25 April 2013: Malvern, UK: Malvern Instruments is joining forces with contract services organization Next Breath, which specializes in inhaled product development, to present an interactive workshop at Respiratory Drug Delivery 2013 (RDD 2013), which takes place in Berlin, Germany from 21-24 May 2013. The workshop, ‘Linking Dissolution and Particle Size via Raman Imaging’, runs on 22 May and examines the application and benefits of morphologically directed Raman spectroscopy for characterizing inhaled products. The presenters will focus on the correlation of in vitro dissolution of suspension nasal spray and inhalation drug products with ingredient-specific particle size analysis. The session will involve a demonstration of Malvern’s Morphologi G3-ID, a system that combines automated imaging with the chemical identification of individual particles using Raman spectroscopy. To find out more about the workshop visit the RDD website: http://www.rddonline.com
The Morphologi G3-ID enables the efficient direction of spectroscopy to particle populations of interest, classified on the basis of particle size and shape. This makes it a valuable tool for the analysis and development of complex, multicomponent inhalation drug dispersions.
Workshop participants will learn how the Morphologi G3-ID helps provide evidence of bioequivalence and can advance the drug validation process through supporting the use of biowavers. Biowavers apply in regulatory drug approval processes where the efficacy and safety sections of the validation process can be approved based on in vitro equivalence testing. Case study evidence will relate the in vitro dissolution behavior of drug product to component-specific particle size data gathered using the Morphologi G3-ID. There will also be guidance on the fundamentals of using this powerful particle characterization technique, including hints and tips on sample preparation and analysis.
By combining particle imaging with Raman spectroscopy, the Morphologi G3-ID enables size, shape and chemical identification in a single instrument. Able to measure particles across the size range 0.5 microns to several millimeters, the instrument captures images of individual particle species using powerful optical technology. The resulting data enable the classification of particles on the basis of size and shape, ahead of analysis with Raman spectroscopy, which delivers chemical characterization. These capabilities make Morphologi G3-ID a powerful tool for the development of suspension nasal sprays and dry powder inhaler formulations, where it enables targeted quantitative, physical and chemical characterization of the active pharmaceutical ingredient within a blend.
To find out more about RDD 2013 visit the conference website: www.rddonline.com
To learn about Morphologi G3-ID visit the Malvern Instruments website www.malvern.com/raman
Malvern, Malvern Instruments, Morphologi are registered trademarks of Malvern Instruments Ltd.
About Malvern Instruments
Malvern provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.
Our products reflect Malvern’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.
Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.
Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com
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For press information, please contact:
Marisa Fraser, Malvern Instruments Inc.
117 Flanders Road, Westborough, MA 01581-1042 USA
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