The Sysmex FPIA-3000 Flow Particle Image Analyzer from Malvern Panalytical is being used to help improve the manufacture of an inhaled drug product administered via a nebulizer. 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 administration of the drug.
Modifying the process to eliminate the source of these particles improves the efficiency of drug delivery since larger particles will not be successfully emitted by the nebuliser or deposited in the lung.
The Sysmex FPIA-3000 uses advanced imaging technology to provide size and shape distributions for each sample measured, along with a scattergram which depicts the size versus 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 characterizing problematic particles, it becomes 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 homogenization.
Analysis of a sample on the FPIA- 3000 takes only 2.5 minutes and repeat measurements can easily be set up in the standard operating procedure (SOP). This combination of features, speed and accuracy make this the ideal system for both pharmaceutical research and quality control.