Outcome of a questionnaire within European pharmaceutical aerosol group (EPAG) companies concerning the implementation of the abbreviated impactor measurement (AIM) concept for the assessment of orally inhaled product (OIP) aerosol aerodynamic particle size properties

Abstract

The AIM Concept as an augmentation of full resolution cascade impactor (CI) measurements of the aerodynamic properties of aerosols emitted by OIPs has been in existence for about ten years. A previous EPAG-based survey undertaken five years ago indicated significant interest in the approach, particularly for the screening of candidate products in early stage product development. We report the outcome of a further questionnaire with the goals of establishing: (a) the types of AIM-based equipment currently in use; and (b) insight into perceived hurdles towards full implementation within the product lifecycle. Responses were received in October 2016 from 17 out of 22 organizations from people involved directly with the in vitro testing of pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products. The survey has shown that the AIM concept has sufficient popularity within the EPAG respondent organizations to be considered a viable augmentation to existing full resolution CI methodology. The main conclusions are: (1) The Fast Screening Andersen (FSA), reduced Next Generation Impactor (rNGI) and Fast Screening Impactor (FSI) are all used as AIM-based impactor configurations for both dry powder inhaler (DPI) and pressurized metered dose inhaler (pMDI) applications; (2) AIM-based methods are used almost entirely for the early development phase of the OIP life cycle; (3) Organizations in general do not have confidence to use the AIM concept more widely in the product life cycle whilst no compendial/regulatory guidance is available to provide standard procedures and precautions/regulatory acceptance respectively