Jul 16 2008
The Morphologi high sensitivity particle characterization system from Malvern Instruments has slashed the time required to analyze particles in a pharmaceutical ointment from 2 hours to just 15 minutes.
The commercially available ointment contains needle-shaped particles of active pharmaceutical ingredient in a paraffin-based formulation. Microscopy-based quality control specifications for the product require that in a 3 mg sample there are no particles longer than 250 µm, and not more than 100 particles over 100 µm. With traditional manual microscopy, analysis can take well over 2 hours per sample. Using the Morphologi this was reduced to less than 15 minutes.
Morphologi provides microscope quality images and delivers statistically significant data through the rapid analysis of hundreds of thousands of particles, with little or no user intervention. It gives information on both particle size and shape. As a result it identifies, measures, counts and classifies these needle-shaped crystals in a manner that avoids human subjectivity. In contrast to manual microscopy, where only a small number of representative fields can be photographed, Morphologi also maintains a permanent record of every measured particle.
The automation of QC microscope methods such as this eliminates analyst-to-analyst and even site-to-site variability. It can improve lab throughput and reduce measurement times without compromising the integrity of the analytical procedure. In addition, the ability to classify on the basis of both size and shape is valuable in allowing formulators to more closely tailor QC specifications to product performance