Dry Powder Inhalers: Annual Conference
The second generation of DPIs have become either established on the market or are a signi cant way along the approval process. These have been a great success story in improving inhaled drug delivery. However, we now have to tackle the technical and regulatory issues with ‘generic’ inhalers and their approval. The development of triple therapies is well underway, these bring about their own challenges of formulation and bioequivalence. Amazingly, new DPIs are still being created, with some moving in to development programs. Furthermore, one of the areas where much study and recent guidance has been applied is in considering the patient use, compliance and human factors associated with DPIs. These linked topics are creating a whole new area that requires better understanding during product development and associated studies.
This conference aims to: address many of the issues around generic inhalers, provide case studies of bioequivalence testing, focus on the difficult formulation challenges and the strategies used so that they may be overcome, and to discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.
Conference programme to include
- personalised medicine approach to the design of dry powder inhalers n Novel DPI delivery platforms
- In-vivo extra ne particles
- High dose delivery utilising a DPI
- The next generation combinations
- Connected DPI devices
- New medical device and combination product regulations on DPI development
- Human factors in the design of DPIs
- Challenges with generics
- The use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products
- Bioequivalence research with the FDA
- Get it right: 100% in-line veri cation of dosed mass in inhalation devices n Developing inhaled Lactose formulations