An increasing number of new molecules in pipelines are poorly soluble, and more than ever applying a bioavailability enhancing technology early to enable exposure and efficacy is a key factor to success.
Amorphous dispersion development is a growing approach to improving the bioavailability of poorly soluble compounds. Spray drying is an established and growing technology for preparing amorphous dispersions. This webinar introduces key spray dried dispersion development considerations to allow for identification of a stable prototype that will enhance and sustain in-vivo drug solubility. Discussions will include spray dried dispersionformulation development and early phase considerations for finished dose development.
- Parameters that indicate amorphous spray dried dispersions are an optimal formulation approach
- Pre-formulation studies to ensure successful development of spray dried dispersions
- Best practices for formulation screening and evaluation of stability, performance, and manufacturability of spray dried dispersions
- Preformulation solvent solubility screening and stability assessment
- Rapid polymer screening for solubility enhancement
- Screening of selected polymers and drug loads for physical and chemical stability
- Excipient compatibility testing
- In-vitro and in-vivo formulation screening
- Critical quality attributes & keys to successful spray drying
- Early phase finished dose formulation strategies for spray dried dispersions
Stephie Lee, Associate Scientist, Catalent
Stephie Lee, M.S., is an Associate Scientist at Catalent in San Diego. She has a broad background in preclinical and clinical formulation, process development and GMP manufacturing of small molecule candidates, with a focus on early phase strategies for bioavailability enhancement of poorly soluble compounds. Stephie has managed more than 60 oral formulation programs, including spray dried dispersion, fluid bed processing, and micronization projects. Prior to joining Catalent, Stephie was a researcher in Dr. Richard Kaner’s laboratory at University of California, Los Angeles (UCLA), where she focused her research on the effects of various reaction conditions on the morphologies of nano conductive polymers such as polyaniline, polypyrrole and the fabrication of free-standing thin films of these materials. She received her Masters of Science in Chemistry and her Bachelor of Science in Biochemistry from UCLA.
Eric Gorman, Research Scientist II, Gilead Sciences
Eric Gorman, PhD, is a Research Scientist II at Gilead Sciences in Foster City, CA. He has experience with formulation and process development for a wide range of development stages including: preclinical/discovery, first-in-human, late stage clinical, and product commercialization. He has worked on several spray-dried dispersions, including down-stream processing into oral products, and has had responsibility for formulation selection, process development, GMP manufacturing, and CMC components of regulatory submissions for these projects. Eric has been at Gilead for six years, and prior to joining Gilead he was a graduate student in Dr. Eric Munson’s lab at the University of Kansas, Department of Pharmaceutical Chemistry. His MS and PhD work at the University of Kansas was focused on the characterization and quantification of crystalline and amorphous forms of pharmaceuticals, with a particular focus on the use of solid-state NMR. He also received a Bachelor of Science in Pharmaceutical Sciences from Drake University.
Who Should Attend?
- Director / VP Drug Development, CMC, Manufacturing, Analytical Development, Formulations or Formulation Development
- Director / VP Quality Assurance and Regulatory
- Technical Product Managers
- Principal Analytical Chemists
- Team Leaders
- Formulation Development Scientists
- Consultants for Drug Development, CMC, QA
Catalent is the #1 industry partner for advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise and the broadest portfolio of advanced technologies to bring more customer products to market faster, enhance product performance and ensure reliable clinical and commercial product supply. Our team of over 10,000 people, located at over 30 sites on five continents, produces +70 billion doses of +7,000 products for more than 1,000 customers from 87 of the top 100 global pharmaceutical marketers, to 24 of 25 biological marketers, to 21 of 25 leading consumer health marketers, to thousands of small innovators globally. Our passion is to help unlock the full potential of your product.