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ChemImage and Next Breath Structure Partnership to Validate Bioequivalence Testing for Nasal Spray Suspensions
Date:4/1/2009

Testing Will Help Advance Technology to Find a Faster, More Accurate and Repeatable Method for Drug-Particle Sizing

PITTSBURGH, April 1 /PRNewswire/ -- ChemImage, (www.chemimage.com) today announces a strategic research partnership with Next Breath, LLC (www.nextbreath.net), a leading Contract Research Organization (CRO) to further validate ChemImage's Raman Chemical Imaging for bioequivalence applications for nasal spray suspensions.

Baltimore, MD-based Next Breath focuses on conducting in vitro bioequivalence testing for nasal sprays and chemistry, manufacturing and controls (CMC) testing for inhalation and nasal spray products, and is particularly interested in advancing the technology to find a faster and reproducible method for drug-particle sizing relative to bioequivalence studies for nasal spray suspensions.

"We are proud to partner with Next Breath because our goal at ChemImage is to validate our bioequivalence testing methodology," said Ryan Priore, Senior Scientist, ChemImage. "Pharmaceutical companies, particularly generic drug manufacturers focused on nasal spray suspensions, are looking to improve their time-to-market through the use of better imaging technology. The potential payoff is a faster, more accurate and safe way to bring the drug to market."

ChemImage, one of the world's leading chemical and biological imaging technology solutions companies, will be partnering with Next Breath to compare optical microscopy to Raman Chemical Imaging, specifically ChemImage's FALCON II(TM) Wide-Field Raman Chemical Imaging System.

The FALCON II enables drug manufacturers to perform chemical imaging of particles in droplets to distinguish the identity, particle size distribution of drug and other substances, aggregation, and the correlation about the location of the material in the formulation -- something drug makers have been unable to achieve in the past with standard optical microscopy as part of bioequivalence testing.

"Clearly, ChemImage has the potential to advance the ability of drug manufacturers to more accurately assess their risk when going into clinical trials by providing them with a more objective active ingredient particle size analysis between the Test and Reference Drug Product. Our work with ChemImage will help validate their Raman Chemical Imaging technology and services to perform in vitro drug particle size distribution measurements," said Julie Suman, President, Next Breath, LLC.

ChemImage's FALCON II is currently available for sale across international markets. ChemImage also offers imaging lab services for companies interested in expediting bioequivalence testing. The company expects the additional validation testing to be conducted in 2009 and 2010.

ChemImage and Next Breath will be attending the Nasal Drug Delivery Conference on April 1st - 2nd, 2009 in London.

About Next Breath

Next Breath is a contract services provider for pharmaceutical, biotech and medical device companies that bring new inhalation and nasal products to market. The company provides an array of in-vitro services, from pre-clinical formulation development to analytical testing in support of submissions to regulatory agencies. Its mission is to serve as an effective liaison between innovators of promising drug molecules and inventors of pulmonary and nasal drug delivery devices.

About ChemImage

ChemImage Corporation, headquartered in Pittsburgh, is a world leader in Chemical Imaging technologies; provides instrumentation, software, lab services and expert consulting to government, industrial and academic organizations. ChemImage offers these products and services for a range of applications including defense, security, pharmaceuticals, forensics and biomedical diagnostic research. Its state-of-the-art Chemical Imaging technology can help to reveal critical chemical and biological information about processes, products and services.


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SOURCE ChemImage
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