Shu Zhu1, Naoko Yoshida2, Hirohito Tsuboi3, Ryo Matsushita3, Kazuko Kimura1. 1. Graduate School of Medical Sciences, Medi-Quality Security Institute, Kanazawa University, Kakuma-machi, Kanazawa, 920-1192, Japan. 2. AI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa, 920-1192, Japan. naoko@p.kanazawa-u.ac.jp. 3. Clinical Pharmacy and Healthcare Sciences, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-machi, Kanazawa, 920-1192, Japan.
Abstract
BACKGROUND: Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. METHODS: In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC-PDA. RESULTS: Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. CONCLUSIONS: Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.
BACKGROUND: Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. METHODS: In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC-PDA. RESULTS: Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. CONCLUSIONS: Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.
Entities:
Keywords:
Internet; Metformin; Personal import; Poor-quality medicine; Quality
Authors: N H Cho; J E Shaw; S Karuranga; Y Huang; J D da Rocha Fernandes; A W Ohlrogge; B Malanda Journal: Diabetes Res Clin Pract Date: 2018-02-26 Impact factor: 5.602
Authors: Kah Seng Lee; Siew Mei Yee; Syed Tabish Razi Zaidi; Rahul P Patel; Quan Yang; Yaser Mohammed Al-Worafi; Long Chiau Ming Journal: Front Pharmacol Date: 2017-05-16 Impact factor: 5.810