Date: May 16, 2018
Location: Egham, United Kingdom
Why, When and How to apply lipid based formulation strategies in early phase drug development
The vast majority of small molecule drug candidates exhibit poor solubility, slow dissolution, and/or low intestinal permeability. Without intervention, these molecular properties can cause lack of efficacy due to poor exposure and increased safety risks (high pharmacokinetic variability, and significant food effects), and are the chief culprits in attrition during clinical trials
Solubility enhancing technologies utilized during the preclinical phase have the potential to generate drug formulations that achieve needed exposure while minimizing drug safety concerns. Among the solubility enhancing technologies available today, lipid based formulation is the most widely studied, best understood, and most commercially viable and utilized technology with the longest track record of commercial success. In addition to enhancing bioavailability, lipid based formulations have been used to mitigate food effects, minimize PK variability, and reduce side effects.
This program will outline a comparative review of currently available technologies for addressing bioavailability challenges, followed by a focus on lipid based formulations, highlighting:
- early phase molecule characterization
- DMPK analysis and formulation decisions for better preclinical and phase I outcomes
- deep dive fit-for-purpose lipid formulation development with expanded applications
- real world case studies
This 1-day program is ideal for drug development scientists and innovators seeking to learn how lipid based formulations can solve their early phase formulation challenges and advance their products to phase I.