Department of Analytical Chemistry, University of Chemistry and Technology, Prague 6, Czech Republic; Zentiva, k.s., U Kabelovny 130, 102 37 Praha 10, Czech Republic.
Zentiva, k.s., U Kabelovny 130, 102 37 Praha 10, Czech Republic.
J Pharm Biomed Anal. 2021 Nov 30;206:114383. doi: 10.1016/j.jpba.2021.114383. Epub 2021 Sep 20.
The dubious online market in phosphodiesterase type 5 inhibitors is growing on a global scale. Counterfeit medical products can represent health issues for the user and cause medical mistrust. Within this work, genuine Cialis containing the active pharmaceutical ingredient (API) tadalafil, its generics available in the Czech Republic and the Cialis tablets from questionable online pharmacies were analysed. The methods of infra-red and Raman spectroscopy were used for the identification of the counterfeit tablets and for the verification of their API and excipients. All 9 tablets from online pharmacies were counterfeit with 2 of them even containing a different API (sildenafil, vardenafil). In addition, Raman mapping was used to determine the API and excipients' distribution and, in combination with multivariate data analysis, to separate similar tablets in clusters and to identify the outliers. Scanning electron microscopy of the samples revealed that the process of a wet granulation of micronized API was used during the formulation of the tablets. This comprehensive approach of analysis can be used for advanced exploration of the dubious samples of various medical products.
全球范围内，磷酸二酯酶 5 抑制剂的可疑在线市场正在不断扩大。假冒医疗产品可能会对使用者的健康造成影响，并导致对医疗产品的不信任。在这项工作中，对含有活性药物成分（API）他达拉非的正品希爱力、在捷克共和国可获得的仿制药以及来自可疑在线药店的希爱力片剂进行了分析。使用红外和拉曼光谱法对假冒片剂进行了鉴定，并对其 API 和赋形剂进行了验证。来自在线药店的 9 片片剂均为假冒品，其中 2 片甚至含有不同的 API（西地那非、伐地那非）。此外，还使用拉曼映射来确定 API 和赋形剂的分布，并结合多元数据分析，将相似的片剂聚类并识别异常值。对样品的扫描电子显微镜观察表明，在片剂的配方中使用了微粉化 API 的湿法制粒工艺。这种综合分析方法可用于对各种医疗产品的可疑样品进行深入探索。
