Developing and optimizing an in vitro gel-based diffusion assay for subcutaneously administered insulins with the USP apparatus IV
8 February 2024
About speaker
David Li
David is a PhD candidate at the NUS Department of Pharmacy specializing in dissolution studies, focusing on refining USP Apparatus IV flow-through cell methodologies applied for subcutaneously injected formulations. His research is the culmination of his multidisciplinary interests in fields such as 3D model design and physiologically based pharmacokinetic modeling in silico, committed to developing tools for the advancement of future drug development.
He obtained his master’s equivalent after passing the state exams in Pharmacy at the Goethe University Frankfurt. Thereafter he obtained his early training in dissolution studies under Prof Dressman at the Fraunhofer Institute for Translational Medicine and Pharmacology in Frankfurt am Main before embarking on his current journey in Singapore.
Abstract
Over the years, there has been a notable rise in interest in the subcutaneous (SC) administration of drugs, enabling the non-oral delivery of biologics. Challenges in drug absorption and knowledge gaps related to the mechanics inside the SC tissue necessitate a nuanced approach to drug development. Biopredictive performance testing, combining in vitro and in silico methods, offers insights into these release mechanisms post-injection.
This research addresses the lack of standardized in vitro assays for SC drug performance and introduces an innovative in vitro methodology using tissue-like gel matrices inside USP apparatus IV flow-through cells. Using several insulin formulations as model drugs, this setup is used to accurately predict their performance in vivo.