HOT-MELT EXTRUSION FORMULATION OF ENZALUTAMIDE WITH POLYETHYLENE GLYCOL CARRIERS FOR ENHANCED SOLUBILITY AND ENTERIC COATED TABLET DELIVERY

Çağrı Talay*, Cuneyt Toprak, Gokay Gun  and Erdınc Babuc

Enzalutamide is a potent androgen receptor inhibitor used in the treatment of prostate cancer. However, it belongs to the Biopharmaceutical Classification System (BCS) Class II, characterized by low aqueous solubility and high permeability, leading to dissolution-limited absorption and variable bioavailability.[1] The present study focuses on developing a hot-melt extrusion (HME)-based solid dispersion system using polyethylene glycol (PEG 4000 and PEG 6000) as carrier polymers[2-4], followed by compression into tablets and enteric coating to ensure intestinal release. Dissolution studies demonstrated 200–300% higher drug release in optimized formulations compared to the reference marketed product (80 mg film-coated tablet). The findings confirm that PEG-based HME formulations represent a robust and scalable approach for improving solubility of poorly soluble APIs.[2,4,7]