2023 - Lipid-Based Drug Delivery: Dosage Form Design from Preclinical to First-in-Human

A high proportion of new drug candidates never reach market due to poor solubility, which limits their potential for absorption. As such, the solubility and permeability of an active pharmaceutical ingredient (API) are the driving forces behind bioavailability. In order to avoid development challenges and delays, it is critical to fully explore these parameters when developing formulations to enhance and maximise oral bioavailability. Lipid-based drug delivery systems offer a way to effectively deliver poorly soluble or bioavailable drugs in both preclinical and human studies. The physicochemical characteristics of the API determine if lipid delivery is an appropriate approach for dosage form design.
Understanding how lipid molecules are classified, in what circumstances they can be utilized and how to design an effective lipid-based drug delivery formulation is complex. Once a formulation has been established in preclinical studies and is proven for effective administration, translation to a lipid-based drug formulation first-in-human (FIH) studies requires further consideration and can pose new challenges.
This webinar will cover the rationale for dosage form design of lipid-based formulations to ensure successful project delivery, including:
Considerations for why lipid approaches are successful and appropriate for assessment
The theoretical basis for classification of lipid-based systems
Design and characterisation of lipid-based systems
Associated analytics required to ensure product robustness and clinical safety
Examples of challenges associated with API recovery from complex matrices
As products translate to human studies, it is essential to consider the requirements of a target product profile, with particular focus on aiding patient compliance. The featured speakers will share examples on approaching product design and scale up for various dosage forms and case studies to show the various project stages and duration of activities associated with developing successful formulations for FIH studies.
Register to learn about improving dosage form design in lipid-based drug delivery systems, from preclinical to first-in-human studies.