Sysmex FPIA-3000 from Malvern Identifies Oversized Particles in Inhaled Products |
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Malvern Instruments Inc.
10 Southville Rd.
Southborough, MA, 01772
USA
Press release date: January 28, 2010
28 January 2010: Malvern, UK: The Sysmex FPIA-3000 Flow Particle Image Analyzer from Malvern Instruments 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.
For a full report of this work visit: http://www.malvern.com/fpiasuspensions
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
For press information, please contact:
Trish Appleton,
Kapler Communications
Knowledge Centre, Wyboston Lakes,
Great North Road, Wyboston,
Bedfordshire, MK44 3BY, UK
Tel: +44 (0)1480 479280;
Fax: +44 (0)1480 470343
trish@kapleronline.com
USA contact:
Marisa Fraser,
Malvern Instruments Inc.
117 Flanders Road, Westborough,
MA 01581-1042 USA
Tel: +1 508 768 6400
Fax: +1 508 768 6403
marisa.fraser@malvern.com
Please send sales enquiries to:
Alison Vines,
Malvern Instruments Ltd
Enigma Business Park, Grovewood Road,
Malvern, Worcestershire WR14 1XZ UK
Tel: +44 (0) 1684 892456;
Fax: +44 (0) 1684 892789
salesinfo@malvern.com
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