API in Capsule: A Smart Approach for Rapid Drug Development

September 29, 2016

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. 

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

Presented by:

  • Mark Cappucci, Team Leader, Preformulation and Formulation Development Services, Xcelience
  • Ted Koontz, Vice President, Operations, Xcelience

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