Tom French

Day 2: Friday, 06 August 2021

CASE STUDY: The impact of filling technology selection for dry powder formulations on device performance, process consistency and commercial scale-up

• Consistent high efficiency aerosoliation performance is a critical quality attribute for all dry powder inhalers. There is a strong dependant relationship between the powder formulation, filling technology, device design and the device performance.
• The desire to deliver a wider range of molecular types of drug has promoted a large increase in the use of engineered particle technologies e.g. spray drying for DPIs which require careful consideration of process conditions.
• Highlight the impact of filling technology on device performance, process efficiency and manufacturing throughput. Could selection of the right filling technologies enable increased formulation and device design spaces.
• Assess the potential issues due to filling technology with process scale-up to achieve continuity of performance as you move from bench, through clinic to commercial; minimising risk in the development process.
• Affirm the importance of early stage filling trials on formulation selection and device design.