Stephens D, Li L C, Pec E, Robinson D
Hospital Products Division, Abbott Laboratories, Abbott Park, IL 60064-3500, USA.
Drug Dev Ind Pharm. 1999 Aug;25(8):961-5. doi: 10.1081/ddc-100102258.
19-Nor-1 alpha, 25-dihydroxyvitamin D2, an analog of vitamin D2, is a nonpolar compound with limited solubility in water. An injectable solution was formulated using a cosolvent system consisting of water, ethanol, and propylene glycol. A statistical response surface approach was used to evaluate the effect of these three solvents on the solubility of the drug (25 degrees C) in the ternary cosolvent system. The data generated from five selected formulations were used to develop a multiple linear regression model that quantitatively defines the solubility of the drug as a function of the cosolvent composition. Close agreement was found between the experimental data and data calculated using the model. The capability of this model to predict drug solubility in cosolvent systems with various combinations of the three solvents was also verified.
19-去甲-1α,25-二羟基维生素D2是维生素D2的类似物，是一种在水中溶解度有限的非极性化合物。使用由水、乙醇和丙二醇组成的助溶剂体系配制了一种注射溶液。采用统计响应面方法评估这三种溶剂对药物在三元助溶剂体系中（25℃）溶解度的影响。从五个选定配方生成的数据用于建立多元线性回归模型，该模型定量地将药物溶解度定义为助溶剂组成的函数。实验数据与使用该模型计算的数据之间发现了密切的一致性。该模型预测药物在三种溶剂不同组合的助溶剂体系中溶解度的能力也得到了验证。
