INCREASING SOLUBILITY AND THERMAL STABILITY OF AMORPHOUS SOLID DISPERSION VENETOCLAX PREPARED BY SPRAY DRYING METHOD

Canberk YILMAZ*, Cuneyt TOPRAK, Gokay GUN and Erdınc BABUC

Venetoclax is a selective BCL-2 inhibitor used in the treatment of hematological malignancies such as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Despite its clinical importance, it is classified as a Biopharmaceutical Classification System (BCS) Class IV compound due to its low water solubility and permeability, making oral formulation development challenging. The overall objective of this study was to improve the solubility of venetoclax by preparing an amorphous solid dispersion (ASD) and to provide an alternative venetoclax dispersion with a more stable structure than the reference product produced using a hot melt extruder manufacturing method under high stress conditions.