Chemical Imaging System Helps Solve Major Hurdle in Pediatric Drug Development

New near-infrared chemical imaging (NIR-CI) technology is able to provide fast and flexible spatial and chemical information, with wide sampling dynamic range and depth of field.

Researchers from the Institute of Pharmaceutics and Biopharmaceutics at the University of Düsseldorf (Germany) have taken delivery of a near infrared chemical imaging (NIR-CI) system from Malvern Instruments (Malvern, UK). 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 groundbreaking 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, "Pediatric drug delivery is a major challenge. There is currently a lack of suitable and safe solid drug formulations for children and new EU [European Union] legislation will enforce pediatric 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 May 29, 2009, the European Journal of Pharmaceutics and Biopharmaceutics published an article that described a study that aims to compensate for the lack of adequate methods for the characterization of the novel wafers by applying advanced analytic techniques. The Malvern chemical imaging system plays a critical role within the morphologic investigation as it can depict visually unrecognized differences in the distribution of the active pharmaceutical ingredient within wafers.

Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials, and macromolecules. Analytic instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to nanomaterials and delicate macromolecules. A wide range of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).

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University of Düsseldorf
Malvern Instruments