Shah V P, Prasad V K, Freeman C, Skelly J P, Cabana B E
J Pharm Sci. 1983 Mar;72(3):309-10. doi: 10.1002/jps.2600720326.
A bioequivalence study was undertaken using an oral solution, a fast-dissolving capsule and a slow-dissolving phenytoin sodium capsule. The AUC, tmax and Cmax correlated with in vitro dissolution data. The results of the present studies substantiate the presence of two types of phenytoin sodium products on the market. On the basis of these studies, in vitro specifications for fast- and slow-dissolving phenytoin sodium capsules as well as the in vivo bioequivalence requirements for these two types of products are recommended.
采用口服溶液、速溶胶囊和缓释苯妥英钠胶囊进行了生物等效性研究。曲线下面积（AUC）、达峰时间（tmax）和峰浓度（Cmax）与体外溶出数据相关。本研究结果证实了市场上存在两种类型的苯妥英钠产品。基于这些研究，推荐了速溶和缓释苯妥英钠胶囊的体外规格以及这两种产品的体内生物等效性要求。
