Implants and Depots – How To meet Challenges in Polymeric Controlled Release with Bioresorbable and Biodurable Materials
Technology Forum Presented By: Lubrizol LifeSciences/Corbion
Date/Time: Sunday, July 21, 2019 - 8:00 AM to 10:15 AM
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- Andrew Loxley, PhD, International Formulation Development Consultant, USA
- John Garner, PhD, General Manager PolySciTech Division, Akina Inc, USA
- Professor. Dr. Ir. W.E. Hennink, Head of Department of Science, Pharmaceutical Sciences and Pharmaceutics at Utrecht University, The Netherlands
Polymeric implants and depot injections offer advantages over traditional dosage forms, including localized, targeted delivery, lower dosage requirements, and greater patient compliance. However, developing these complex drug products is not a straightforward task. In this seminar, we will explore solutions to the common challenges that arise in polymer selection and formulation development from the perspective of both trusted polymer supplier and seasoned contract development and manufacturing organization. We will provide an overview of the benefits of polymeric delivery using both bioresorbable and non-bioresorbable polymers, review devices and depots in the market, the manufacturing techniques, case studies and regulatory challenges.
John Garner, Manager, Akina, Inc., received his Bachelors of Science (Major Chemistry/Minor Biology) degree from University of Indianapolis in 2005. Since that time he has worked with Akina, Inc. on a wide range of projects in the biomedical device, controlled release, and biodegradable polymer fields. He has authored ten scientific articles, twelve scientific poster presentations, three book chapters, and three patent applications. Akina, Inc. provides over 650 research-polymer products through the PolySciTech division (www.polyscitech.com) which have resulted in more than 350 research publications. Through the Akinalytics division, Akina, Inc. provides sample analysis and contracted research options within the biomedical/pharmaceutical fields.
"Complex Sameness: Tests to Determine Properties for PLGA Excipients in Long-Acting Formulations" (Presentation)
The properties of the Poly(lactide-co-glycolide) (PLGA) excipient in the proposed generic of long-acting injectables (LAI) must match those of the reference formulation to ensure bioequivalency for regulatory approval. A lack of understanding regarding the characterization of PLGA is delaying generic formulation progress despite several patent expirations. For the past few years, Akina, Inc. has worked with the Food and Drug Administration, Office of Generic Drugs towards developing characterization methodologies for PLGA in LAI. The presentation covers several aspects of PLGA characterization including extraction methods, branching, LA:GA ratio, molecular weight, chirality, blockiness, and separating complex mixtures of PLGA of varying types.
Disclaimer: The content of this presentation does not necessarily represent the official views of the Food and Drug Administration.
Wim E. Hennink
Professor and head of the department of Pharmaceutical Sciences, Utrecht University
Wim Hennink obtained his Ph.D. degree in 1985 at the Twente University of Technology on a thesis with a biomaterials research topic. From 1985 until 1992 he had different positions in the industry. In 1992 he was appointed as professor at the Faculty of Pharmacy of the University of Utrecht. From 1996 on he is head of the Pharmaceutics division. At present he is the head of the Department of Pharmaceutical Sciences, Utrecht University. His main research interests are in the field of polymeric drug delivery systems. He published over 520 papers and book chapters and is the inventor of 20 patents.
Dr. Loxley is a consultant with 25 years’ experience in the technology and business of nanomaterials and products based on them. Dr. Loxley has held senior positions at several companies and has contributed to the development of several successful nanotechnology-based products. He has focused his career within start-up companies, helping to create value leading to exits totaling more than $1.5 BN. At Particle Sciences, part of Lubrizol Life Science, Dr. Loxley led the development of many novel formulations based on liposomes, lipid and polymer nano and microparticles, bioresorbable and biodegradable polymers, and drug-eluting devices, using techniques including nanomilling, microfluidization, spray drying, melt-chill, hot-melt extrusion and injection molding. Dr. Loxley has authored several articles, contributed to numerous books on nano-formulations and drug-eluting devices, and holds over 40 patents.
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