16 March 2009: Malvern, UK: New work from Malvern Instruments illustrates how the complementary particle characterization techniques of laser diffraction (Spraytec) and automated image analysis (Morphologi G3) can accelerate nasal spray testing. Both methods are time-efficient, providing detailed insight for formulation development and supporting streamlined analysis for QC. A full report on the studies can be downloaded at www.malvern.com/Article_NasalSpray
FDA guidance covering bioavailability/bioequivalence studies for locally acting nasal sprays specifies that critical parameters, such as active drug particle size and droplet size, are measured to assess performance. Automated image analysis can reduce the time taken to measure drug particle size, from two hours with manual microscopy to just 20 minutes. Laser diffraction, which has a data acquisition rate of 2500 measurements per second, is able to track the evolution of formulation droplet size during a spray event, providing researchers with the results required to optimise the process of drug delivery to the nasal mucosa.
In the study, an existing manual microscopy method was transformed into a standard operating procedure for the Morphologi G3, Malvern's fully automated particle characterization system that uses image analysis technology. Size and shape data were rapidly captured for a considerably greater number of active drug particles compared to the existing manual method, giving the data greater statistical relevance. Powerful classification software defined the particle populations of interest and eliminated data for active-excipient agglomerates. Automating the entire analytical process not only accelerates measurement, it also removes any operator bias.
Using the Spraytec laser diffraction system, the evolution of droplet size can be tracked in real time during the actuation of a nasal spray pump. This capability was used to quantify the impact of solution viscosity on the size of droplets produced during aerosolization. The results show that more viscous solutions produce a larger droplet size. Spraytec is suitable for the in situ measurement of suspension or solution droplets in the size range 0.1 to 2000 microns, making it ideal for the analysis of nasal sprays and orally inhaled products.
To view the full report visit www.malvern.com/Article_NasalSpray
About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).
Particle size, particle shape, zeta potential, molecular weight, chemical composition and rheological properties measurements are now joined by advanced chromatography solutions (GPC/SEC), extending Malvern's technologies for protein molecular weight, size and aggregation measurements, and synthetic polymer molecular weight and distribution. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.
Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com
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