Gesine Winzenburg

Playing hide and seek with poorly tasting paediatric medicines: Do not forget the excipients☆

The development of paediatric medicines can be challenging since this is a diverse patient population with specific needs. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Acceptable palatability of oral paediatric medicinal products is of great importance to facilitate patient adherence. This has been recognised by regulatory authorities and so is becoming a key aspect of paediatric pharmaceutical development studies. Many active pharmaceutical ingredients (APIs) have aversive taste characteristics and so it is necessary to utilise taste masking techniques to improve the palatability of paediatric oral formulations. The aim of this review is to provide an overview of different approaches to taste masking APIs in paediatric oral dosage forms, with a focus on the tolerability of excipients used. In addition, where possible, the provision of examples of some marketed products is made.

Interlaboratory testing of Insent e-tongues

The first interlaboratory testing of electronic taste sensing systems was performed within five participating centers, each working with the Insent (Insent Inc., Atsugi-Shi, Japan) e-tongue. Preparation of the samples for the comprised four experiments, shipping of the samples and evaluation of the results was performed at the University of Duesseldorf. The sensitivity (in this case the difference between lowest and highest sensor response) and slope of the regression line values, obtained within Experiment 1 and 2, have been found to serve as applicable evaluation criterions for interlaboratory comparability. Modified sensor responses could be attributed to aged sensors, but did not influence the results of either Experiment 3, dealing with the evaluation of film formulations, or Experiment 4, dealing with the evaluation of minitablet formulations, in a great amount. Presented PCA Score and Loading Scatter Plots as well as Euclidean distance patterns based on the raw sensor responses confirmed the comparable performance of Insent e-tongues of the participating centers.

More than 5 years of European Paediatric Regulation: statistics and industrial experience.

The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines. One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU. A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.