Institute for Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.
Eur J Pharm Biopharm. 2011 May;78(1):158-65. doi: 10.1016/j.ejpb.2010.12.014. Epub 2010 Dec 17.
The performance of the Ion-Selective Electrode (ISE) for in vitro dissolution testing using biorelevant media was evaluated in this study. In vitro dissolution was carried out using USP apparatus 2 (paddle method) with classical and with updated biorelevant media to simulate the pre- and postprandial states. The ISE was used as an analytical stand-alone system and in combination with a single-point HPLC-UV measurement. A modified method enabling the use of the ISE for very poorly soluble substances is also proposed. In terms of f(2)-factor, the results acquired using the ISE for the drug diphenhydramine-HCl were found to be very similar to the results obtained by manual sampling followed by HPLC-UV analysis. In Fed State Simulated Gastric Fluid (FeSSGF), a medium containing 50% milk, the ISE is more practical since the need to separate proteins from the analyte prior to HPLC-UV analysis is eliminated. Further work will be needed to establish ISE methodology for Fed State Simulated Intestinal Fluid (FeSSIF) media. In summary, the ISE has promise as an analytical tool for research and development applications.
本研究评估了用于使用生物相关介质进行体外溶解测试的离子选择性电极 (ISE) 的性能。体外溶解使用 USP 仪器 2（桨法）进行，使用经典和更新的生物相关介质模拟空腹和餐后状态。ISE 被用作独立的分析系统，并与单点 HPLC-UV 测量相结合。还提出了一种改进的方法，使 ISE 能够用于非常难溶的物质。就 f(2) 因子而言，使用 ISE 获得的药物苯海拉明盐酸盐的结果与手动采样后进行 HPLC-UV 分析的结果非常相似。在含有 50%牛奶的 Fed State Simulated Gastric Fluid (FeSSGF) 介质中，ISE 更实用，因为在进行 HPLC-UV 分析之前无需将蛋白质与分析物分离。需要进一步的工作来建立用于 Fed State Simulated Intestinal Fluid (FeSSIF) 介质的 ISE 方法。总之，ISE 有望成为研究和开发应用的分析工具。
