Niosome of Ketoconazole Delivery System: Optimisation Formulation and Stability Test

Ketoconazole is an antifungal drug from the Imidazole group and Biopharmaceutical Classification System (BCS) class II with very low water solubility, high permeability, and low bioavailability when administered orally. The purpose of this study was to test the physical stability of the ketoconazole niosome system, based on the previous Formula, using a combination of Span 60(S-60) and Sucrose Ester Palmitat (SEP) as surfactants with Hydrophile Lipophile Balance (HLB) values of 7 and 7.5. Evaluation of niosomes included particle size, polydispersity index, zeta potential, entrapment efficiency test, morphology imaging, and drug release test carried out for 12 weeks at temperatures of 4, 25 and 40°C. The results showed changes in particle size, polydispersity index and zeta potential at temperatures of 4, 25 and 40°C. The drug absorption efficiency test showed changes in the formula with HLB values of 7 and 7.5, from the storage at different temperatures (week 0 to week 12). Drug release test showed a decrease for two formulas (F1 and F2) at different temperatures, but they still meet the requirements. The results of the stability test showed that ketoconazole niosomes were stable when stored at 4 and 25°C because they did not experience signific.