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.

• 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

Media partners

Exhibitors

Those involved in

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

A personalised medicine approach to the design of dry powder inhalers

• Summary of inter-patient performance issues for dry powder inhalers
• Proposing a physiological approach to DPI design to address inter-patient variability
• Strategies for computational DPI design optimization achieving personalization of inhaled therapy
• Evidence to validate a CFD-guided DPI design approach
  Professor Darragh Murnane

Novel DPI Delivery Platforms

• Marketed DPI platforms
• Novel DPI Platforms
• Capability gaps
• Value in the eyes of the customer
  Paul Johnson

Experiments with Dry Powder Inhalers

• Findings and results
  David Harris

In-vivo extra fine particles

• Introduction to extra ne particles
• History and current research
• Product design and inhalation pro le
• Future opportunities
  Dr David Lewis

High dose delivery utilising a DPI

• Formulation strategy for high drug content powders
• Selection of appropriate adjuvants
• Multiple inhalation act device for dose release
  Dr Francesca Buttini

The iSPERSETM platform

• Inhaled Dry-Powder iSPERSETM formulation of Itraconazole
• The treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with Asthma
• Clinical trial of Pulmazole
  David Hava (invited)

The next generation combinations

• Selecting triple and quadruple API combinations
• New requirements on the device
• Formulation challenges
  Dr Orest Lastow

Connected DPI devices

• Unmet needs
• Device strategies for connectivity
• Learnings from non-drug connected devices
• Hurdles:
  • Devices and services – Evidence
  • Data infrastructure
  • Business models
• Future directions
  Tom Oakely

New medical device and combination product regulations on DPI development

• Overview – The guiding documents and principles
• Medicinal product – delivery device – container closure – combination products, where do DPIs fit?
• International Standards Vs National Regulation – Which takes precedence?
• Medical Devices Regulation vs Quality Systems Regulation (the destination vs the journey)
• Acronyms and jargon (DHF, DHR, DMR, DMF, Technical les) what do they really mean?
• How much time (and cost?) will it add to my DPI programme?
• Retrospective/ late stage application of controls, can it work?
• Developing a global strategy – is it possible?
  David Howlett

Human factors in the design of DPIs

• Usability and human factors engineering – what is required?
• User centred design
• Considerations and learnings from experience
  Greg Thay

Challenges with generics

• Establishing robust analytical methods to test the Critical Quality Attributes (CQA’s) of both test and reference product
• Using current regulatory guidance to design an appropriate IV-BE study
• Bridging the gap to IV-IVC (including the use of realistic breathing pro les and lung dissolution models)
  Chris Vernall

Bioequivalence research with the FDA

• What are the FDA looking for?
• Research and ndings
• Experience and opportunities
  Dr Jag Shur

Dissolution and beyond: the use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products

• Achieving Q3 structural equivalence in dry powder inhalers
• Integrated measurement of structure through dissolution
• Understanding the state of agglomeration through advanced analytical techniques
  Professor Robert Price

Get it right: 100% in-line verification of dosed mass in inhalation devices

The current good manufacturing practices (cGMP) requirements become more demanding and statistical in-process control (IPC) as well as process analytical technology (PAT), these are key components of quality control in a pharmaceutical manufacturing environment. The lling of powder for inhalation into blister or other receptacles for pre-metered powder is a challenge due to low ll weight and poor powder ow-ability. New technologies are utilizing different control systems to ensure consistent quality of the products and to reduce waste & overall costs.

• A machine manufacturer’s view on PAT
• Options to satisfy continuously increasing manufacturing requirements
• The issues of current inhalation blister ll weight control (destructive in-process control)
• Actual developments to integrate non-destructive 100% in-line veri cation systems of filled mass in inhalation blisters
  Dr Karlheinz Seyfang

Developing inhaled Lactose formulations
Dr Paul Royall

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.