Ramos Paweł
Department of Biophysics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Jedności 8, 41-200 Sosnowiec, Poland.
Pharmaceuticals (Basel). 2022 Oct 14;15(10):1268. doi: 10.3390/ph15101268.
Confirmation of the composition of pharmaceutical products is an essential pharmaceutical issue. The purity and identity of active pharmaceutical ingredients (API) in the finished drug impact the effect of correct and safe pharmacotherapy. The currently frequently used advanced analytical methods are laborious and time-consuming. On the other hand, less advanced techniques such as UV-Vis spectrophotometry are less specific. In the presented study, thermogravimetry analysis (TGA)-supported by calculated differential thermal analysis (c-DTA)-was proposed to evaluate the composition of pharmaceutical preparations containing theophylline and aminophylline. Due to its advantages, the TGA method can be an alternative used for screening assessment of the composition of pharmaceutical preparations. The obtained results show that TGA supported by c-DTA is a suitable screening method for assessing the composition of pharmaceutical preparations containing theophylline and aminophylline. Both thermal techniques complement each other to obtain reliable results. In contrast to the pharmacopoeial UV-Vis method, TGA allows for unambiguous identification and distinction of one- and two-component pharmaceutical preparations. Moreover, thanks to TGA and c-DTA, it was possible to identify the excipient used in the formulation of a commercial drug and to detect considerable amounts of lactose in the experimentally prepared counterfeit formulation. The research herein indicates the multifaceted application and usefulness of TGA and c-DTA in pharmacology.
药品成分的确证是一个重要的药学问题。成品药物中活性药物成分（API）的纯度和特性会影响正确且安全的药物治疗效果。当前常用的先进分析方法既费力又耗时。另一方面，像紫外可见分光光度法这类不太先进的技术特异性较低。在本研究中，提出了热重分析（TGA）并辅以计算差示热分析（c-DTA）来评估含有茶碱和氨茶碱的药物制剂的成分。由于其优势，TGA方法可作为一种用于药物制剂成分筛选评估的替代方法。所得结果表明，c-DTA辅助的TGA是评估含有茶碱和氨茶碱的药物制剂成分的合适筛选方法。这两种热分析技术相互补充以获得可靠结果。与药典中的紫外可见方法不同，TGA能够明确鉴定和区分单组分和双组分药物制剂。此外，借助TGA和c-DTA，有可能鉴定出市售药物制剂中使用的辅料，并在实验制备的假冒制剂中检测到大量乳糖。本文的研究表明了TGA和c-DTA在药理学中的多方面应用及实用性。
