Industry guidance for the selection of a delivery system for the development of novel respiratory products

Abstract

Introduction: Respiratory diseases remain a target for improved forms of inhalation therapy. However, there are neither regulatory preferences for one type of device over another, nor well-recognized guidelines. This guidance describes factors that should be considered to optimize the choice of delivery system.

Areas covered: This article summarizes the different types of delivery systems with key technical and commercial considerations for selection. It highlights current market trends and opportunities for the future, based on the author's experience of more than 20 years in this field.

Expert opinion: For a generic drug, low device cost favors a capsule dry powder inhaler (DPI) or a propellant-based metered-dose inhaler (pMDI). Novel particle engineering approaches may allow close matching to the innovator product performance. For novel drugs, most companies favor a bespoke DPI, adding patent protection and aiding brand recognition, despite being expensive to develop. Device features may add differentiation, but "no outcome, no income." Patient technique and adherence remain problematic, compounded by age, although accessories, including monitors, can help. There are few modern medicines available in nebulized form, so there is value in fast-tracking the nebulized formulations from Phase I studies through to market in parallel to the chosen inhaler.

Keywords: asthma; chronic obstructive pulmonary disease; inhalers; nebulizers; review.