CHARACTERIZATION OF NANO-SCALE PHARMACEUTICAL POWDERS *

DESCRIPTION (provided by applicant): This project proposes to further develop and test Synergetic Technologies (Synergetics) novel system for characterizing pharmaceutical powders and their agglomerates. Nanopowder drug formulations exhibit increased bioavailability and offer unlimited potential for drug delivery. Unfortunately, they are difficult to stabilize due to their great surface area and propensity to agglomerate. On-line characterization, an important consideration for drug development and quality, is a major challenge for ultra-fine pharamceutical powders. This fact is underscored by the willingness of a number of drug companies that participate in this project. Based on successful characterization studies of nano and submicron ceramic powders, Synergetics intends to develop a customized pharmaceutical powder characterization tool which will determine particle size, shape, and agglomerate structure from the nano to micro size range. Tasks are focused on development of a customized, information-rich instrument, which will be of great value to the pharmaceutical industry. Phase II will involve construction and testing of prototype devices, extension of important particle dispersion studies begun in Phase I, and on-site testing at pharmaceutical laboratories that have expressed keen interest in employing this technology. This project is a critical step in development and will provide the framework for Phase Ill commercialization. Potential customer interest has been keen, as evidenced by the financial commitments of Phase II and Phase III partners. Manufacturing and licensing plans are well form and will materialize as this project gets underway. Strategic partners include a potential manufacturer and seller (Thermo Oriel-an established leader in photonics manufacturing and sales), major pharmaceutical companies who see great potential value in this technology (Glaxo-Smith-Kline, Elan Pharmaceutical Technologies, Boehringer-lngelheim, and ASSCI) and expert particle characterization scientists from Columbia University and the University at Albany. PROPOSED COMMERCIAL APPLICATION: A vast market exists for instruments provising on-line characterization of pharmaceutical powders. The emergence of nano-size powders for advanced drug delivery introduces new demands and, consequently, a lucrative business opportunity for Synergic Technologies. Additional applications for this technology include advanced materials, consumer products and food processing, and environmental monitoring.