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Catalent Pharma Solutions uses Malvern Spraytec for routine screening of
nebulizer formulations
5 June 2009: Malvern, UK: A cross-validation study by Catalent Pharma Solutions
has shown the Malvern Spraytec laser diffraction-based particle size analyzer to
be a robust, efficient and cost-effective alternative to cascade impaction
techniques for routine screening of nebulizer formulations. The study was
conducted by researchers from Catalent’s Respiratory, Analytical and
Biotechnology group, based in North Carolina’s Research Triangle Park (USA).
In the Catalent study, which was first presented at Drug Delivery to the Lungs
19 (DDL19, Dec 08, Edinburgh, Scotland) both the Spraytec and the Next
Generation Impactor (NGI) were used to determine the particle size distributions
of two formulations delivered from two different nebulizers. Results from both
measurement techniques for the fine particle fraction – the fraction of a dose
that deposits in the lungs – were equivalent, demonstrating that the
complementary technique of particle size analysis by laser diffraction is
directly comparable with cascade impactor measurements.
The use of particle sizing techniques is critical in understanding inhaled drug
and device performance. While cascade impactor testing remains essential for
validation and submission purposes, the results of the study show that laser
diffraction can be used for routine testing. It offers fast, efficient access to
the information needed to quantify device/formulation performance and to assess
the ranges available for safe and effective development as encouraged by QbD. As
such it is a valuable tool for cutting the costs and timelines associated with
inhalation product development.
Spraytec offers the robust operation and rapid data acquisition needed to
reliably measure aerosolized droplet size distributions in real-time during
spraying. Measurements can be carried out very rapidly and over a broad range of
particle sizes (typically 0.1 – 2000 microns), delivering detailed dynamic
information. www.malvern.com/spraytec
Malvern and, Malvern Instruments are registered trademarks of Malvern
Instruments Ltd
Spraytec is a trademark of Malvern Instruments Ltd
Ends
High resolution image attached or available from Trish Appleton,
Kapler Communications
trish@kapleronline.com Ref: MAL/JOB/1713
CAPTION: The Spraytec laser diffraction particle size analyzer designed
specifically for spray measurement
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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