ITRACONAZOLE SELF-NANOEMULSIFYING DRUG DELIVERY SYSTEM: A COMPREHENSIVE STUDY ON BCS CLASS II DRUG TRANSFORMATION FOR OPTIMAL ORAL DELIVERY

• DOI: 10.71000/cv3d6d35
• Publication Date: 2025-02-10T03:46:00Z
• Authors: Abdul Rauf; Fahad Pervaiz; Hafiz Muhammad Us...; Khadija Karim; Sadia Rehman; Memoona Qayyum; Mudassara Liaqat; Rida Akhtar; Tahreem Arshad; Abdul Hassan Khan

Background: Itraconazole, a BCS Class II antifungal agent, exhibits poor water solubility and variable oral bioavailability, limiting its therapeutic efficacy. Self-nanoemulsifying drug delivery systems (SNEDDS) have emerged as an effective strategy for improving dissolution absorption. By enhancing ensuring rapid release, SNEDDS formulations offer promising alternative to conventional dosage forms. This study focuses on the development evaluation of optimized formulation itraconazole improve bioavailability potential. Objective: aimed formulate characterize itraconazole, improved solubility, stability, performance compared formulations. Methods: Pseudo-ternary phase diagrams were employed optimize formulation, selecting oleic acid oil phase, Tween 80 surfactant, PEG 200 co-surfactant. Twenty-seven initially prepared, out which six shortlisted based isotropic properties. Formulations underwent rigorous characterization, including visual inspection, thermodynamic stability studies, freeze-thaw cycling, centrifugation tests, self-emulsification time analysis, cloud point determination, robustness dilution, Fourier Transform Infrared (FTIR) spectroscopy. In vitro release was evaluated using USP Type apparatus. Results: Among formulations, IT3 exhibited highest optimal self-emulsification, achieving complete in 180 minutes. Other demonstrated 240 360 minutes, while commercial Sporanox capsule released only 67% after 600 Thermodynamic studies confirmed that most stable, receiving "excellent" rating, IT4 IT6 classified "good." Cloud analysis showed up 80°C, dilution no separation even 1000-fold dilution. FTIR spectroscopy compatibility between excipients. Conclusion: The significantly rate outperforming highlights potential poorly soluble drugs, providing robust approach enhanced