F. Hoffmann-La Roche Ltd., Bldg 250 Room 3.504.01, Wurmisweg, 4303 Kaiseraugst, Switzerland.
Talanta. 2019 Jun 1;198:487-500. doi: 10.1016/j.talanta.2019.01.121. Epub 2019 Feb 11.
Packaging analysis is an important step in the authentication of medicines. All types of medicines are nowadays targeted by the counterfeiters, and among them, vials of injectable medicines. This type of pharmaceutical product is often a combination of fake parts and genuine but stolen, expired, reused and/or manipulated parts. For this reason, while the visual comparison with references is necessary to identify the packaging, it is sometimes difficult to see visual differences for each of the parts that compose a pharmaceutical vial. Several analytical tools were successfully tested to support the investigation of 31 counterfeited vials. Moreover eight counterfeited vials originating from different seizures could be linked based on the chemical or elemental composition of the different vial parts. Raman spectroscopy and microscopy, X-ray fluorescence spectroscopy, Infrared spectroscopy and optical microscopy proved especially efficient to support the visual comparison for the authentication of counterfeited flip off caps, aluminium crimping caps, stoppers, glass vials and vial labels and to detect links between the counterfeits at each of these levels. This last information can be especially useful for on-going investigations. The understanding of how the packaging was faked and manipulated could also be provided, which is also very valuable for prevention purposes, for example for the design of a more robust - and therefore more difficult to counterfeit - packaging.
包装分析是药品认证的重要步骤。如今，所有类型的药品都成为了造假者的目标，其中包括注射用药品的小瓶。这种药品通常是由假冒部件和真实但被盗、过期、重复使用和/或被篡改的部件组成。因此，虽然通过视觉与参考品进行对比是识别包装的必要手段，但有时对于构成药瓶的每个部件，很难看出视觉上的差异。已经成功测试了几种分析工具来支持对 31 个假冒小瓶的调查。此外，根据不同小瓶部件的化学或元素组成，可以将 8 个来自不同扣押的假冒小瓶联系起来。拉曼光谱和显微镜、X 射线荧光光谱、红外光谱和光学显微镜特别有效地支持对假冒的翻盖盖、铝压接盖、瓶塞、玻璃小瓶和小瓶标签进行视觉对比，并在这些层面上检测假冒产品之间的联系。这些信息对于正在进行的调查特别有用。了解包装是如何被伪造和篡改的，也可以为预防目的提供帮助，例如设计更坚固的包装（因此更难伪造）。
