The present invention relates to an
eye drop composition for treating dry eye syndrome, characterized in that the
eye drop composition remains stable during storage without
precipitation occurring andcontains a safe ingredient for use as an
eye drop, by solubilizing
rebamipide that is a poorly soluble compound, and a method for producing the same. The eye drop composition for treating dry eye syndrome of the present invention includes a base for solubilizing
rebamipide, and is characterized by containing a stabilizer for maintaining a supersaturated stabilized state, a specific type of bufferfor maintaining biocompatible pH of 7 to 8 and an osmotic agent. A method for producing the same comprises the steps of: adding a base to
rebamipide or a pharmaceutically acceptable salt thereof anda stabilizer and dissolving the same in water to obtain an aqueous eye
drop solution of pH of 10 to pH of 11; adding at least one osmotic agent selected from a buffer and a nonionic osmotic agent to the eye
drop solution and dissolving the same; and after adjusting the pH to 7 to 8 with an acid, filtering the solution with a
syringe filter to make the same sterile. The produced eye drop is in theform of an
aqueous solution, is stable when frozen, refrigerated, and at
room temperature, and includes a therapeutic agent for dry eye syndrome which is stable even when cross-stored in a refrigerator or at
room temperature, or at a refrigerating temperature or
room temperature.