医療用緑内障点眼剤の開発変遷の分析

抄録

From descriptions on the package inserts and interview forms accessible on the home page of the Pharmaceuticals and Medical Devices Agency (PMDA), the characteristics of active pharmaceutical ingredients, pharmaceutical production, and formulations of 106 glaucoma therapeutic agents currently used in clinical practice in Japan were analyzed. Since eye drops are a sterile preparation and are administered multiple times, their efficacy, safety, stability and preservation must be taken into consideration. The pH (4-8) and osmotic pressure (0.6-1.6) were well controlled within a fixed range and some additives were compounded in the eye drops for the purpose of making the users feel more comfortable. It was also found that there was a difference in the use of solubilizing agents and preservatives between domestic and global pharmaceutical companies. There has been no article to compare the eye drop formulations of glaucoma therapeutic agents for 45 years; therefore, this paper will help to show future directionality of the preparation development of eye drops.