Julianto T, Yuen K H, Noor A M
Department of Pharmaceutics, School of Pharmaceutical Sciences, University of Science Malaysia, Penang.
Int J Pharm. 2000 Apr 25;200(1):53-7. doi: 10.1016/s0378-5173(00)00337-9.
A single dose study was conducted to evaluate the bioavailability of a novel self-emulsifying vitamin E preparation, in comparison with that of a commercial product, Natopherol, available as soft gelatin capsules under fasted condition. The self-emulsifying preparation achieved a faster rate and higher extent of absorption. A statistically significant difference was observed between the values of the two preparations in the parameters AUC, Cmax and Tmax. Moreover, the 90% confidence interval of the logarithmic transformed AUC values of the self-emulsifying preparation over those of the soft gelatin capsule product was found to be between 2.1 and 4.1, suggesting an increase in bioavailability of between 210 and 410%. As for Cmax, the 90% confidence interval was between 2.1 and 3.0. However, no statistically significant difference was observed between the t(1/2) values estimated from the plasma concentration versus time data of the two preparations. The values are also comparable to those reported in the literature.
开展了一项单剂量研究，以评估一种新型自乳化维生素E制剂与市售产品Natopherol（以软胶囊形式提供）在禁食条件下的生物利用度。自乳化制剂实现了更快的吸收速率和更高的吸收程度。在AUC、Cmax和Tmax参数方面，观察到两种制剂的值存在统计学显著差异。此外，发现自乳化制剂与软胶囊产品的对数转换AUC值的90%置信区间在2.1至4.1之间，表明生物利用度提高了210%至410%。至于Cmax，90%置信区间在2.1至3.0之间。然而，根据两种制剂的血浆浓度与时间数据估计的t(1/2)值之间未观察到统计学显著差异。这些值也与文献报道的值相当。
