2023 年 40 巻 p. 172-185
It is well established that the critical performance metrics for aerosol products are aerodynamic particle size distribution (APSD) and delivered dose uniformity (DDU). In broad terms, these performance characteristics dictate the efficiency and reproducibility with which an aerosol is administered clinically. However, these properties alone do not support in-vitro, in-vivo correlations. There have been numerous publications attempting to more directly link product performance testing to physiological relevance or further to draw direct correlations of relevance to bioequivalence testing for the development of generic products. While these novel methods have been employed in product development activity, their suitability for compendial testing has yet to be established. This paper explores the potential to establish biologically relevant compendial standards for dry powder inhaler products while maintaining accuracy and reproducibility of data collected to support the quality and performance of the product.
