is an instrument being developed by researchers at Boston University. Although originally intended to perform field dissolution, it is now being modified to provide quantitative information on the drug substance of interest (Desai 2014;Ho et al 2015). PharmaChk requires dissolving a sample in solution to measure its luminescence and is not yet commercially available.…”