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Image Analyzer Identifies Oversized Particles in Inhaled Products The Sysmex FPIA-3000 flow particle image analyzer from Malvern Instruments can 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 analyzer 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 because larger particles will not be successfully emitted by the nebuliser or deposited in the lung.
The instrument uses advanced imaging technology to provide size and shape distributions for each sample measured, along with a scattergram that 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, users can 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 takes only 2.5 min, and repeat measurements can easily be set up in the standard operating procedure (SOP).
Malvern Instruments Inc.*
117 Flanders Road
Westborough MA 01581
Phone: 508-768-6400
Fax: 508-768-6403
http://www.malvern.com
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