Quality assessment of Diflucan® tablets distributed online: Diflucan® distributed online.

Abstract

Background: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan^®), an antifungal medicine used to treat deep mycoses, as "female Viagra^®."

Aim: The aim of this study was to investigate the authenticity and quality of Diflucan^® tablets distributed on the Internet.

Methods: We ordered Diflucan^® tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy.

Results: We obtained 11 samples of Diflucan^® tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan^® samples were confirmed as genuine and one sample was falsified. The genuine Diflucan^® samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan^® sample obtained in this study differed from the authentic Diflucan^® tablet. The falsified Diflucan^® sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan^® tablet obtained in this study differed from the authentic Diflucan^® tablet in near-infrared and Raman scattering spectroscopy.

Conclusion: We confirmed that one falsified Diflucan^® tablet was distributed online. Thus, continued measures against falsified medicines are required.