Quality assessment of Diflucan<sup>®</sup> tablets distributed online: Diflucan<sup>®</sup> distributed online
T. Sanada, Myu Ohnishi, Naoko Yoshida, Kazuko Kimura, Hirohito Tsuboi
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.