With the phase down of F-gases, the increased adoption of connected devices and the growing need to provide less expensive medicines to patients, the industry needs tools that can accelerate and de-risk the development of pressurised metered dose inhalers (pMDIs).
SmartTrackTM is a novel integrated solution that accelerates product development and provides an alternative bioequivalence (BE) approach to the comparative clinical endpoint. It consists of a number of in vitro and in silico techniques designed to characterize every important process that occurs from using a pressured metered dose inhaler device to delivering the drug to the patient. Furthermore, SmartTrackTM can reduce drug development timelines and hence program costs, thus accelerating new product development and regulatory decision-making.
This webinar will discuss a case study where a well-known API was reformulated into a low global warming potential (Low GWP) propellant. It will also present the challenges of reformulation when using low GWP propellants and presents the case for an integrated suite of tools to solving these challenges.
Anybody looking to achieve these goals should attend this webinar.
Key Learning Objectives
- Evaluate the key processes influencing drug delivery to the lung from a pMDI
- Assess the required standard for in vitro and in silico tools to correctly understand these processes
- See how an integrated in vitro-in silico approach can inform the development of low GWP pMDIs
- Explore the use of SmartTrack™ for pMDIs from early phase development to regulatory submission