Application bulletins
Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4 ng/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 tableting stage due to the high dose (100 mg) requirement and the presence of high polymer content (70%).
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