This interactive course will provide a comprehensive overview of metered-dose inhaler technology past, present and future, giving participants a valuable insight into market potential and recent industry trends. The programme will clarify the therapeutic targets and look at the various delivery technologies available. There will be detailed coverage of the current environmental, regulatory and economic pressures and how these impact, development, manufacturing process, equipment and options, together with quality and inspection requirements, human factors and bioequivalence. Our highly experienced trainer will address the regulations applying to inhalation products and provide guidance on the regulatory pathways to follow.
The event will benefit those new to this area and will also be of value to anybody who requires a refresher on the opportunities available with this technology. The seminar format will include practical workshops, which past delegates have found invaluable, and ample opportunity for discussion on any specific issues with an expert in this field.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
Therapeutic targets
- A brief history of inhalation and MDI therapy
- The lung as a target
- Respiratory diseases
- Systemic delivery
- Therapeutic considerations
- Life limiting Vs Life threatening
Markets past, present and future
- Geographic - Challenges and opportunities
- Disease prevalence
- Economic considerations
- International demand
- Modelling opportunity (what to consider)
MDI Technology
- How and Why MDIs work
- MDI Formulation approaches
- The elements of an MDI
- Key performance characteristics
- MDI Feature/ Functions compared to other dosage forms
- Add-On technologies for MDIs
- Are there limits to MDI technology?
Workshop I
- Ranking of competitive technologies for different opportunities
MDI Manufacture
- Key Process steps (space, services, staff)
- Environment (Controls)
- Equipment (Scale, design, options etc.)
- Process controls & Inspection
- Safety and Quality
- Quality by Design (QbD) approaches
- Manufacturing and cost
Day 2
MDI Testing
- What and when to test
- How to test
- How not to test
- Demonstrating equivalence
Regulation of MDIs
- Legislation
- Regulatory guidance
- Consensus standards
- Pharmacopoeial requirements
Developing an MDI
- The MDI as a drug-device combination product
- Applying Design Controls
- Human Factors & Usability
- Risk management
Workshop II
- SWOT MDI vs multi-dose DPI
- SWOT MDI vs soft mist inhaler
MDIs and the environment
- Inhaler Carbon Footprint
- Environmental pressures on MDIs
- Alternate propellants (Alternate problems?)
- Alternate design approaches
- Recycling - Technical and patient considerations
The future of the MDI
- Summary of the Course
- What opportunities does the future hold?
- Workshop
Speakers
Mr David Howlett,
Director ,
PharmaDelivery Solutions LtdDavid Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs).
PharmaDelivery Solutions Ltd has provided key programme inputs in various forms including due diligence, regulatory GAP Analysis, strategic and detailed planning, implementation, mentoring and training.
In addition to activities supporting commercial organizations, has been involved in the following roles;
Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms
A UK national expert representing the British Standards Institute developing international standard ISO 20072:2009 for pulmonary and nasal delivery, and a committee member on other standards committees
Worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol
An invited speaker at a number of international meetings and symposia on device development related subjects, including regulatory expectation, DPI development, extractables and leachables control and emerging markets
Who Should Attend
- Respiratory pharma professionals who need to understand MDI technology and its opportunities
- Medical device professionals new to working in the area of MDIs or those who need a refresher
- Development and regulatory professionals, with a development or product portfolio including MDIs, who need an understanding of future demands
- Medical device business development managers
- Respiratory professionals in R&D
- Medical device manufacturers working in the respiratory market
