DUBLIN--(BUSINESS WIRE)--The "Dry Powder Inhalers - Key Annual Conference for Pharmaceutical and Medical Device Professionals in the DPI Market" conference has been added to ResearchAndMarkets.com's offering.
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
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Advanced manufacturing technology
Dr David Wyatt
Novel DPI delivery platforms
- Marketed DPI platforms
- Novel DPI platforms
- Capability gaps
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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
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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
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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
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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
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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
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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
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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
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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
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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?
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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
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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
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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
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Preliminary performance data
Anselm Ebert and George Bostock
For more information about this conference visit https://www.researchandmarkets.com/r/dhp6tg
