Inhalation

INH0617

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Glass expansion chambers Copley Scientific offers a range of glass expansion chambers for nasal spray and aerosol testing in accordance with US FDA bioequivalence guidance, for quan- tifying the amount of drug present in particles or droplets less than approximately 10 microns in size. Such particles, because of their size, may penetrate beyond the nasal passageways and inadvertently deposit in the lung. The glass expansion chambers are available in three sizes: 1,000 mL, 2,000 mL and 5,000 mL, with the smallest chamber preferred for nasal aerosols and the two larger for nasal sprays. Associated adapters ease connection to specific devices and to either the Andersen Cascade Impactor (ACI) or the Next Generation Impactor (NGI) for aerodynamic particle size distribution measurement. Copley Scientific UK: +44 1159 616229 www.copleyscientific.com Inhalation JUNE2017 19 Accelerating drug product development Next Breath is a full-service, cGMP- compliant laboratory that special- izes in the analytical testing of drug delivery systems. From providing comprehensive solutions for prod- uct development to batch release and post-approval stability studies, Next Breath works with customers at each step of the process to ensure the highest quality of analytical analysis for MDIs, DPIs, nebulizers and nasal drug products while meet- ing regulatory demands. Next Breath US +1 410 455-5904 www.nextbreath.net Fast-screening impactor (FSI) MSP developed the Model 185 fast-screening impactor (FSI) in 2008 for R&D and QbD applications. Based on proven Next Generation Impactor (NGI) technology, the FSI is an easy-to-use, versatile instru- ment that enables users to quickly, accurately and reliably determine the fine particle dose (FPD) of MDIs, DPIs and nasal aerosols and sprays. Users can specify flow rate (15-100 L/min) and cut (1.5, 4.7, 5.0, 10 micron or custom). The FPD is collected within an external filter holder, with quick-release latches for rapid removal of the filter holder for gravimetric or chemical analysis. MSP Corporation US: +1 651 287-8100 www.mspcorp.com Nasal formulation and analytical development Catalent provides full nasal formu- lation, analytical development and clinical manufacturing services for liquid- and powder-based unit dose and bi-dose systems, including potent and controlled drug com- pounds. Supported by a compre- hensive suite of analytical instru- mentation, Catalent offers routine nasal testing as well as full product characterization studies required by regulatory guidance. With non- GMP and GMP facilities, Catalent provides filling for formulation fea- sibility testing and evaluation as well as supporting clinical and com- mercial supply. Catalent Pharma Solutions US: +1 888 SOLUTION www.catalent.com

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