Fast-Track Clinical Transition from Lipid-based Solution to Lipid-based Suspension in Softgels
Summary: A clinical-stage biotech focused on neurology faced challenges with a lipophilic, oxidation-sensitive molecule limited by solubility, stability, and scalability. Their initial liquid-filled hard capsule (LFHC) could not exceed 100 mg per dose and suffered from short shelf life and manufacturing issues. Partnering with Catalent, the company transitioned to a lipid-based suspension softgel using long-chain triglycerides (LCT). This innovative approach improved solubility, stability, and bioavailability, raised drug load from 20% to 45%, and reduced pill burden. Catalent delivered a clinic-ready formulation in just 4 months, enabling faster trials and better patient outcomes.