Inhalation

INH0824

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This section provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No endorsement or preference is intended. ISSUE FOCUS Particle Characterization 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. Inhalation August 2024 19 Next Generation Impactor Trusted by the world's leading OINDP companies and global regulators, Copley's Next Generation Impactor (NGI) is a high-performance, precision cascade impac- tor that supports all pharmacopoeia-specified flow rates. Expertly manufactured to a durable design specification, with compliance and quality at the core, the Copley NGI delivers reliable data for superior in vitro characterization. Understanding and controlling the aerodynamic particle size distribution (APSD) of your orally inhaled and nasal drug products (OINDPs) is crucial, and the Copley NGI provides precise APSD measurement, verifying parti- cles that fall within the 1-5 micron range. Learn more here: https://www.copleyscientific.com/inhaler-testing/ aerodynamic-particle-size-distribution-apsd/ Copley Scientific UK: +44 1159 616229 info@copleyscientific.com www.copleyscientific.com Determining APSD with the NGI/NGI+ ere are various methods for determining the aerody- namic particle size distribution (APSD) of aerosols, with cascade impactors being the industry standard. ese devices are essential for quantifying the mass balance of the drug and ensuring that the particle size distri- bution remains consistent across the inhaler lifespan. MSP's Next Generation Impactors (NGI and NGI+) are manufactured with the highest precision to control nozzle dimension, which is critical for optimal perfor- mance. is offers you confidence in the data generated, along with ease of use and higher throughput in sample preparation, aiding both development and quality control applications. https://tsi.news/3xtcWZ7 MSP™, a Division of TSI ® US: +1 651 287-8100 mspsales@tsi.com www.tsi.com Best practices, new tests and technologies Partnering with Proveris Laboratories ensures use of industry best practices, the expertise to interpret results, and access to new technologies to accelerate orally inhaled and nasal drug product (OINDP) development. e Proveris by Design™ process, employed by Proveris Labo- ratories, creates the shortest path to submission for clients. By regularly integrating new tests and technologies such as spray velocity, evaporation fraction and human-realistic regional deposition, clients evaluate products according to the most current regulatory guidance documents and adapt development needs for product success. Learn about these techniques and see published data on the Proveris website: https://bit.ly/4bPeLyT Proveris Laboratories US: +1 508 460-8822 contactus@proveris.com www.proveris.com

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