Researchers from Solvay Pharmaceuticals Inc. have used the Morphologi G3 image analysis based particle characterization system from Malvern Instruments to examine an API manufactured at two different facilities to determine if—from a particle size and shape perspective—they can be seen as equivalent and be used interchangeably in commercial formulation.
This micronized, highly cohesive API tends to form aggregates, presenting a challenging dispersion problem. To achieve meaningful data and ensure examination of primary particles, it is essential to minimize aggregate formation and disperse discrete particles. A number of dispersion conditions were assessed for image analysis and data were compared with optical microscopy and laser diffraction.
Data generated from dispersions using Morphologi G3’s integral Sample Dispersion Unit (SDU) were the most consistent and reproducible, and the differences compared with other dispersion techniques demonstrated the importance of appropriate method development for any given application. Using the Morphologi G3 software, data were filtered to exclude extraneous particles so only particles of interest were counted. Filtering and classification based on particle size or shape characteristics allowed analysis of particles of interest while excluding those of no importance, in this case large aggregates. The results compared well with laser diffraction and optical microscopy particle size specifications set out by the manufacturer.
The researchers concluded that this dispersion method can be used to assess the particle size of the API for raw material release testing. The method was key in comparing APIs manufactured at two separate facilities to determine that the materials can be considered equivalent.
Date: January 14, 2010
Source: Malvern Instruments
Filed Under: Drug Discovery
