Formulation and Evaluation of Ophthalmic Self Emulsifying Drug Delivery System of Ketoconazole

Purpose: In recent years, because of the globalization and industrialization there is Unhygienic conditions in the undeveloped countries. Pollution in developing and developed countries resulted in the a pathetic raise in the number of life-threatening infections. Because os these various reasons, there is an increase in various species of fungal infections. Poor bioavailability of ophthalmic solutions caused by dilution and drainage from the eye can be overcome by using a self-emulsifying drug delivery system. This may result in better ocular availability of the drug. Though it is a potent antifungal, according to BCS, Ketoconazole is categorized under class-2, which is having high permeability and low solubility. Thus, it suffers from a problem in formulation development with poor bioavailability and low aqueous solubility. Objective: The objective of the present study was to Formulation and Evaluation of the emulsifying drug delivery system of Ketoconazole. Methodology: The Preformulation study was carried out to identify and characterize the procured drug sample by UV spectroscopy, FTIR, and DSC. A preliminary solubility study was performed. oleic acid, Cremophore RH 40, and Propylene glycol have been utilized for the development of SMEDDS of Ketoconazole. A pseudo ternary phase diagram was constructed. 32 Factorial Design has been used for the optimization of SMEDDS. Formulated SMEDDS was evaluated for the parameters of Dilution study by visual observation, Self-emulsification time, Percentage transmission, zeta potential, particle size, and PDI. The in-vitro drug release study was carried out. The stability study of optimized formulation was carried out.