This webinar explores the rationale for dosage form design of lipid-based formulations to ensure successful project delivery.
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. To avoid development challenges and delays, it is critical to fully explore these parameters by the most appropriate means when developing formulations to enhance and maximize oral bioavailability.
Lipid-based drug delivery systems offer a way to effectively deliver poorly soluble or bioavailable drugs in both preclinical and human studies. It is the physicochemical characteristics of the API which 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 delivery formulation is complex. Once a formulation has been established in preclinical studies and is proven for effective administration, translation to lipid-based drug formulation first-in-human studies require further consideration and can pose further 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 are translated to human studies, it is essential to consider the requirements of a target product profile, with particular focus on aiding patient compliance.
During this webinar, we will also share examples for how to approach product design and scale up for various dosage forms. We will also look at case studies to show the various project stages and duration of activities associated with developing successful formulations for FIH studies.