CHEMIMAGE/NEXT BREATH TO VALIDATE BIOEQUIVALENCE NASAL SPRAY SUSPENSIONS.ChemImage, Pittsburgh, has announced a strategic research partnership with Next Breath, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control (http:www.nextbreath.net), a leading Contract Research Organization (CRO) to further validate ChemImage's Raman Chemical Imaging for bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. applications for nasal spray Nasal sprays are used for the nasal delivery of a drug or drugs, generally to alleviate cold or allergy symptoms such as nasal congestion. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump suspensions. Baltimore, MD-based Next Breath focuses on conducting in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. bioequivalence testing for nasal sprays and chemistry, manufacturing and controls (CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. ) testing for inhalation and nasal spray products, and is particularly interested in advancing the technology to find a faster and reproducible method for drugparticle 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 generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. 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 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 The particle size distribution[1] ("PSD") of a powder, or granular material, or particles dispersed in fluid, is a list of values or a mathematical function that defines the relative amounts of particles present, sorted according to size. 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 An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one 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. 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. For more information, call 443/543-5809. 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 See computer forensics. and biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. diagnostic research. Its state-of-the-art Chemical Imaging technology can help to reveal critical chemical and biological information about processes, products and services. For more information, visit http://www.chemimage.com or call 412/241-7335, ext. 269. |
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