Chemical analysis of counterfeit hepatitis C drug found in Japan.

Chemical analysis of counterfeit hepatitis C drug found in Japan. Yakugaku Zasshi. 2017 Jul 19;: Authors: Uchiyama N, Kamakura H, Masada S, Tsujimoto T, Hosoe J, Tokumoto H, Maruyama T, Goda Y, Hakamatsuka T Abstract <bibitem lang="en">  In January 2017, counterfeits of the hepatitis C drug 'HARVONI(®) Combination Tablets' (HARVONI(®)) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI(®) (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVARDI(®) Tablets 400 mg (SOVARDI(®)), was detected. In sample 4A, sofosbuvir and ledipasvir, the active components of HARVONI(®), were found. A direct comparison of the four samples and genuine products showed that three samples (2A, 3, 4B) are apparently SOVARDI(®) and that sample 2A is HARVONI(®). In samples 1 and 5, several vitamins but none of the active compounds usually found in HARVONI(®) (i.e., sofosbuvir and ledipasvir) were detected. Our additional investigation indicates that these two samples are likely to be a commercial vitamin supplement distributed in Japan. Sample 2B, looked ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - Category: Drugs & Pharmacology Authors: Tags: Yakugaku Zasshi Source Type: research