Veronin Michael A, Lee Eunah, Lewis E Neil
Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Kingsville, TX 78363, USA.
Ann Pharmacother. 2007 Jul;41(7):1111-5. doi: 10.1345/aph.1H680. Epub 2007 Jun 26.
Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US.
To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product.
Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis. Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets' internal structures.
The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets.
Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.
最近，美国国内对于从加拿大互联网药店进口药品存在诸多争议。美国食品药品监督管理局和美国药品制造商称，通过互联网从国际市场获取的药品存在因产品不合格而给消费者带来健康风险的问题。公众则认为来自加拿大的药品与来自美国的药品一样安全。
确定从加拿大非专利药生产商通过互联网购得的辛伐他汀片在混合均匀度（片剂质量的一个主要属性）方面是否与美国原创产品相当。
获取了来自4个加拿大互联网药店网站的非专利辛伐他汀片以及美国原创产品用于药学分析。使用近红外光谱成像技术对片剂样品进行分析，该技术旨在检测药品在生产过程中的配方缺陷。创建了数字图像，显示了片剂的内部结构。
测定了来自加拿大的片剂样品中活性药物成分的混合均匀度，并与美国原创产品的混合均匀度进行了比较。结果表明，美国原创片剂和加拿大非专利片剂在混合均匀度方面几乎没有显著差异。
本研究结果表明，美国原创产品和所测试的加拿大非专利药品具有相当的质量保证生产标准。这些发现具有临床、法律和经济意义，政策制定者应予以关注，以保护那些选择通过互联网购买加拿大生产药品的消费者。
