The Sysmex FPIA-3000 flow particle image analyser from Malvern Instruments is being used to help improve the manufacture of an inhaled-drug product administered via a nebuliser.
By enabling fast, repeatable measurements of the size and shape of particles in suspension, the Sysmex FPIA-3000 can be used during manufacturing to detect the presence and nature of large particles that may not be dispersed during the administration of the drug.
Modifying the process to eliminate the source of these particles improves the efficiency of drug delivery as larger particles will not be successfully emitted by the nebuliser or deposited in the lung, according to Malvern.
The Sysmex FPIA-3000 uses advanced imaging technology to provide size and shape distributions for each sample measured, along with a scattergram that depicts the size versus the shape of the particles.
If large particles are identified during the manufacturing process of inhalation drug suspensions, their recorded images can be viewed to enable distinction between primary particles, loose agglomerates and hard aggregates.
By fully characterising problematic particles, it is possible to determine whether the energy supplied by the nebuliser is likely to be sufficient for effective dispersion and, if not, to distinguish where in the process the problem arises.
For example, large primary particles may be an indication of ineffective homogenisation.
The analysis of a sample on the FPIA-3000 takes two-and-a-half minutes and repeat measurements can be set up in the standard operating procedure.
This combination of features, speed and accuracy makes the system suitable for both pharmaceutical research and quality control.
