Malvern and Next Breath Workshop at RDD 2013 Links Dissolution and Particle Size via Raman Imaging

Malvern Instruments is joining forces with contract services organization Next Breath, which specializes in inhaled product development, to present an interactive workshop at Respiratory Drug Delivery 2013 (RDD 2013), which takes place in Berlin, Germany from 21-24 May 2013. The workshop, ‘Linking Dissolution and Particle Size via Raman Imaging’, runs on 22 May and examines the application and benefits of morphologically directed Raman spectroscopy for characterizing inhaled products. The presenters will focus on the correlation of in vitro dissolution of suspension nasal spray and inhalation drug products with ingredient-specific particle size analysis. The session will involve a demonstration of Malvern’s Morphologi G3-ID, a system that combines automated imaging with the chemical identification of individual particles using Raman spectroscopy.

The Morphologi G3-ID enables the efficient direction of spectroscopy to particle populations of interest, classified on the basis of particle size and shape. This makes it a valuable tool for the analysis and development of complex, multicomponent inhalation drug dispersions.

Workshop participants will learn how the Morphologi G3-ID helps provide evidence of bioequivalence and can advance the drug validation process through supporting the use of biowavers. Biowavers apply in regulatory drug approval processes where the efficacy and safety sections of the validation process can be approved based on in vitro equivalence testing Case study evidence will relate the in vitro dissolution behavior of drug product to component-specific particle size data gathered using the Morphologi G3-ID. There will also be guidance on the fundamentals of using this powerful particle characterization technique, including hints and tips on sample preparation and analysis.

By combining particle imaging with Raman spectroscopy, the Morphologi G3-ID enables size, shape and chemical identification in a single instrument. Able to measure particles across the size range 0.5 microns to several millimeters, the instrument captures images of individual particle species using powerful optical technology. The resulting data enable the classification of particles on the basis of size and shape, ahead of analysis with Raman spectroscopy, which delivers chemical characterization. These capabilities make Morphologi G3-ID a powerful tool for the development of suspension nasal sprays and dry powder inhaler formulations, where it enables targeted quantitative, physical and chemical characterization of the active pharmaceutical ingredient within a blend.