Malvern’s chemical imaging system helps solve a major challenge in paediatric drug development

Researchers at the Institute of Pharmaceutics and Biopharmaceutics at the University of Düsseldorf in Germany have taken delivery of a Near Infrared Chemical Imaging (NIR-CI) system from Malvern Instruments (Malvern, UK). Able to deliver rapid, robust and flexible spatial and chemical information, the Sapphire system was selected for its wide sampling dynamic range and depth of field. The ideal solution for analyzing curved tablets, whole granules and pellets, and anything in between, the new instrument is set to transform many of the Institute’s ground-breaking projects in novel solid drug dosage forms. The system is already being used by Prof. Dr. J. Breitkreutz and his research team for testing oral drug-loaded films, also called wafers, in a project designed to tackle the difficulties of administering drugs to young children.

Prof. Dr. Jörg Breitkreutz said;

“Paediatric drug delivery is a major challenge. There is currently a lack of suitable and safe solid drug formulations for children and new EU legislation will enforce paediatric clinical trials and drug development. Current advances in this area include interesting new drug delivery concepts such as multiparticulate dosage forms, minitablets, fast-dissolving formulations, small-sized oral films and wafers designed to stick to the roof of the patient’s mouth. However, novel dosage forms often need special methods to assess their properties for both development and quality control as standard testing procedures are not available in the pharmacopoeias. This increases the need for flexible analytical methodology and instrumentation. Malvern’s near infrared chemical imaging system accommodates the sample variability encompassed by modern pharmaceutical development and was therefore our ideal solution for visualization of drug distribution within the dosage forms.”

On 29th May 2009 the European Journal of Pharmaceutics and Biopharmaceutics published a paper authored by Verena Garsuch and Jörg Breitkreutz. Entitled; ‘Novel analytical methods for the characterization of oral wafers’, the paper describes a study that aims to compensate for the lack of adequate methods for the characterization of the novel wafers by applying advanced analytical techniques1. The Malvern chemical imaging system plays a critical role within the morphological investigation as it can depict visually unrecognized differences in the distribution of the active pharmaceutical ingredient within wafers. Further information regarding the application of NIR-CI in pharmaceutical development can be found at:  http://www.malvern.com/NIRCI

1V. Garsuch, J. Breitkreutz, “Novel analytical methods for the characterization of oral wafers” Eur. J. Pharm. Biopharm. 73:195-201 (2009)

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