The vast majority of new molecular entities discovered today have poor solubility and/or permeability. Neither of these characteristics is beneficial for good bioavailability. This workshop will review the landscape of tools and techniques currently available to formulators, and present case studies to help overcome these challenges, topics including:
- Formulation approaches to bioavailability enhancement
- The use of co-processed excipients to facilitate formulation and processing of bioavailability enhancing technologies
- Technology approaches to bioavailability enhancement including a detailed look at the benefits of nano-particles.
- A review of the landscape of in-vitro analytical tools available to predict bioavailability enhancement, including a detailed look at a novel predictive tool to measure permeability.
About the Speakers
Dr. Janice Cacace currently leads the Product Development group at CoreRx, a CDMO based in Clearwater, FL. Dr. Cacace’s career has spanned over 30 years in the pharmaceutical industry in the areas of formulation, product development, consulting and academia. She has held management level positions involved in pharmaceutical product development for 15 years at various CDMO and pharmaceutical organizations. Her experience covers a wide range of dosage forms and product types including tablets, capsules, spray-dried dispersions, wet and dry granulations, soft gelatin capsules, oral liquids, topicals, injectables and medical foods that cover both generic and new chemical entities. Dr. Cacace holds a Bachelor of Science Degree in Pharmacy from Purdue University and a Ph.D. in Pharmaceutics from the University of Florida.
Mr. Joseph Zeleznik serves as Manager of Technical & Regulatory Affairs with MEGGLE USA. In his role, he is responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Prior to joining MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 20 years experience in the pharmaceutical industry, having specialized in the development and application of high functionality excipients and in particular, co-processing applications for the enhancement of excipient and pharmacologically active ingredient performance. He holds several patents in areas of product and process development, formulation development, and API co-processing. Mr. Zeleznik has authored or co-authored several articles published in various industry journals. He holds a Master’s Degree in Chemistry from the State University of New York.
Dr. Wolfgang Beier is the founder and current CSO at leon-nanodrugs, a proprietary nanotechnology company leveraging it’s Microject Reactor (MJR) platform to help overcome bioavailability challenges via co-development projects with pharmaceutical and biotech companies for current and new molecular entities. Dr. Beier has 35+ years of R&D experience in the international pharmaceutical industry. He has held top executive management R&D positions in various pharma companies and was founder and CEO of PFK Pharma Research, CEO of PFK-ILEX Oncology, and co-founder and CEO of Oncology World, Munich. Dr. Beier holds a Ph.D. in Clinical Pharmacology from the University of Hamburg.
Dr. Konstantin Tsinman is the Chief Scientific Officer at Pion Inc. and has been with the company since 1998, where he originally joined as principal developer of the high throughput permeability analyzer, and subsequently the HT method for measuring solubility – pH profiles. Dr. Tsinman’s current interests include investigating physicochemical factors influencing the absorption of pharma compounds; expanding the scope of applications for in situ UV fiber-optic techniques including real-time concentration monitoring of multi-component systems, and developing in vivo predictive dissolution – absorption methods. He has co-authored more than 25 articles published in primary scientific journals and holds several patents. Dr. Tsinman received his Ph.D. in Physics in 1994 from the Institute for Metal Physics, Kiev, Ukraine.