Inhalation

INH0616

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16 JUNE 2016 Inhalation ISSUEFOCUS This section of Inhalation provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No product endorsement or preference is intended. InStrUmentS Unit dose spray solutions Aptar Pharma provides the drug delivery device and regu- latory support for Adapt Pharma's Narcan ® (naloxone hydrochloride) nasal spray. Approved by the FDA and launched in the US, it is indicated for the treatment of opi- oid overdose and is equipped with Aptar Pharma's unit dose system (UDS). Aptar Pharma has brought to the partnership its unique experience in nasal drug delivery and its regulatory expertise in relation to combination drug/device products, thereby successfully supporting Adapt Pharma's new drug application. Aptar Pharma US: +1 845 639-3700 France: +33 1 39 17 20 20 www.aptar.com/pharma Photo courtesy of Adapt Pharma Fast-screening impactor (FSI) MSP developed the Model 185 fast-screening impactor (FSI) in 2008 for R&D and QbD applica- tions. Based on proven next generation impactor (NGI) technology, the FSI is an easy-to-use, versatile instrument 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 gravi- metric or chemical analysis. MSP Corporation US: +1 651 287-8100 www.mspcorp.com A complete test setup for nebulizers Copley Scientific offers all the equipment required for efficient delivered dose uniformity (DDU) testing and aerodynamic particle size distribution measure- ment (APSD) for nebulizers, in accordance with the latest pharmacopeia chapters (USP <1601>/Ph. Eur. 2.9.44). Key items include the: Next Generation Impactor (NGI) for APSD measurement at 15 L/min, NGI Cooler to prevent temperature-induced droplet evaporation, Breath Simulators BRS 1100 and BRS 2000 that simplify the application of tidal breathing patterns, and the Breath Actuation Controller BAC 2000 for timed airflow control. Copley Scientific UK: +44 1159 616229 www.copleyscientific.com. Pre-formulation to commercialization From pre-formulation to commercialization, Catalent Pharma Solutions can assist in any stage of development for inhalation and nasal drug products. Catalent's exper- tise and experience have been successfully applied to mul- tiple dosage forms, as have Catalent Micron Technology's particle size engineering capabilities, which can work to the most stringent specifications demanded by inhalation formulations. Catalent's inhalation manufacturing oper- ations have a track record of regulatory excellence and the company routinely manufactures pMDIs, DPIs and nasal formulations for clients around the globe. Catalent Pharma Solutions US: +1 888 SOLUTION www.catalent.com

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