New Studies Demonstrate The Application of Particle Characterization Systems to Inhaled Product Testing

As well as exhibiting at this year’s Drug Delivery to the Lungs conference (DDL 19, 10-12 December 2008, Edinburgh, Scotland), Malvern Instruments will participate in the scientific poster sessions. Here the company will present two new studies demonstrating the application of the Morphologi G3 and Spraytec particle characterization systems to different aspects of inhaled product testing.

One study shows that the Morphologi G3 fully automated particle characterization system slashes the time taken to accurately and reproducibly quantify Foreign Particulate Matter (FPM) in pharmaceutical inhalation products. FPM is contaminating material introduced during the manufacturing process or generated by abrasion or shearing during device activation. Its presence in inhalation products is strictly regulated so measuring FPM levels is an important QC activity. The Morphologi G3 can successfully replace manual microscopy for quantifying FPM, reducing measurement times from around a day to less than one hour. Furthermore, the analysis provides detailed information on particle morphology that makes it easier to determine the contamination source.

In the second study, undertaken collaboratively with Melbourne Scientific and Copley Scientific, Malvern’s Spraytec laser diffraction particle size analyzer was used to investigate the impact of rheological properties on nebulizer performance. Outputs from a breath-assisted jet nebulizer were examined under different breathing profiles, for a series of different viscosity solutions. The results show that structure in the fluid has a marked effect on the particle size and concentration of the delivered aerosol, providing valuable insight for optimising both device and formulation.

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