Traditionally, formulation and process development within the pharmaceutical industry is driven by extensive trial-and-error experimentation. The Digital Design of Drug Product (D3P) project integrates qualitative and quantitative tools to facilitate an approach to formulation and process design based on the development of fundamental process and product understanding. A global system analysis approach has been used to realise an in-silico ‘design space explorer.’ This tool is applied to a roller compaction tablet manufacturing process to understand the impact of raw material and process changes on product quality. The approach can be used to inform risk assessment and to design a robust control strategy for the product.
- Introduction and D3P project overview
- Case study - Application of GSA to a Tablet Manufacturing Process
- 'Virtual Experiment Design'
- Raw material variability
- Risk assessing a change in excipient grade
|Gavin Reynolds is a Principal Scientist in Process Engineering, based within Pharmaceutical Technology and Development at AstraZeneca, Macclesfield. He is also a Visiting Professor in the Department of Chemical and Biological Engineering at the University of Sheffield.|