This presentation explores the development of extended release subcutaneous thermo-responsive in situ gel forming delivery systems using commercially available polymers. This work employs a Design of Experiment (DoE) approach to explore first, the relationship between copolymer composition, concentration, and gelation temperature (GT), and second, to identify the optimal copolymer composition and drug loading in the thermo-responsive formulation. Furthermore, this work addresses the disconnect observed between in-vitro drug release and in vivo pharmacokinetic (PK) profiles. The results demonstrate the importance of investigating the impact of drug’s physicochemical properties and drug loading on the LCGT of thermogel formulations for small molecules during formulation development. The DoE strategy used in this study might serve as an effective tool for efficient experimental design and effective data interpretation. However, one remaining challenge for thermogel formulation development lies in better understanding and predicting the relationship between in-vitro drug release and in-vivo performance.
Learning Objectives:
Upon completion, participant will be able to understand the importance of investigating the impact of drug’s physicochemical properties/drug loading on the gelling temperature of thermogel formulations for small molecules
Upon completion, participant will be able to demonstrate DoE as an effective tool for efficient experimental design and effective data interpretation
Upon completion, participant will be able to examplify the disconnection between in-vitro drug release and in-vivo performance as a challenge for thermogel formulation development
