Three Day ‘Team Taught’ Intensive Course for Scientists, Managers and Technicians
Course Background
Pharmaceutical aerosols, (particularly as metered dose inhalers (M.D.I.’s) and dry powder inhalation systems, have over recent years, shown a steady growth in conjunction with nebulisers and nebulisation systems. More recently nasal delivery devices are increasingly being used as novel drug delivery systems. The advantages and disadvantages of all these devices will be compared, with M.D.I’s and dry powder inhalation systems being covered in detail from development through marketing, launch and patient use. The increasing demands of the world’s regulatory authorities in terms of product performance, safety and quality and how this has led to more sophisticated testing procedures together with a rational approach to product evaluation and supporting documentation will be reviewed.
Course Objectives
The purpose of the Course is to provide a sound background in aerosols generally and metered inhalers and dry powder devices, specifically. Since none of these product administration systems can be developed in isolation, a high level of integration is required between product, pack/device so that an adequate performance and shelf life can be achieved by effective testing procedures. This involves a thorough knowledge of formulations and the materials (metal, plastics, rubbers, etc.) from which the pack/device component may be produced. The aim of the Course is to provide information across these diverse areas.
Who Should Attend
The Course is designed to provide a broad knowledge base on aerosols and dry powder devices with limited reference to nebulisers. It is therefore intended for those who require an overview of the technologies involved as well as those who require specialised knowledge of more specific areas, ie. R & D, Development, Production, QA, QC and Regulatory Affairs
The course will cover -
The Challenge Between M.D.I.’s, Dry Powder devices and Nebuliser Systems A review of each system
Common areas between aerosols, dry powder devices etc.
Inhalation Technology, the Role of Particle Size Analysis and Powder Characterisation
A review of methods and equipment, and interpretation of particle size analysis. The properties of powders and the production of powders of the required particle size
Testing and Stability Aspects Standard tests
Non standard tests and stability profiling. Influence of compendial standards and ICH guidelines.
Quality Assurance, Quality Control, Specifications, Validation and Regulatory Requirements
A review of documentation and procedures
Microbiological and Sterile Aspects Evaluating and minimising bioburden
Production and evaluation of sterile products
Dry Powder Inhalation Systems
The testing and evaluation of dry powder inhalation systems: stages and methods of evaluation, clinical and laboratory.
Dry Powder Inhalation Devices
A review of current and development devices, including practical case histories. Powder technology and powder characterisation:
Materials Science Aspects of Dry Powder Inhaler Development
Characterisation and control of the active pharmaceutical ingredient physical properties.
Function, characterization and control of lactose for inhalation. Some particle and formulation strategies for D.P.I.’s.
Inhalation Product Development
Including case studies on DPI and CFC to HFC transition programmes
Development and Manufacturing Issues of Inhaled Products
Future Trends and Technology in Inhalation Aerosol Devices
In-Vivo Testing of Inhaler Devices
An Overview of Nasal Delivery Device Technology
Physiology, formulation approaches, hardware, testing and evaluation.
Regulatory Considerations for Inhaled Delivery Systems
Course Background
Pharmaceutical aerosols, (particularly as metered dose inhalers (M.D.I.’s) and dry powder inhalation systems, have over recent years, shown a steady growth in conjunction with nebulisers and nebulisation systems. More recently nasal delivery devices are increasingly being used as novel drug delivery systems. The advantages and disadvantages of all these devices will be compared, with M.D.I’s and dry powder inhalation systems being covered in detail from development through marketing, launch and patient use. The increasing demands of the world’s regulatory authorities in terms of product performance, safety and quality and how this has led to more sophisticated testing procedures together with a rational approach to product evaluation and supporting documentation will be reviewed.
Course Objectives
The purpose of the Course is to provide a sound background in aerosols generally and metered inhalers and dry powder devices, specifically. Since none of these product administration systems can be developed in isolation, a high level of integration is required between product, pack/device so that an adequate performance and shelf life can be achieved by effective testing procedures. This involves a thorough knowledge of formulations and the materials (metal, plastics, rubbers, etc.) from which the pack/device component may be produced. The aim of the Course is to provide information across these diverse areas.
Who Should Attend
The Course is designed to provide a broad knowledge base on aerosols and dry powder devices with limited reference to nebulisers. It is therefore intended for those who require an overview of the technologies involved as well as those who require specialised knowledge of more specific areas, ie. R & D, Development, Production, QA, QC and Regulatory Affairs
The course will cover -
- Aerosol Introduction Aerosols and aerosol technology
- Formulation of Aerosols
- General formulations and formulations for MDI’s. Challenges for formulating proteins and peptides
- Aerosols, Valves and Containers Understanding valve systems, drawings, properties of materials and functional features
- pMDI Performance, Testing and Issues
- Aerosol Filling, Facilities and Equipment
- A review of methods, equipment, facilities and environmental needs
The Challenge Between M.D.I.’s, Dry Powder devices and Nebuliser Systems A review of each system
Common areas between aerosols, dry powder devices etc.
Inhalation Technology, the Role of Particle Size Analysis and Powder Characterisation
A review of methods and equipment, and interpretation of particle size analysis. The properties of powders and the production of powders of the required particle size
Testing and Stability Aspects Standard tests
Non standard tests and stability profiling. Influence of compendial standards and ICH guidelines.
Quality Assurance, Quality Control, Specifications, Validation and Regulatory Requirements
A review of documentation and procedures
Microbiological and Sterile Aspects Evaluating and minimising bioburden
Production and evaluation of sterile products
Dry Powder Inhalation Systems
The testing and evaluation of dry powder inhalation systems: stages and methods of evaluation, clinical and laboratory.
Dry Powder Inhalation Devices
A review of current and development devices, including practical case histories. Powder technology and powder characterisation:
Materials Science Aspects of Dry Powder Inhaler Development
Characterisation and control of the active pharmaceutical ingredient physical properties.
Function, characterization and control of lactose for inhalation. Some particle and formulation strategies for D.P.I.’s.
Inhalation Product Development
Including case studies on DPI and CFC to HFC transition programmes
Development and Manufacturing Issues of Inhaled Products
Future Trends and Technology in Inhalation Aerosol Devices
In-Vivo Testing of Inhaler Devices
An Overview of Nasal Delivery Device Technology
Physiology, formulation approaches, hardware, testing and evaluation.
Regulatory Considerations for Inhaled Delivery Systems
