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Malvern’s chemical imaging system helps solve a major challenge in
paediatric drug development
5 November 2009: Malvern, UK: Researchers at the Institute of
Pharmaceutics and Biopharmaceutics at the University of Düsseldorf in Germany
have taken delivery of a Near Infrared Chemical Imaging (NIR-CI) system from
Malvern Instruments (Malvern, UK). Able to deliver rapid, robust and flexible
spatial and chemical information, the Sapphire system was selected for its wide
sampling dynamic range and depth of field. The ideal solution for analyzing
curved tablets, whole granules and pellets, and anything in between, the new
instrument is set to transform many of the Institute’s ground-breaking projects
in novel solid drug dosage forms. The system is already being used by Prof. Dr.
J. Breitkreutz and his research team for testing oral drug-loaded films, also
called wafers, in a project designed to tackle the difficulties of administering
drugs to young children.
Prof. Dr. Jörg Breitkreutz said; “Paediatric drug delivery is a major challenge.
There is currently a lack of suitable and safe solid drug formulations for
children and new EU legislation will enforce paediatric clinical trials and drug
development. Current advances in this area include interesting new drug delivery
concepts such as multiparticulate dosage forms, minitablets, fast-dissolving
formulations, small-sized oral films and wafers designed to stick to the roof of
the patient’s mouth. However, novel dosage forms often need special methods to
assess their properties for both development and quality control as standard
testing procedures are not available in the pharmacopoeias. This increases the
need for flexible analytical methodology and instrumentation. Malvern’s near
infrared chemical imaging system accommodates the sample variability encompassed
by modern pharmaceutical development and was therefore our ideal solution for
visualization of drug distribution within the dosage forms.”
On 29th May 2009 the European Journal of Pharmaceutics and Biopharmaceutics
published a paper authored by Verena Garsuch and Jörg Breitkreutz. Entitled;
‘Novel analytical methods for the characterization of oral wafers’, the paper
describes a study that aims to compensate for the lack of adequate methods for
the characterization of the novel wafers by applying advanced analytical
techniques1. The Malvern chemical imaging system plays a critical role within
the morphological investigation as it can depict visually unrecognized
differences in the distribution of the active pharmaceutical ingredient within
wafers. Further information regarding the application of NIR-CI in
pharmaceutical development can be found at:
http://www.malvern.com/NIRCI
1 V. Garsuch, J. Breitkreutz, “Novel analytical methods for the characterization
of oral wafers”
Eur. J. Pharm. Biopharm. 73:195-201 (2009)
Malvern, Malvern Instruments and SyNIRgi are registered trademarks of Malvern
Instruments Ltd
High resolution image attached or available from Trish Appleton,
Kapler Communications
trish@kapleronline.com Ref: MAL/JOB/1857
CAPTION: NIR chemical image of caffeine-loaded oral film. Red pixels indicate
high concentrations of caffeine in the matrix of excipients and isolated red
dots advancing crystallization of caffeine.
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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