Meeting the Needs of Formulation Development with Novel Excipients - Nigel A. Langley, Ph.D. (BASF Corp)
Nigel A Langley, Ph.D. (BASF Corp)
Formulation challenges have increased over the last 10 years as more complex drug candidate molecules have been discovered. It is estimated that between 70-90 % of new active pharmaceutical ingredients (APIs) are poorly water soluble with a significant portion also being poorly permeable. Another trend has seen an increase in bitter APIs where taste- masking is needed for patient compliance, especially in the case of pediatric and geriatric patients.
This presentation will explore the ability of novel excipients in helping to meet the formulation challenges presented by APIs with poor solubility and bitter taste. Examples of novel excipients will be given and the utility of Soluplus® and Kollicoat Smartseal® highlighted.
The current regulatory landscape for the adoption of novel excipients in drug development will be reviewed and challenged. The presentation will conclude by providing an update 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.
Date and Location
Thurs Dec 7th, 2017
Registration: 5:30 PM
IMCD US Pharma
About the speaker
Nigel Langley, Director Global Technical Marketing and Technical Service – BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. Prior to joining BASF, Dr. Langley worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and Pharmaceutical excipients. He has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (Liquid Crystals) from the University of Hull, (UK) and an MBA from Leeds University (UK). Nigel has been a member of the Executive Committee at IPEC Americas since 2010 and is currently VC membership. He is also helping to lead the Novel excipient initiative in collaboration with the IQ Pharma Consortium. Nigel is also active in the BioPhorum Operations Group (BPOG) and has 30 years’ experience within the Pharmaceutical excipient industry.
Registered and paid online: $50.00
Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
Advance registration will end at 5:00 PM on TUESDAY DEC 5th; after that, you must pay at the door. Note also that if you choose the "Register Now and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.