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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. ProDuct DEVELoPMENt Inhalation April 2020 27 Pre-formulation and formulation capabilities Catalent provides a full suite of pre-formulation and formulation capabilities including screening of optimal API forms (polymorph, salt, co-crystal); physicochem- ical characterization; API compatibility in aqueous, propellant-based and dry powder formulations; API performance optimization (solubility, viscosity, parti- cle size reduction, droplet size distribution, etc.); nasal and oral inhalation dose forms (single- or multi-dose); and additional GLP and non-GLP development and characterization services. Whether a single service or a turn-key development solution is required, Catalent Inhalation has the capability and expertise to advance product development, from feasibility studies through registration and commercial supply. Catalent US: + 1 888-SOLUTION Testing services to support quality control Gateway Analytical is a leader in counting, sizing and identifying particulate matter in drug products throughout all stages of the lifecycle. We utilize stan- dard methods for release testing, such as microscopy and light obscuration, and support investigations when out-of-expectation particulate populations are observed. We apply a multi-analytical pharmaceutical forensics approach when identifying and sourcing for- eign particulate down to 2 ┬Ám in size. Gateway Analyti- cal is FDA-registered, cGMP compliant, DEA licensed and ISO 17025 accredited. Gateway Analytical, an Aptar Pharma Company US: +1 724 443-1900 Partnering to meet FDA reliability expectations Next Breath is a full-service, cGMP-compliant lab- oratory specializing in the analytical testing of drug delivery systems. We provide guidance and support for understanding the expectations for new combination drug products. We offer extensive services to test actua- tion force, reliability studies, in-use studies and perfor- mance during shipping. Our team of dedicated scien- tists can help you navigate these distinct expectations, even during investigational new drug applications. Next Breath, an Aptar Pharma Company US: +1 410 455-5904

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