Wesolowski Marek, Rojek Barbara, Piotrowska Joanna
Medical University of Gdansk, Department of Analytical Chemistry, Gdansk, Poland.
J AOAC Int. 2012 May-Jun;95(3):691-8. doi: 10.5740/jaoacint.sge_wesolowski.
Studies are constantly being conducted on the elaboration of efficient methods to confirm the compatibility of active pharmaceutical ingredients (APIs) and excipients, since medicinal products, apart from their APIs, also contain numerous excipients that not only have important functions in pharmaceutical preparations but can also initiate or participate in interactions with drug substances, which eventually lead to a decline in drug quality. With this in mind, research was undertaken to evaluate two of the most often applied pattern recognition methods, hierarchical cluster analysis (HCA) and principal component analysis (PCA), as supporting techniques in the identification of potential physicochemical interactions that may occur during the preformulation of solid dosage forms. The investigation performed with the use of baclofen and selected excipients has shown that with thermogravimetric analysis, HCA and PCA fulfill their role as supporting techniques in the interpretation of the data obtained. Based on these methods, it is possible to detect incompatibilities between baclofen and excipients, and the data obtained concur strongly with the results of differential scanning calorimetry and IR spectrometry analyses.
人们一直在进行研究，以制定有效的方法来确认活性药物成分（API）与辅料的相容性，因为药品除了其API外，还含有大量辅料，这些辅料不仅在药物制剂中具有重要作用，还可能引发或参与与药物物质的相互作用，最终导致药物质量下降。考虑到这一点，开展了研究以评估两种最常用的模式识别方法，即层次聚类分析（HCA）和主成分分析（PCA），作为识别固体剂型处方前可能发生的潜在物理化学相互作用的辅助技术。使用巴氯芬和选定辅料进行的研究表明，通过热重分析，HCA和PCA在解释所获得的数据方面发挥了辅助技术的作用。基于这些方法，可以检测巴氯芬与辅料之间的不相容性，并且所获得的数据与差示扫描量热法和红外光谱分析的结果高度一致。
