(459) Early Phase Selection of a Controlled Release Amorphous Dispersion Formulation
Introduction: Currently it is estimated that over 50% of compounds in discovery and early development have poor water solubility and will require an enabling formulation technology to achieve efficacious exposure levels (1). Combining the use of amorphous solid dispersion formulation and a controlled release profile of that supersaturated solubility. For early phase screening, an in vitro test methodology was developed to evaluate (i) the stability of the amorphous form in the controlled release dosage form matrix, and (ii) the extent of supersaturation maintained after release from the dosage form.
Learning Objectives:
Understand the profile that require amorphous dispersion formulations with controlled release
Explain in vitro testing methodology and in silico model to screen ASD formulations within a CR DF
Relate the interplay of model and in vitro inputs during early formulation screening
