Improved Laboratory Test Methods for Orally Inhaled Products

Abstract

Existing pharmacopeial methods for the in vitro testing of orally inhaled products (OIPs) are simplified representations of clinical reality, as their objective is to provide metrics that are discriminating of product quality. Attempts to correlate measures such as fine particle fraction <5 µm aerodynamic diameter with in vivo measures of lung deposition have therefore been notoriously difficult to achieve. Although particle imaging-based techniques may be helpful to link in vitro to in vivo data as surrogates for clinical responses, a reappraisal of the purposes for laboratory-based testing of OIPs is required. This article provides guidance on approaches that may be helpful to develop clinically appropriate methods to assess OIP performance in the laboratory, with the ultimate goal of developing robust in vitro–in vivo relationships for the major inhaled drug classes.

Acknowledgments

The authors wish to acknowledge the advice and support from R Morton, J Suggett and D Engelbreth at Trudell Medical International, and D Coppolo of Monaghan Medical Corporation.

Financial & competing interests disclosure

The authors are full-time employees of Trudell Medical International, manufacturer of some of the devices identified in the article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.