Formulation Development and Optimization of Nanoemulsion for Topical Delivery of Sertaconazole Drug to Treat Ecezema

Abstract

This study investigates the physical and chemical characteristics of Sertaconazole, focusing on its solubility, melting point, and analytical properties. Sertaconazole is a pure white substance with solubility varying by pH, being soluble in DMSO and DMF, but insoluble in water. The melting point was established at 166°C, aligning with established standards. FTIR and DSC analyses confirmed the drug's purity and crystalline nature, while PXRD showed a highly crystalline structure, indicating no polymorphic changes from milling and lyophilization. The developed analytical method exhibited strong linearity (R² = 0.999), high precision (RSD <1.1%), and near 100% accuracy in rat plasma. Robustness was validated across different solvent compositions. The QTPP analysis identified critical quality parameters, and risk analysis revealed significant factors affecting particle size and drug content in nanoformulations. Central Composite Design (CCD) optimization demonstrated enhanced drug delivery characteristics, validating the method’s effectiveness for Sertaconazole formulation optimization.