Preparation and Physicochemical Evaluation of Eye Drop Formulation Based on Hyaluronic Acid and Vitamin B12

Abstract

Background Dry eye disease is a common age-related disease in the world. Vitamin B12 is an essential factor in maintaining eye health and has antioxidant properties that protect the surface of the eye from damage caused by harmful factors, such as reactive oxygen species. Hyaluronic acid polymer is also similar to natural eye tears with its biocompatibility and physical properties. This polymer is one of the important components of the extracellular matrix. Objective Due to the lack of formulations containing the combination of vitamin B12 and hyaluronic acid in the country and the appropriate effects of these two compounds for dry eyes, this study formulates and analyzes the stability of eye drop formulation based on hyaluronic acid and vitamin B12. Methods First, the formulation of hyaluronic acid and vitamin B12 solution with borate buffer was prepared and the stability of vitamin B12 was evaluated. Next, the physicochemical properties of the prepared formulations were evaluated and a sterile ophthalmic solution was prepared from the selected formulations under aseptic conditions. Finally, by choosing the final formulation, accelerated stability was achieved. Results Accelerated studies after six months showed that the amount of vitamin B12 and its ultraviolet absorption did not decrease, and the physicochemical properties, such as solution pH, color, and viscosity did not change. Conclusion This formulation could be a good candidate for industrial production and long-term stability studies are recommended.