<p>Identification of substandard drug products using electronic tongue: cefdinir suspension as a pilot example</p>

Abstract

BackgroundElectronic tongue (ET) is a well-established technology that is used to detect the taste of a food or a medicinal product and to differentiate between different products based on their tastes. In addition, it can be used to monitor environmental parameters and biochemical and biological processes.PurposeThis study aims to assess any correlation between the results of pharmacopeial quality control (ie, assay, impurities, and dissolution, etc) and ET analysis for reconstituted cefdinir (CR) suspension over 10 days (ie, shelf-life).MethodsThe reconstituted CR suspension was tested for several quality attributes such as dissolution behavior, pH, assay, related substances, and microbial contamination. An HPLC analytical method was verified and then used for chemical analysis. The taste of CR reconstituted suspension was followed over 10 days and was then compared with the quality control results. Moreover, Pearson’s correlation test was used to find a correlation between chemical analysis results and ET results.ResultsPearson’s test of correlation showed a significant correlation (p-value <0.05) between the conventional chemical analysis results (% of CR, % of preservative, % of released CR, % of total impurities and % of total undefined impurities in the reconstituted suspension) with the change of their taste (ie, % pattern discrimination index). ET was able to correlate the results of stability of CR suspension with the change in the taste of the suspension during the shelf life of the reconstituted suspension.ConclusionThe obtained results may suggest the use of ET as a new tool for a rapid assessment of the general quality of a suspension. Moreover, such results would suggest the use of ET to identify fake or substandard products, especially those have been stored under inappropriate storage conditions.

Following drug degradation and consequent taste deterioration of an oral reconstituted paediatric suspension during dosing interval via electronic tongue

“…New sensor types able to evaluate active ingredient taste masking strategies are constantly being developed, one of these was the (Alpha-Astree, Alpha MOS, Toulouse, France) used here ( Podrażka, Bączyńska et al, 2018 ). In a previous study, the ET was used as a potential tool to identify the quality and the stability of the Cefdinir reconstituted suspensions and it was able to significantly correlate the change in the taste of the suspension to its chemical stability ( Abu-Khalaf, Zaid et al, 2019 ).…”

“…PCA is a well-known multivariate data analysis technique, and it shows the variations of the measurements. It was used in several studies related to ET ( Abu-Khalaf et al, 2019 , Al Ramahi et al, 2019 ).…”

“…ET has been used in many fields such as food industry, environmental, biotechnology, and most importantly oral pharmaceutical product evaluations Legin et al, 2004 , Abu-Khalaf and Iversen, 2007 ). Recently, we have shown that ET can be employed successfully to assess the stability of Cefdinir suspension after reconstitution ( Abu-Khalaf, Zaid et al, 2019 ). Eckert et al used ET as an alternative method in quality control of herbal lozenges.…”

Before reliable near infrared spectroscopic analysis - the critical sampling proviso. Part 2: Particular requirements for near infrared spectroscopy

“…personnel properly trained with respect to TOS. For specific examples see e.g., [28][29][30][31][32][33][34][35][36][37][38][39][40][41] which is a reference selection only, not exhaustive.…”