This presentation will highlight emerging formulation strategies designed to address solubility, stability, and bioavailability challenges in modern drug development. Recent FDA-approved Captisol®-enabled products will be discussed. In addition, the newly developed FAST (Feasibility Assessment/Solubility Testing) Program will be introduced as an efficient approach to rapidly evaluate excipient compatibility and streamline early-stage formulation decision-making.
The primary focus of the presentation will be the TOPAZ™ formulation platform, a novel approach that leverages low-water systems to create versatile and customizable formulations. By enabling a wide range of compositional space, TOPAZ supports the formation of diverse mixtures that can improve drug solubility, enhance stability, and expand options for multiple routes of administration, including oral and topical delivery.
Case examples will demonstrate the platform’s ability to address challenging molecules, including improved solubility and taste-masking for compounds such as berberine, as well as increased bioavailability observed in preclinical studies.
Together, these approaches illustrate a cohesive framework for accelerating formulation development, reducing development risk, and expanding the range of drug candidates that can be successfully translated into commercially viable products.
Lian Rajewski, Senior Director Formulation Development, Ligand Pharmaceuticals (CyDex Pharmaceuticals)