Enhancing Drug Performance Through Lipid-Based Formulations for CNS Indication
Summary: A clinical-stage biopharmaceutical company was developing a potent and highly selective inhibitor of Bruton Tyrosine Kinase (BTK) to treat hematologic malignancies with central nervous system (CNS) involvement. This first-in-class molecule was orally administered and able to penetrate the blood-brain barrier representing a significant advancement in disease treatment. To address the challenges of low bioavailability, variability in drug exposure, and Active Pharmaceutical Ingredient (API) instability, the company engaged with Catalent to develop an oral lipid-based formulation that would lead to a more predictable and reliable drug response.