Kiguchiya Akihito, Teraoka Reiko, Sakane Toshiyasu
Technology Research & Development Division, Sumitomo Dainippon Pharma Co., Ltd.
Laboratory of Pharmaceutical Technology, Kobe Pharmaceutical University.
Chem Pharm Bull (Tokyo). 2018;66(9):892-895. doi: 10.1248/cpb.c18-00389.
Evaluating the stability of drugs over ranges of various environmental conditions is necessary to ensure the quality of the drug throughout the shelf life. In this study, we used indomethacin, which is well known as a photosensitive drug, and evaluated the photostability of prepared crystals. HPLC analysis revealed that all the indomethacin crystals were degraded by light exposure. However, the indomethacin crystals involving solvates had different degrees of photodegradation and different solid-state UV/Vis spectra. The value of the absorption integral in the UVA range related closely to the photodegradation of indomethacin crystals involving solvates. Therefore, it is easy to compare the photosensitivity among the crystals without actual analytical data, by use of a suitable analytical method and using light exposure samples. Moreover, it is possible to predict the value of photodegradation ratio from the solid-state UV/Vis spectra of indomethacin crystals. Therefore, this method may provide key information for selecting the most appropriate crystal form of photosensitive drugs.
评估药物在各种环境条件范围内的稳定性对于确保药物在整个保质期内的质量是必要的。在本研究中，我们使用了众所周知的光敏药物吲哚美辛，并评估了制备晶体的光稳定性。高效液相色谱分析表明，所有吲哚美辛晶体均因光照而降解。然而，含有溶剂化物的吲哚美辛晶体具有不同程度的光降解和不同的固态紫外/可见光谱。UVA范围内的吸收积分值与含有溶剂化物的吲哚美辛晶体的光降解密切相关。因此，通过使用合适的分析方法和光照样品，无需实际分析数据就很容易比较晶体之间的光敏性。此外，从吲哚美辛晶体的固态紫外/可见光谱可以预测光降解率的值。因此，该方法可能为选择光敏药物最合适的晶型提供关键信息。
