title: Factors affecting defining the quality and functionality of excipients used in the manufacture of dry powder inhaler products.
abstract: The successful manufacture of a regulatory approved dry powder inhaler (DPI) product is only achievable by applying robust control systems to all aspects of analytical, engineering, and material based processes. Whilst many aspects of DPI drug product manufacturing can be adequately controlled, it is often the control of materials, that is, drug substance and excipients, which can lead to variation in the quality of the final drug product. This article gives an overview of DPI excipients and highlights the challenges of defining and, importantly, understanding the relationships between quality and functionality for excipient components in DPI formulations.
authors.affiliation: Inhalation and Device Development, Novartis Pharma AG, Basel, Switzerland. stephen.edge@novartis.com
authors.forename: Stephen
authors.initials: S
authors.lastname: Edge
authors.forename: Stefan
authors.initials: S
authors.lastname: Mueller
authors.forename: Robert
authors.initials: R
authors.lastname: Price
authors.forename: Jagdeep
authors.initials: J
authors.lastname: Shur
mesh_terms: D005079:Excipients / Q000737:chemistry* / Q000592:standards; D009330:Nebulizers and Vaporizers; D011208:Powders / Q000737:chemistry*
chemical_list: D005079:Excipients; D011208:Powders