title: Online monitoring of dissolution tests using dedicated potentiometric sensors in biorelevant media.
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 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.
authors.affiliation: Institute for Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Juenemann
authors.forename: Hugo
authors.initials: H
authors.lastname: Bohets
authors.forename: Mahir
authors.initials: M
authors.lastname: Ozdemir
authors.forename: Roy
authors.initials: R
authors.lastname: de Maesschalck
authors.forename: Koen
authors.initials: K
authors.lastname: Vanhoutte
authors.forename: Karl
authors.initials: K
authors.lastname: Peeters
authors.forename: Luc
authors.initials: L
authors.lastname: Nagels
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Dressman
mesh_terms: D001826:Body Fluids; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D066298:In Vitro Techniques; D017736:Ion-Selective Electrodes; D011199:Potentiometry; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet