CPhI North America took place April 24 - 26, 2018 at the Pennsylvania Convention Center in Philadelphia, PA, and IPEC-Americas was there!
On Wednesday, April 25th, key IPEC-Americas leaders and guests presented a two part session on Excipient Innovation and Its Impact on Drug Development. The session featured: Nigel Langley, Director Technical Service and Scientific Affairs, BASF Pharma Solutions; Joe Zeleznik Manager of Technical Affairs, MEGGLE USA; David Schoneker, Director of Global Regulatory Affairs, Colorcon, Inc. along with Thiago Carvalho Ph.D. Senior Research Investigator in Drug Product Science & Technology, Bristol‐Myers Squibb. Click here to learn more about the sessions.
Title: Excipient Innovation and Its Impact on Drug Development.
Abstract: Excipient innovation is becoming increasingly important as the current available pharmaceutical excipients will not be able to adequately address formulation and manufacturing challenges in drug development in the future. Formulation challenges include the anticipated increase in poorly water soluble, poorly permeable and bitter tasting active pharmaceutical ingredients (APIs) as well as the inherent instability of biologics drug products. Excipient innovation will also be critical in order to improve drug product manufacturing processes such as continuous manufacturing and new technologies such as 3 D printing.
This presentation defined the types of novel excipients and the role of co-processed excipients in drug development. Examples of co-processed excipients were provided, along with their functionality and utility supported by case studies. The current regulatory landscape for the adoption of novel excipients in drug development was reviewed and challenged.
The presentation concluded with a panel session on how the pharmaceutical Industry is aiming to accelerate excipient innovation by engaging with the FDA to define a more appropriate regulatory pathway in the future; a joint initiative by the IQ Pharmaceutical Consortium and IPEC Americas.