Dry Powder Inhalers

Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.

24-25 Jun 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Conference overview

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 in to 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.

This 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.

Media Partners

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RDDEurope2019

New 2019 programme now available!

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 forumulations
  • 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

Media partners and exhibitors

 

Media partners


 

Exhibitors

 

Who should attend

Those involved in

  • Respiratory drug development
  • Inhalation product development
  • Device engineering
  • Formulation development
  • Scientific research
  • Medical marketing
  • Marketing and Business development

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

Book now

24-25 Jun 2020
24-25 Jun 2020 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

Previous customers include...

  • Actelion Pharmaceutical Ltd
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • CELLTECH
  • Coalesce Product Development
  • EPIC THERA/MCKINNEY CONSULTING
  • F. Hoffmann-La Roche Ltd
  • GlaxoWellcome Production
  • Harro Höfliger Verpackungsmaschinen GmbH
  • Insite Technology Limited
  • Intertek
  • Kinneir Dufort Ltd
  • Merck Pharmaceuticals Limited
  • Micron Technologies Ltd
  • Mills & Reeve LLP
  • Mylan Pharma UK Ltd
  • Neutec Inhaler San. Tic. A.S.
  • Novartis Pharmaceuticals UK Ltd
  • Novartis Vaccines & Diagnostics AG
  • PCH Pharmachemie B.V.
  • PDL GROUP
  • Phillips-Medisize
  • Qualicaps Europe SAU
  • Respivert Ltd
  • Revotar Biopharmaceuticals AG
  • Rexam Healthcare La Verpilliere
  • Siegfried Pharma Development GmbH
  • Sortimat Assembly & Feeder Technology
  • Steve Harris Associates
  • Takeda GmbH
  • Tecnimede S.A.

Well selected speakers, covering broad range.

Steffen Fredersdorf, Manager Clinical Program, Philip Morris International

Very good organisation, time keeping, very valuable information delivered by speakers.

Waldemar Wiśniewski, Project Manager, Pulinno sp. z o.o.

Interesting, helpful, nice examples, informative! Offers good overview on DPI's. Many thanks!

Ina Brueckner, CMC Manager Medical Devices, Bayer Pharma AG

Thanks all of them, they share their valuable experience. All of the speakers are valuable people, they are the best in their jobs. Conference met my expectation.

Emre Kisasoz, , Arven

I really thought it as well organised with good content, length of presentations and quality of speakers.

Mahmoud Farag, Scientific Business Development Manager, Qualicaps

Very useful and relevant discussions

David Ward, Senior Formulation Scientist, Intertek

Overall I thought that the course was very useful, mainly due to the networking opportunities. The breadth of attendees was great to get wider conversations underway and broaden understanding. The scientific talks were generally excellent, and although some other talks were more around promoting products / services, the overall impression was positive and useful.

Richard Poole, Team Leader - Pharmaceutical Development, Vectura

In general, the course was very interesting and well organized

Berta Fernández Mollar, Formulation Manager , Ferrer Internacional S. A.

One of the best courses I attended

Anna Giulia Balducci, Senior Scientist, Chiesi Limited

Very good and useful update. Clear messages coming through.

Simon Strothers, Director, 3P Innovation Ltd

The course contained a good mix of speakers, the talks were current and relevant, the speakers responded well to lively discussions and challenges from the delegates. This is a good size meeting with questions freely asked and delegate interaction very high.

Tanya Church, Head of Laboratory, Chiesi Limited

Great environment to stimulate debate! And challenge preconceptions and novel ideas

Richard Turner, Director Global Sales, Presspart Manufacturing Ltd

The course was very well organised, with a good selection of speakers and topics covered. I will certainly recommend future events to my colleagues.

Christopher Vernall, Business Development Director, Intertek Melbourn