Quality assessment of Diflucan ? tablets distributed online: Diflucan ? distributed online

摘要

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.