What happens when biopharmaceutics meets inhaled drug delivery?

07Dec2022

The audience found out during our presentation at DDL 2022 in Edinburgh, Scotland. (https://ddl-conference.com/)

Summary: The delivery of an inhaled drug is influenced by several factors including its physicochemical properties, lung deposition and disposition. Each of these properties is influenced by underlying factors such as the formulation, the delivery device, and the physiology, anatomy and pulmonary function of the patient. The assessment of an inhalation-based classification system (iBCS) has progressed since the concept was first introduced at an AAPS workshop in 2014. The principles of the proposed iBCS are based on those used for the classification of oral immediate release drugs (giBCS) and therefore are well established. On the other hand, the framework of the iBCS needs to be altered from that used in the giBCS providing a route-specific framework encompassing the intricacies of pulmonary physiology. The premise for the proposed classification system is that it is desirable from a drug discovery, development, and regulatory perspective to anticipate the behavior of inhaled drugs. Our proposal is that a qualitative classification of a drug based on a classification system constructed from critical drug attributes will aid in understanding how to reduce the risk and overall complexity of inhaled drug product development, scale-up, and post-approval changes.