Contributing to the poster presentations at the 2009 AAPS Annual Meeting and
Exposition (8-12 November 2009: Los Angeles, USA), researchers from Solvay Pharmaceuticals
Inc and Malvern
Instruments will present details of a study to examine particle size, shape
and distribution data for equivalency testing of a highly cohesive drug substance
manufactured at two different sites.
Using Malvern’s Morphologi G3 automated image analysis system for particle
characterization, the team looked at the effects of different dispersion conditions
including dispersion pressure, foil thickness, dispersion apparatus, and evaporative
techniques. The results were compared with data from optical microscopy and
laser light scattering methods. The authors go on to discuss the importance
of method development in determining the techniques and parameters necessary
to generate reproducible and accurate data. They highlight the usefulness of
the Morphologi G3’s ability to selectively filter data, ensuring that
analyses are performed only on the particles of interest.
Automated image analysis using the Morphologi G3 offers high resolution measurement
of particle size and particle shape through direct image capture. It delivers
excellent results for a wide range of particle sizes, typically from below 1
µm up to several thousand. It is ideal for many sample types including
those, such as dry powders, creams and gels, and particles on filters, that
may be difficult to characterize by other means.
The system will be demonstrated on the Malvern Instruments Booth # 813, together
with the latest Zetasizer systems for the measurement of proteins and nanosized
particles, and Malvern’s advanced range of Viscotek Gel Permeation/Size
Exclusion chromatography systems for protein and polymer analysis. Visitors
will be able to explore other systems in the Malvern materials characterization
range via interactive displays on the booth. Malvern specialists will be available
throughout to discuss individual material characterization needs. www.malvern.com
Malvern, Malvern Instruments and Morphologi are registered trademarks of Malvern
Instruments Ltd