Abstract
The fight against counterfeit pharmaceuticals is a global issue of utmost importance, as failed medication results in millions of deaths every year. Particularly affected are antimalarial tablets. A very important issue is the identification of substandard tablets that do not contain the nominal amounts of the active pharmaceutical ingredient (API), and the differentiation between genuine products and products without any active ingredient or with a false active ingredient. This work presents a novel approach based on fiber-array based Raman hyperspectral imaging to qualify and quantify the antimalarial APIs lumefantrine and artemether directly and non-invasively in a tablet in a time-efficient way. The investigations were carried out with the antimalarial tablet Riamet® and self-made model tablets, which were used as examples of counterfeits and substandard. Partial least-squares regression modeling and density functional theory calculations were carried out for quantification of lumefantrine and artemether and for spectral band assignment. The most prominent differentiating vibrational signatures of the APIs were presented.
Highlights
Confidential reports to the World Health Organization (WHO) in the last few years from 20 countries relating to counterfeit drugs revealed that the three highest incidences of fake products were those without active pharmaceutical ingredients, followed by incorrect quantities of active ingredients and products with wrong ingredients [1]
We present a proof-of-principle study using fiber-array based Raman spectroscopy [34]
The vibrational band assignments of the active ingredients were performed based on density performedtheory based on density functional (DFT) calculations summarized in calculated
Summary
Confidential reports to the World Health Organization (WHO) in the last few years from 20 countries relating to counterfeit drugs revealed that the three highest incidences of fake products were those without active pharmaceutical ingredients (about 30%), followed by incorrect quantities of active ingredients and products with wrong ingredients (about 20% each) [1]. It is estimated that every 10th pharmaceutical product in low- and middle-income countries is substandard or falsified (SF). A report from 2014 [4] showed that among the over 9000 antimalarials sampled, nearly every third failed chemical or packaging quality tests, from which about 40% were classified as counterfeit or substandard and up to 20 wrong active ingredients were found in falsified antimalarials [4].
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