title: New protocol for αAstree electronic tongue enabling full performance qualification according to ICH Q2.
abstract: Performance qualification (PQ) of taste sensing systems is mandatory for their use in pharmaceutical industry. According to ICH Q2 (R1) and a recent adaptation for taste sensing systems, non-specificity, log-linear relationships between the concentration of analytes and the sensor signal as well as a repeatability with relative standard deviation (RSD) values <4% were defined as basic requirements to pass a PQ. In the present work, the αAstree taste sensing system led to a successful PQ procedure by the use of recent sensor batches for pharmaceutical applications (sensor set #2) and a modified measurement protocol. Log-linear relationships between concentration and responses of each sensor were investigated for different bitter tasting active pharmaceutical ingredients (APIs). Using the new protocol, RSD values <2.1% were obtained in the repeatability study. Applying the visual evaluation approach, detection and quantitation limit could be determined for caffeine citrate with every sensor (LOD 0.05-0.5 mM, LOQ: 0.1-0.5 mM). In addition, the sensor set marketed for food applications (sensor set #5) was proven to show beneficial effects regarding the log-linear relationship between the concentration of quinine hydrochloride and the sensor signal. By the use of our proposed protocol, it is possible to implement the αAstree taste sensing system as a tool to assure quality control in the pharmaceutical industry.
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany. Miriam.pein@hhu.de
authors.forename: Miriam
authors.initials: M
authors.lastname: Pein
authors.forename: Carolin
authors.initials: C
authors.lastname: Eckert
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D015374:Biosensing Techniques / Q000295:instrumentation / Q000379:methods*; D002110:Caffeine / Q000737:chemistry; D002951:Citrates / Q000737:chemistry; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods*; D004581:Electronics / Q000295:instrumentation / Q000379:methods*; D011803:Quinine / Q000737:chemistry; D013649:Taste / Q000502:physiology*; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D014059:Tongue / Q000502:physiology*
chemical_list: D002951:Citrates; D002110:Caffeine; D011803:Quinine; C026189:caffeine citrate