Micronization is an important technique in drug formulation, but not all substances are simple to process. This webinar will give an insight into how micronisation can be developed and scaled up for difficult materials. What technical issues need to be addressed if an API is to be micronized successfully?

After giving an overview of micronisation and common scale-up challenges, the webinar will present a robust process development strategy that ensures all attributes critical for quality are maintained for even the most difficult APIs.

Two case studies will illustrate some of the issues. One is the micronisation of a highly potent API with a tendency to build up on equipment surfaces, and key findings will be presented, including stress testing and solid-state characterization. The second, the micronisation of a fibrous material that was not free-flowing, was successfully scaled up on customized GMP industrial-scale equipment.

Featured Speaker

Salvatore Mercuri

Head of Research and Development

Salvatore Mercuri serves as head of Research and Development at Lonza’s site in Monteggio, Switzerland, which is Lonza’s European Center for Excellence for Particle Engineering, specializing in particle size control through micronization. Salvatore’s expertise includes the development of highly potent active pharmaceutical ingredients (HPAPIs) and the formulation of of modified-release solid oral dosage forms. He joined Micro-Macinazione SA in 2013, prior to its acquisition by Lonza, and has held positions of increasing authority. Salvatore graduated with a degree in Industrial Pharmacy before earning his Ph.D. in Biopharmaceutics and Pharmacokinetics, both from the University of Parma. He completed postdoctoral work in the Department of Pharmacy at the University of Parma, focusing on modified-release dosage forms.

Date:  Thursday, June 24, 2021
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar