Microstructural characterization of carrier-based dry powder inhalation excipients: Insights and guidance

Publication date: Available online 28 June 2019Source: International Journal of PharmaceuticsAuthor(s): Mustafa M.A. ElsayedAbstractThe growing interest in development of dry powder inhalation (DPI) products raises a need for development of standard testing methods and specifications for DPI excipients. The pharmaceutical industry meanwhile yet lacks compendial guidance on this topic. Despite of the complexity of interactions taking place in DPI systems and the large number and variety of interplaying factors, understanding of key determinants of performance (critical quality attributes) of DPI excipients have considerably developed over the past years. In light of the current knowledge in this area, this article provides technical guidance and insights on testing and quality control of carrier-based DPI excipients, which are, typically, blends of coarse carrier particles and fine, performance-modulating particles. The article explores techniques used for measurement of key microstructural attributes, namely the particle size distribution, the porosity and the particle surface roughness, the particle shape, rheological properties, and the permeability, of these excipient materials. The technical relevance of each measurement to the functionality of the excipients is critically discussed. In this regard, caveats concerning some measurements and data analysis procedures are raised. The guidance lends itself for compendial consideration.Graphical abstract
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research