Summary: Lipid-based formulation (LBF) can potentially improve the oral bioavailability of challenging molecules. However, when planning for solubility and bioavailability enhancement of poorly soluble drugs, LBF is often overlooked due to a generally poor understanding of LBF technology and the prevalence of preconceived notions about its complexity, especially when transitioning formulations from preclinical toxicology to clinical studies. In this webinar, experts offer insights into the perceived barriers to developing LBFs and recent advances in translating them into useful clinical and commercial products of lipophilic drugs. Experts will also discuss lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile. In addition, the experts discuss the preformulation considerations of LBF development and the use of PBPK modeling to yield key insights into oral bioavailability. Finally, experts share approaches from an industrial standpoint on how to transition LBFs from preclinical toxicology to a viable formulation suitable for an accelerated pathway in the clinic.
Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-based Formulations