Pharma's Almanac, Global Pharmaceutical Supply Chain Trends, Q3 2016
|Márcio Temtem, PhD - Associate Director, Particle Design and Formulation Development|
|João Vicente, PhD - Team Leader, Particle Engineering and Solubility Enhancement|
In the pharmaceutical industry the production of spray dried powders is still based on the batch concept. The quantities required in the early stages of the development are typically small but may increase by several orders of magnitude as the drug candidate advances through the clinical phases and reaches the market. A spray drying process can scale-up directly from the laboratory to a final production scale, however some quality attributes of the product may change during the scale-up, namely particle size and bulk density. Therefore the need for robust process understanding is essential in order to control and improve powder properties and minimize use of expensive materials during drug development.
The scope of this webinar is to describe some predictive tools and methodologies that can be used to support process/product development and scale-up activities. The development tools and methodologies aim to ensure that product and process development is as straightforward and predictable as possible.
Key Learning objectives
- Fundamental principles of the spray drying process
- Considerations about the different spray drying scales
- Scale-up methodology: From lab to commercial scale
- Development by design initiative