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.
Highlights
The World Health Organization (WHO) estimates that about 10–30% of pharmaceuticals in the world are of poor quality, counterfeit, falsified or broadly speaking, substandard.[1]
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
There are three broad classes or methods used for the detection of substandard pharmaceuticals: high-performance liquid chromatography (HPLC), handheld Raman spectroscopy (RS) or near-infrared spectroscopy instruments, and thin-layer chromatography (TLC)-based systems
Summary
The World Health Organization (WHO) estimates that about 10–30% of pharmaceuticals in the world are of poor quality, counterfeit, falsified or broadly speaking, substandard.[1]. There are three broad classes or methods used for the detection of substandard pharmaceuticals: high-performance liquid chromatography (HPLC), handheld Raman spectroscopy (RS) or near-infrared spectroscopy instruments, and thin-layer chromatography (TLC)-based systems. HPLC is the gold standard method used for the analysis of different active pharmaceutical ingredients (APIs) and impurities within the drug tablets.[3] HPLC is a powerful tool for quantitative analysis of pharmaceuticals and its impurities. That makes a complete system’s cost too expensive (often upwards of $100,000) for low-resources settings and field testing.[4] appropriate maintenance and storage for the advanced devices are required. Trained personnel are required for maintenance and operation of HPLC
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