Formulation Development and Compaction of Itraconazole Amorphous Solid Dispersions Tablets Using Quality by Design Principles

By MEDELPHARM

Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4ng/mL in water) requires formulation enhancement to achieve enhanced bioavailability. To tackle this problem, amorphous solid dispersions (ASDs) of ITZ in a polymer matrix (Kollidon® VA64) were produced using the Hot Melt Extrusion (HME) process.

ASDs improve the poor solubility of the BCS Class II drug, compared to its pure crystalline form. However, this enhancement is impaired at the tabletting stage due to the high dose (100mg) requirement and the presence of high polymer content (70%).

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