Methods for Estimating the Detection and Quantification Limits of Key Substances in Beer Maturation with Electronic Noses.

To evaluate the suitability of an analytical instrument, essential figures of merit such as the limit of detection (LOD) and the limit of quantification (LOQ) can be employed. However, as the definitions k nown in the literature are mostly applicable to one signal per sample, estimating the LOD for substances with instruments yielding multidimensional results like electronic noses (eNoses) is still challenging. In this paper, we will compare and present different approaches to estimate the LOD for eNoses by employing commonly used multivariate data analysis and regression techniques, including principal component analysis (PCA), principal component regression (PCR), as well as partial least squares regression (PLSR).

Critical View on the Qualification of Electronic Tongues Regarding Their Performance in the Development of Peroral Drug Formulations with Bitter Ingredients.

In this review, we aim to highlight the advantages, challenges, and limitations of electronic tongues (e-tongues) in pharmaceutical drug development. The authors, therefore, critically evaluated the performance of e-tongues regarding their qualification to assess peroral formulations containing bitter active pharmaceutical ingredients. A literature search using the keywords 'electronic', 'tongue', 'bitter', and 'drug' in a Web of Science search was therefore initially conducted.

A Machine Learning Approach to Qualitatively Evaluate Different Granulation Phases by Acoustic Emissions.

Wet granulation is a frequent process in the pharmaceutical industry. As a starting point for numerous dosage forms, the quality of the granulation not only affects subsequent production steps but also impacts the quality of the final product. It is thus crucial and economical to monitor this operation thoroughly.

Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation.

Pellet production is a multi-step manufacturing process comprising granulation, extrusion and spheronisation. The first step represents a critical control point, since the quality of the granule mass highly influences subsequent process steps and, consequently, the quality of final pellets. The most important parameter of wet granulation is the liquid requirement, which can often only be quantitatively evaluated after further process steps.

Implementation of real-time and in-line feedback control for a fluid bed granulation process.

The application of process analytical technologies (PAT) to monitor critical quality attributes (CQAs) provides an important approach to enhance process understanding and improve the reliability of pharmaceutical production processes. The present study focuses on the first PAT based feedback control system for a fluid bed granulation batch process. Real-time particle size measurement by in-line spatial filtering technique (SFT) using a modified time-based buffer system was applied to define a target particle size after spraying a specific amount of binder solution.

Evaluation of in-line particle measurement with an SFT-probe as monitoring tool for process automation using a new time-based buffer approach.

The Process Analytical Technology (PAT) initiative published by the Food and Drug administration (FDA) describes PAT systems as important tools to optimize pharmaceutical processes in order to ensure the final product quality. Real-time particle size measurements provide a promising approach for process automation of fluid bed granulation processes. This work focuses on the introduction and evaluation of a new time-based buffer approach for in-line spatial filtering technique (SFT) in order to provide a minimum time delay of the real-time measurement.

Using 3D Printing for Rapid Prototyping of Characterization Tools for Investigating Powder Blend Behavior.

There is an increasing need to provide more detailed insight into the behavior of particulate systems. The current powder characterization tools are developed empirically and in many cases, modification of existing equipment is difficult. More flexible tools are needed to provide understanding of complex powder behavior, such as mixing process and segregation phenomenon.

In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir.

Aims: The palatability of a new paediatric formulation of valaciclovir was assessed in children and their parents: non-inferiority of the new paediatric formulation (test formulation) compared to the reference formulation was investigated.

Methods: In vivo palatability testing was performed in a randomized, two-period, multicentre, cross-over study. Children and their parents scored the liking of the new paediatric valaciclovir formulation and the reference formulation on a 100 mm visual analogue scale (VAS).

Early pediatric formulation development with new chemical entities: Opportunities of e-tongue besides human taste assessment.

The palatability of a pediatric drug formulation is one of the key prerequisites for therapeutic success. Liquid formulations are often chosen for pediatric drug products, and they require special attention regarding their taste, as they have direct contact to the taste buds and a relatively long residence time in the oral cavity. For ethical reasons, the role of electronic tongues in the development of oral drug formulations with new chemical entities (NCEs) for pediatric use is growing, however, little is known about the strategies how this instrumental taste assessment can be performed.

Critical view on drug dissolution in artificial saliva: A possible use of in-line e-tongue measurements.

Proper monitoring of drug's dissolution is a prerequisite for assessing of taste masking efficacy of pharmaceuticals. Corresponding dissolution procedure is likely to be performed with water. Since the objective of these tests is to examine fate of a pharmaceutical formulation in oral cavity, this choice of solvent seems unsuitable because physical and chemical properties of human saliva are quite far from those of water.

Data for a pre-performance test of self-developed electronic tongue sensors.

This article presents data, which can be applied for a pre-performance test of self-developed electronic tongue sensors. Contained data is related to the research article "Impact of Sodium Lauryl Sulfate in oral liquids on E-Tongue Measurements" (http://dx.doi.

Impact of sodium lauryl sulfate in oral liquids on e-tongue measurements.

During development of oral liquid medicines taste assessment is often required to evaluate taste and taste masking. Electronic tongue analysis can provide taste assessment of medicinal products but should only be conducted with medicines that interact with the instrument without damaging the sensor membranes or interfering with their electrical output so that robust data is generated. To explore the impact of a substance deemed unsuitable for electronic tongue analysis the influence of the anionic surfactant sodium lauryl sulfate (SLS), on the performance of the electronic tongue was conducted using electronic tongues equipped with self-developed PVC based sensors.

Taste-masking properties of solid lipid based micropellets obtained by cold extrusion-spheronization.

Taste-masked properties of micropellets based on hard fat and/or solid lipid mixtures (prepared by solvent-free cold extrusion/spheronization), containing metformin hydrochloride were investigated. An in-line and an on-line drug release profile evaluation of the pellets was performed and further correlated with an electronic tongue investigation. The pellets based on more than 30% of lipid binders showed metformin HCl releases below 10% after 30s of dissolution.

Suitability of E-tongue Sensors to Assess Taste-Masking of Pediatric Liquids by Different Beverages Considering Their Physico-chemical Properties.

Manipulation of liquid oral drugs by mixing them into foodstuff is a common procedure for taste-masking of OTC pharmaceuticals when administered to children. However, the taste-masking capability of such application media is not systematically evaluated, and recommendations for suitable media are hardly published. In this study, a sensor array of commercially available and self-developed electronic tongue sensors was employed to assess the taste-masking efficiency of eight different beverages (tap water, apple juice, carrot juice, fennel tea, fruit tea, milk, cocoa, and Alete meal to drink) on the OTC pharmaceuticals Ambroxol-ratiopharm®, Cetirizin AL, and Laxoberal® by multivariate data analysis.

A new biorelevant dissolution method for orodispersible films.

Specific knowledge about the dissolution behavior under biorelevant conditions is of high interest for the rational development of orodispersible films (ODFs). As the conditions in the oral cavity strongly differ from those in the gastrointestinal tract and from those performed with the pharmacopoeial test setups, a biorelevant dissolution setup was developed in this work, considering the mechanical force of the tongue, the saliva flow, the small fluid volume and the saliva composition. Especially in the initial phase, dissolution profiles of KTP (ketoprofen) ODFs observed by the new method showed a slower drug release than obtained with setups based on conventional dissolution methods.