Dry Powder Inhalers - Key Annual Conference for Pharmaceutical & Medical Device Professionals in the DPI Market (London, United Kingdom - June 24-25, 2020) - ResearchAndMarkets.com
The second generation of DPIs have become either established on the market or are a significant 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 and these bring about their own challenges of formulation and bioequivalence.
Amazingly, new DPIs are still being created, with some moving into development programmes. 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.
The Dry Powder Inhalers conference will 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 discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.
Conference programme to include:
Current and future challenges for DPI formulations
Novel DPI delivery platforms
Design and characterisation of breath actuation mechanisms
Method for the determination of delivered-dose uniformity and aerodynamic particle size distributions of DPIs
Sampling and analysis of inhalation devices in accordance with ISO 18562
Development of a new moisture-resistant DPI which performs well irrespective of orientation
How can the physicochemical properties of DPIs and their stability impact product performance?
Spray drying of nanopharmaceuticals into microsphere formulations
INFORM 2020: new analytical insights into dry powder formulations for inhalation
Dry powder formulations: from low dosage API delivery to biopharmaceuticals
Inhalation products, transitioning from less regulated markets
Challenges with generics
Overcoming the need for comparative clinical endpoint bioequivalence studies in a 505(j) ANDA weight of evidence approach for orally inhaled products
The 1nhaler and its two jobs
Opportunities and challenges in the design of a high-performance unit-dose DPI
Agenda
Programme Day One
Current and future challenges for DPI formulations
Today's DPI marketplace
The challenge of formulating new chemical entities (NCEs)
The challenge of developing generic DPIs
Quality by design in DPI formulation
Advanced manufacturing technology
Dr David Wyatt
Novel DPI delivery platforms
Marketed DPI platforms
Novel DPI platforms
Capability gaps
Value in the eyes of the consumer
Paul Johnson
Design and characterisation of breath actuation mechanisms (BAMs)
Rationale and user requirements for the use of BAMs in inhaled drug delivery products
Design considerations for BAMs
Experimental characterisation of BAMs
Comparison of the trigger characteristics in different marketed breath actuated inhaler products
James Tibbatts
Methods for the determination of delivered-dose uniformity and aerodynamic particle size distributions of DPIs
Introduction to inhaled device types and their nuances
Current regulatory requirements for in-vitro testing of DPIs
Delivered dose uniformity testing and APSD measurements by cascade impaction
Advances in measurement techniques for bioequivalence testing and improving IVIVCs
Mark Copley
Sampling and analysis of inhalation devices in accordance with ISO 18562
ISO 18562 overview - requirements for respiratory medical devices
Introduction to thermal desorption
Biocompatibility testing using thermal desorption gas chromatography
Dr Nikhil Sahotra
Development of a new moisture-resistant DPI which performs well irrespective of orientation
Moving from concept to a working prototype - challenges and opportunities
Integration of moisture-scavenging technology
Creating a sealed device
Testing challenges
Next steps to a marketed device
Paul Ballington
How can the physicochemical properties of DPIs and their stability impact product performance? A process and delivery perspective
An overview on formulation physicochemical attributes affecting DPI processability and delivery performance
Screening of the distinct overtime solid-state, micromeritics and surface properties of inhalable particles and de-convolution of their impact on product performance
Evaluation of distinct formulation approaches and their potential impact on product performance
Joana Pinto
Spray drying of nanopharmaceuticals into microsphere formulations
Nanoparticles as drug carriers
Safety and efficacy, in vitro and in vivo
Respirable dry powder formulations
Professor Ben Forbes
Programme Day Two
INFORM 2020: new analytical insights into dry powder formulations for inhalation
Structural equivalence for inhaled formulations
Microstructural analytical techniques
Multi-scale computed tomography approaches to look inside formulations
Identifying metrics of relevance to inhaled product performance
Professor Darragh Murnane
Dry powder formulations: from low dosage API delivery to biopharmaceuticals
Drivers for choosing amongst different DPI formulation approaches
Case study on carrier-based DPI formulation development
Case study on spray dried composite DPI formulation development
Capsule filling of challenging DPI powders
Eunice Costa
Inhalation products, transitioning from less to more regulated markets, can it be that difficult?
What is less regulated'?
Combination product regulation and how it impacts inhalation products
Regulatory trends, where are things headed?
The typical GAPs and how to try to close them
Is there an easy route?
Is the transition worth it?
David Howlett
Formal product characterization studies required for DPI's
Why and when these tests are performed
What to include - how to design an appropriate product characterization study
Differences between US and EU requirements
In depth look at the specific tests required (Stability studies, Temperature Cycling, Effect of Patient Use, Effect of Orientation, Drug Deposition on Mouthpiece, Effect of Varying Flow Rate, Device Robustness)
Chris Vernall
Overcoming the need for comparative clinical endpoint bioequivalence studies in a 505(j) ANDA weight of evidence approach for orally inhaled products
Dr Rob Price
The 1nhaler and its two jobs
The functional, emotional and social reasons that there is a growth market for single-dose DPIs
Don Smith
Opportunities and challenges in the design of a high-performance unit-dose DPI
Design opportunities and challenges for a fit for purpose' capsule-based DPI
Prototyping challenges
Preliminary performance data
Anselm Ebert and George Bostock