API in Capsule: A Smart Approach for Rapid Drug Development
Sponsored by: Capsugel
- Rapid Drug Development
- A P I
Date: 14 September
Time: 3PM London/10AM New York
Micro-dosing in Today’s Pharmaceutical Industry
Micro-dosing is the procedure of dispensing precise amounts of drug substance into capsules (powder-in-capsule or PIC). The PIC approach can help on two levels:
1. Speed- it enables a jump start on feasibility and first-in-human studies. Valuable data is obtained to help with the drug substance’s life cycle.
2. Assessment- drug substances’ physical characteristics are ever-changing and becoming more challenging. Flow properties, particle size, hygroscopicity, and particle morphology are obstacles to overcome during formulation development. Parallel studies can be conducted to help understand the nature of the drug substance without losing valuable time during feasibility studies.
Capsugel’s proprietary Xcelodose® Precision Powder Micro-dosing System facilitates the PIC approach by providing accurate, consistent and automated fill across compound types inclusive of very low dose applications. Xcelodose Systems have become the industry standard for micro-dosing with rapid PIC manufacture and fill accuracy to 100 micrograms.
Micro-dosing best practices have been developed by Xcelience, based on the experience of more than 600 batches and 200 compounds, utilizing Xcelodose Systems to reduce product development time by 13-17 weeks.
Team Leader, Preformulation and Formulation Development Services, Xcelience
Mark Cappucci is Team Leader for Preformulation and Formulation Development Services at Xcelience, A Division of Capsugel. Mark and his team are responsible for characterizing the physical and chemical properties of new drug substances. Mark received his B.S. in Chemistry from The Ohio State University and has worked in the pharmaceutical industry for 19 years. Prior to joining Xcelience, Mark worked for Amgen in Thousand Oaks, CA and Bausch & Lomb in Tampa, FL.
Vice President, Operations, Xcelience
Ted Koontz is Vice President of Operations at Xcelience, A Division of Capsugel. Ted manages the manufacturing department. He has over 20 years of industry experience with solid oral dosage forms in the areas of manufacturing, operations, analytical and formulation development. Ted earned a B.S. in Nuclear Engineering/Technology in 1998.
Key Learning Objectives
- Value of API-in-capsule for phase I and II studies
- Key considerations with micro-dosing
- Case studies from different perspectives on usage- potent to low dose applications
- Best practices- experimental and cGMP capabilities—pushing the limits and creative solutions
- Heads of Research and Development
- Heads of Formulation
- Heads of Pre-Clinical
- Heads of Clinical Manufacturing
- Pharmaceutical Scientists
- Pharmaceutical Project Managers