Formulation Development and In Vitro Evaluation of Itraconazole Layered Granules

Abstract

With a wide range of action against several fungal species, including candidiasis and aspergillosis, itraconazole is an efficient and well-tolerated synthetic triazole antifungal. HPMC E5 and HPC were used as formulation factors in the fluid-bed layering process to effectively generate itraconazole-layered granules. To determine how they affected granule properties and medication release, researchers used a factorial experimental design. The drug-excipient compatibility was validated by DSC analysis, and the formulations exhibited acceptable physicochemical features and sufficient drug content. The correlation between most answers and the regression models was excellent, and the range of itraconazole release after 45 minutes was 76.4–98.4 percent. The drug release was decreased as the polymer concentration increased, with HPMC E5 having a stronger effect than HPC. The results showed that factorial design is a good fit for improving controlled-release itraconazole-layered granules.