Introduction: Solid Lipid nanoparticles (SLN) are comprising of a solid lipid core with a mean diameter between 50 and 1000 nm. SLN is an advanced carrier system to traditional colloidal carriers such as emulsion, liposomes, and polymeric microparticles. Objective: The objective of this study was to formulate SLN of Itraconazole (ITZ) for intranasal administration. Methods: ITZ –loaded SLN were prepared by high pressure homogenization technique using central composite design (CCD). The concentration of surfactant (X1) and drug to lipid ratio (X2) were considered as independent variables whereas particle size (Y1) and percent entrapment efficiency (Y2) were considered as response. The compatibility of ingredients with drug was tested using differential scanning calorimetry. SLN were characterized for their particle size, entrapment efficiency, transmission electron microscopy, in-vitro drug release, and ex vivo study. Results: The solid lipid nanoparticles were successfully prepared using high pressure homogenization technique and glyceryl monostrearate was used as solid lipid. The lipid ratio significantly increases the particle size as well as entrapment efficiency. The particle size and (%) entrapment efficiency of optimized formulation were found to be 29 nm and 78.9% respectively. The differential scanning calorimetry confirmed that the drug existed in amorphous form. Nasal histopathology study on sheep mucosa revealed that the developed SLN were non-toxic and safe to use for intra-nasal administration. The results of ex vivo study showed that the Higuchi pattern of drug release was followed. The in-vitro release studies showed the significant difference of drug release from ITZ-loaded SLN compared to plain ITZ-solution. Conclusion: ITZ-loaded SLN were successfully prepared and validated. The best batch was selected based on the desired particle size, and EE which are an important characteristic for SLN formulations. The developed formulations were nontoxic as determined by histo-pathological studies.
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