ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
The landscape for oral drug delivery is rapidly evolving as the molecules to be delivered become increasingly more complex. The time when the rule of five governed the perspective on effective oral delivery has long passed, and we are regularly tasked with developing oral products for low solubility and low permeability small molecules, PROTACs, peptides and other challenging moieties. While technology selection for bioavailability enhancing enabled formulations often emphasizes design and development of an enabled intermediate, the increasing complexity of the molecular landscape necessitates a more comprehensive approach that considers the drug product design and manufacturability simultaneously with intermediate development. This is especially relevant as clinical development timelines compress and advanceable and robust formulations are needed right from the start of development.
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products. Among the examples highlighted are the development of enabled tablet formulations designed as an alternative to amorphous dispersions, product design for amorphous dispersions when alternative technologies fail to provide sufficient enablement, and considerations on the product and process design for oral solid dosage forms containing permeation enhancers.
Key Takeaways
• The “rule of five” (ByRo5) is no longer sufficient as drug developers frequently encounter molecules with low solubility and permeability, driving them toward new and innovative formulation strategies
• A strategic vision for drug product design combined with an understanding of molecular properties can lead to successful formulation development, even for challenging compounds
• Formulation development should not solely focus on enabling intermediates. Product design and manufacturability must be considered in conjunction with intermediate development.
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About the author:
The author is a Principal Scientist in the Process and Product Development department at Serán. He leads a team of scientists and engineers in investigating new drug substances and identifying shortcomings for oral bioavailability.
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