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Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

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...

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Autores principales: Zhu, Shu, Yoshida, Naoko, Tsuboi, Hirohito, Matsushita, Ryo, Kimura, Kazuko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238764/
https://www.ncbi.nlm.nih.gov/pubmed/33595786
http://dx.doi.org/10.1007/s43441-021-00262-3
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author Zhu, Shu
Yoshida, Naoko
Tsuboi, Hirohito
Matsushita, Ryo
Kimura, Kazuko
author_facet Zhu, Shu
Yoshida, Naoko
Tsuboi, Hirohito
Matsushita, Ryo
Kimura, Kazuko
author_sort Zhu, Shu
collection PubMed
description 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.
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spelling pubmed-82387642021-07-13 Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites Zhu, Shu Yoshida, Naoko Tsuboi, Hirohito Matsushita, Ryo Kimura, Kazuko Ther Innov Regul Sci Original Research 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. Springer International Publishing 2021-02-17 2021 /pmc/articles/PMC8238764/ /pubmed/33595786 http://dx.doi.org/10.1007/s43441-021-00262-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Research
Zhu, Shu
Yoshida, Naoko
Tsuboi, Hirohito
Matsushita, Ryo
Kimura, Kazuko
Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title_full Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title_fullStr Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title_full_unstemmed Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title_short Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites
title_sort quality and authenticity of metformin tablets circulating on japanese websites
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238764/
https://www.ncbi.nlm.nih.gov/pubmed/33595786
http://dx.doi.org/10.1007/s43441-021-00262-3
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