Controlled release technologies have long been utilized as a method to enhance drug delivery and to maximize drug efficiency.  API physicochemical and biopharmaceutic properties play a role in determining if the molecule is suitable for controlled release dosage forms. In this webinar, experts will share how dissolution tools and PBPK modeling can help evaluate whether a molecule is suitable for controlled release applications and predict the effects of release rate on in vitro performance.  In addition, the experts will cover all aspects of oral controlled release technologies and discuss current strategies to select the optimal technology to meet the intended release profile.

Key Takeaways:

  • Overview of oral controlled release systems based on release mechanism and the latest insights into the development of in vivo predictive dissolution tools to establish in vitro–in vivo correlation (IVIVC)
  • Development of the Gastrointestinal Simulator (GIS) to study drug release profiles of dosage forms and its extrapolation to non-disintegrating controlled release systems
  • Key PK parameters needed for PBPK modelling of controlled release dosage forms and how to apply PBPK modelling to predict in vitro release profile needs
  • Review of the selection criteria for controlled-release oral solid dosage forms and understanding of how a single-unit versus multiparticulate modified release systems modulate the release profile of the API

Featured Speakers

Prof. Dr. Marival Bermejo

Professor of Pharmaceutics
Universidad Miguel Hernández de Elche

Marival Bermejo is currently a Full Professor at the University Miguel Hernández of Elche-Alicante (Spain). She earned her PharmD and Ph.D degrees at the University of Valencia under the supervision of Prof. Plá-Delfina with a grant from Spanish Government. She was the Assistant Professor in 1993 and was promoted to Associate Professor in 1998 at the University of Valencia. In 2008, she was appointed at University Miguel Hernández to coordinate the Area of Pharmacy and Pharmaceutical Technology in the Department of Engineering. She completed two post-doctoral fellowships at the Institute of Topology and System Dynamics in Paris VII University, collaborating with Prof. Christiane Mercier and at the University of Michigan, working with Prof. Gordon Amidon. She has been awarded with a Fulbright scholarship for a 4-month sabbatical period at the University of Michigan in 2015 with Prof. Gordon Amidon as the local host. From 2016 to 2019 she has been a visiting scientist in summer periods at Amidon’s Lab working on in vivo predictive dissolution methods.

Prof. Bermejo research expertise evolves around intestinal drug absorption, membrane transport and drug product predictive dissolution. She is the co-author of more than 150 papers, 13 books chapters and is co-author with Prof. Gordon Amidon of the English and Spanish versions of Modern Biopharmaceutics, a CD-Rom teaching tool. She is member of the Board of Directors of the Drug Delivery Foundation (www.ddfint.org) and external assessor of the Spanish Agency of Medicines (AEMPS) and EMA (European Medicines Agency).

Ron Vladyka, PhD

Director, Scientific Services, Manufacturing
Catalent

Ron Vladyka RPh. currently holds the position of Director, Scientific Services, FR&D at the Catalent Somerset, NJ site.  He previously held the position of Director, Product Development for the last eight years and has been with Catalent for the last 14 years. During this time Ron has held various positions within Somerset’s Oral and Specialty Delivery formulation and process development teams. His professional career spans over 30 years in various research, product development and drug delivery positions including roles at Aegerion Pharmaceuticals, FMC BioPolymers and Roche. Some areas of interest include development of enabling drug delivery technologies and design of modified release dosage units. Ron received his B.S. degree in biology from Lebanon Valley College and B.S. in Pharmacy from Arnold and Marie Schwartz College of Pharmacy, Long Island University.

Jan Neelissen, PhD

Scientific Adviser
Catalent

Jan Neelissen, Scientific Advisor, has 20 years of industry experience in the field of DMPK, of which 17 years at AstraZeneca holding positions as Associate Principle Scientist delivering 7 clinical drug candidates, Associate Director in vitro DMPK, and Associate Director Modeling and Simulation.  Dr. Neelissen is a biologist by training and received his doctoral degree from the University of Leiden, Netherlands.

Date:  Monday, June 14, 2021
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar