Business and Technical Consultant Evolve Consulting Barcelona, Catalonia, Spain
The overwhelming majority of new chemical entities continue to face the hurdle of poor solubility, which in turn leads to challenges in bioavailability and, ultimately, therapeutic efficacy. This presentation advocates for a strategic and informed approach to formulation development, urging a move "beyond the first choice" and a deeper consideration of lipid-based formulations (LBFs) as a powerful tool to overcome these solubility-related challenges.
The talk begins by highlighting the prevalence of poorly soluble compounds and the limitations of conventional formulation approaches. It emphasizes the importance of carefully selecting among an increasing choice of enabling technologies, with a particular focus on the unique advantages offered by LBFs. By delving into the science behind lipid-based drug delivery, the presentation explores how these formulations can enhance drug solubilization, interact favorably with physiological processes within the body, and ultimately improve drug absorption and overall product performance.
Furthermore, the presentation showcases the value of in vitro testing as a predictive tool, as originally inspired by the Lipid Formulation Classification System (LFCS) and later empowered by the LFCS Consortium, in guiding the development and optimization of LBFs. Real-world examples, including the evolution of cyclosporine formulations (Sandimmune® to Neoral®) by formulation optimization, and the re-formulation of abiraterone acetate (the active ingredient in Zytiga®) from a tablet to an LBF, are used to illustrate the tangible benefits of LBFs, such as improved bioavailability, reduced food effects and overall variability. The presentation concludes by reinforcing the idea that LBFs represent a versatile drug delivery platform with the potential to unlock enhanced drug performance, cater to diverse patient populations, and create opportunities for innovative product lifecycle management. It encourages a shift in mindset towards a more strategic and scientifically driven approach to formulation development, where LBFs are recognized as a key enabler for overcoming solubility challenges and maximizing the therapeutic potential of drug candidates.
Learning Objectives:
Upon completion, participants will benefit from a comprehensive view on the benefits of lipid based formulations as powerful tools to increase solubilization and enhance bioavailability, reduce food effects and variability
Upon completion, participants will have a clear picture on the space in which LBFs work best, as evidenced by IVIVC and real-life case studies
Upon completion, participants will gain a more objective view on technology selection, and how formulation optimisation or reformulation through LBFs can be a valuable lifecycle management strategy
