Title
Online monitoring of dissolution tests using dedicated potentiometric sensors in biorelevant media Online monitoring of dissolution tests using dedicated potentiometric sensors in biorelevant media
Author
Faculty/Department
Faculty of Sciences. Chemistry
Publication type
article
Publication
Stuttgart ,
Subject
Pharmacology. Therapy
Source (journal)
European journal of pharmaceutics and biopharmaceutics. - Stuttgart
Volume/pages
78(2011) :1 , p. 158-165
ISSN
0939-6411
ISI
000290056300019
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
Abstract
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 HPLCUV measurement. A modified method enabling the use of the ISE for very poorly soluble substances is also proposed. In terms of f2-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 HPLCUV 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 HPLCUV 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.
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