Formulation of Ketoconazole Niosomal Delivery System using Non-Ionic Surfactants

Ketoconazole is a broad-spectrum Imidazole derivative antifungal that is effective for both superficial and systemic fungal infections that cannot be completely absorbed when administered orally because it has low solubility. This can be overcome by forming a ketoconazole niosome delivery system. Niosomes are vesicular systems formed using non-ionic surfactants that could increase the solubility and bioavailability of drugs. The purpose of this study was to form a ketoconazole niosome system to increase the bioavailability and therapeutic effectiveness of ketoconazole. Niosomes were made into nine formulas using 100 mg surfactant with variations in the combination of non-ionic surfactant concentrations Span 60 (70.80-98.29%):Sucrose Ester Palmitate (SEP) (1.71-29.20%), which produced Hydrophilic Liphophilic Balance (HLB) values between 4-8. The evaluations on niosomes were organoleptic tests, particle size tests, polydispersity indexes, zeta potentials, structural analysis using Forrier Transform Infra Red (FTIR), morphological analysis using Transmission Electron Microscope (TEM), entrapment efficiency tests and drug release tests. The results showed that the niosome system with an HLB value of 7.5 produced a vesicle size 336,13±3,14 nm, polydispersity index 0,000, zeta potensial -52,16±1,54 mV, spherical form of vesicle and no found chemistry interaction between the components (result of TEM and FTIR), an entrapment efficiency value of 87.86±0.18% and a drug release test value for 24 hours of 97.23±2.16%. This showed that the ketoconazole niosome system made using a combination of span 60 surfactants and SEP with an HLB value of 7.5 was able to produce an excellent niosome system.