Drug Digest: Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews a panel of experts from IPEC Americas about excipient grades. During the panel session, Nigel Langley, David Schoneker, Kathy Ulman, Priscilla Zawislak, and Joseph Zeleznik go into detail about the various excipient grades and why the use of the correct grade in pharmaceutical products is important; what ‘testing up’ of an excipient grade is and if it is possible to do so for drug products; where the responsibility lies in ensuring the correct grade of excipient is used in the manufacture of a drug product; if it is possible to use non-compendial grade excipients in drugs; excipient grade considerations in academic research; the importance of FRCs in formulation development; and considerations for companies looking to change excipient provider.

For a list of resources associated with this Drug Digest episode, please click HERE.

Interview featuring:

Nigel Langley
Chair, IPEC-Americas
Global Technical Director, Life Sciences, Gaylord Chemical Company LLC

Nigel provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel 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). He also took a two-year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co-edited three books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC-Americas since 2010 and is currently Chair.

David R. Schoneker
Executive Committee Member and QbD/Composition Committee Chair, IPEC-Americas
President/Owner, Black Diamond Regulatory Consulting, LLC

David has over 45 years of experience and has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world.He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements.

Prior to August 2019, David was the Global Regulatory Director—Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019. David was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee, the Chair of the QbD/Composition Committee and is actively involved with the development of Regulatory, Safety, GMP and Supplier Qualification related guidelines to improve Excipient Quality and Safety.

Katherine Ulman
Member/Consultant for IPEC-Americas
Owner and Primary for KLU Consulting, LLC

Katherine retired from Dow Corning Corporation after more than 40 years of employment. While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. In addition to her regulatory role, she was an associate scientist at Dow Corning where she worked in the development and characterization of pharmaceutical excipient and medical device raw materials/components. Much of her early career was dedicated to the synthesis of novel silicone monomers and polymers/copolymers. Katherine has been a member of the ACS, AAPS, and CRS. She is currently an active member and support staff for IPEC-Americas. She has published and presented several papers in her field, developed and taught a college course in Organosilicone Polymer Chemistry and Technology through SDSM&T, and taught international courses on silicones for pharmaceutical/biomedical applications and medical adhesives through Technomic Publishing Co. Katherine earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology in 1976.

Joseph Zeleznik
Chair-Elect, IPEC-Americas
Technical Director, North America IMCD

Joseph has responsibility for product and technology training, conducting customer seminars, and advising with formulation development through excipient and process selection. Joe also collaborates with formulation prototype development, demonstrating IMCD’s product and technology benefits. Joe works closely with IMCD’s many principals to promote product awareness and coordinates joint meetings in those efforts. Joe has contributed to the development of several IPEC Guides and is a member of IPEC-Americas’ Executive Committee, serving as chair for the 2024-2025 term. Prior to joining IMCD US, Joe served as Manager, Technical and Regulatory Affairs with MEGGLE USA, Inc. and Associate Director, R&D with JRS PHARMA.

With a career spanning four decades, his interests are varied and include high-functionality excipient development and application, focusing on CPEs and other novel excipients, powder blending strategies, continuous manufacture, and advancing excipient knowledge.

Priscilla Zawislak
President, IPEC Federation
Vice Chair, Science and Regulatory Policy, IPEC-Americas
Global Regulatory Affairs Advocacy Manager, IFF

Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. Currently with IFF, she is responsible for regulatory advocacy for excipients, APIs, and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Specialty Ingredients’ Pharmaceutical and Nutrition business and Quality Manager at FMC Health and Nutrition.

Priscilla is currently President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, China, Japan, and India. She is also the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization. She has been an active member of IPEC-Americas committees since 2001, is a member of the IPEC Americas Executive Committee and a member of the Board of Directors of EXCiPACT.

Priscilla earned her degrees in Biological Sciences and Chemistry from the University of Delaware.

Sponsors:

This episode of Drug Digest is sponsored by:

• Adare Pharma Solutions
• Catalent
• Captisol (Ligand)
• Coating Place Inc.
• Veltek Associates Inc.

About Drug Digest

Drug Digest is a tech talk video series with the Pharmaceutical Technology editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Upcoming episodes

• February 2024: Data Integrity
• March 2024: Hot Melt Extrusion
• April 2024: Stability Testing