Analytical Development, Aptuit Laurus Pvt. Ltd., ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, 500 078, India.
AAPS PharmSciTech. 2012 Jun;13(2):548-55. doi: 10.1208/s12249-012-9774-7. Epub 2012 Apr 3.
Vapor-induced transformations of docetaxel anhydrous (form D(A)) under ambient conditions have been studied using methanol, ethanol, and water as the solvent media. The online vapor-induced transformations were monitored by powder X-ray diffractometry. New solid forms (solvates/hydrates/anhydrous) of docetaxel anhydrous were obtained in stoichiometric ratios which were characterized completely using powder X-ray diffraction, differential scanning calorimeter, thermogravimetric analysis, and spectroscopic ((13)C solid-state nuclear magnetic spectroscopy, solution (1)H NMR, and Fourier transform infrared) techniques. The new forms namely methanol solvate (D(M)), ethanol solvate (D(E)), monohydrate (D(MH)), trihydrate (D(TH)), and anhydrous (D(AN-I) and D(AN-II)) were identified through structural analysis.
在环境条件下,使用甲醇、乙醇和水作为溶剂介质,研究了多西他赛无水物(形式 D(A))的气相诱导转变。通过粉末 X 射线衍射法在线监测气相诱导转变。以化学计量比获得了多西他赛无水物的新固体形式(溶剂化物/水合物/无水物),并通过粉末 X 射线衍射、差示扫描量热法、热重分析和光谱((13)C 固态核磁共振波谱、溶液(1)H NMR 和傅里叶变换红外)技术对其进行了全面表征。通过结构分析,确定了新的形式,即甲醇溶剂化物(D(M))、乙醇溶剂化物(D(E))、一水合物(D(MH))、三水合物(D(TH))以及无水物(D(AN-I)和 D(AN-II))。