Abstract

Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory study, Raman spectroscopy was performed to evaluate the applicability of the ultra-compact Raman scattering spectrometer (C13560). Principal component analysis (PCA) was also performed on the Raman spectra. This study analyzed tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) tablets. We tested the standard product and products purchased from the internet (genuine or falsified). For Cialis and Levitra, all falsified tablets were identified by the Raman spectra and PCA score plot. For Viagra, the Raman spectra of some falsified tablets were almost comparable to the standard tablet. The PCA score plots of falsified tablets were dispersed, and some plots of falsified tablets were close to the standard tablet. In conclusion, C13560 was useful for the discrimination of falsified Cialis and Levitra tablets, whereas some falsified Viagra tablets had Raman spectra similar to that of the standard tablet. The development of detection methods that can be introduced in various settings may help prevent the spread of falsified products.

Highlights

  • Substandard and falsified medicines have been increasing worldwide and have become a global threat

  • “Falsified” medicines intentionally misrepresent the details of products, “substandard” medicines are authorized medical products that do not meet quality standards, and “unregistered/unlicensed” medicines have not been approved for sale under the relevant regulations and legislation, as per World Health Organization (WHO)

  • We examined the usefulness of the ultra-compact Raman spectrometer as a non-destructive detection method

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Summary

Introduction

Substandard and falsified medicines have been increasing worldwide and have become a global threat. “Falsified” medicines intentionally misrepresent the details of products, “substandard” medicines are authorized medical products that do not meet quality standards, and “unregistered/unlicensed” medicines have not been approved for sale under the relevant regulations and legislation, as per World Health Organization (WHO). Substandard and falsified medicines put people’s health at risk [2]. The exact number of substandard and falsified medical products worldwide cannot be determined. According to an estimate published by the Center for Medicine in the Public Interest in the United States of America, substandard and falsified medicine sales exceeded 75 billion US dollars in 2010 [3].

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