Bringing complex oral drugs to the clinic requires overcoming significant solubility, permeability, and bioavailability challenges. Many early-phase programs stall due to limited API supply, formulation setbacks, or unpredictable pharmacokinetics that delay IND timelines and increase development risk.
Lipid-based formulations (LBFs) and softgel technologies offer a proven solution for these challenges, enabling oral delivery success across all BCS classes. By enhancing solubility in BCS II and IV drugs, improving permeability in BCS III compounds, and protecting sensitive BCS I actives, lipid-based systems provide unmatched versatility and clinical readiness.
This webinar will explore how to strategically apply lipid-based formulation platforms, including solutions, suspensions, self-emulsifying drug delivery systems (SEDDS), and their microemulsifying counterparts (SMEDDS), to meet diverse molecule needs. Attendees will learn how early softgel integration supports formulation flexibility, addresses API-limited scenarios, reduces variability, and accelerates development. Real-world case studies will highlight formulation design, early-phase dosing strategies, and scale-up approaches that connect technical execution to clinical and commercial impact.
Key Learning Objectives
- Discover how softgels reduce development timelines and variability in early-phase trials
- Explore solutions for common challenges like low API supply, oxidative sensitivity, suspension dosing, and scale-up
- Explore real-world examples of softgel-enabled lipid formulations advancing early-phase programs across diverse BCS classes and global development settings