Universitas Indonesia Conferences, Asian Federation for Pharmaceutical Sciences (AFPS) 2019

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Analysis of Development History of Medical Eye Drops in Japan
Yuichiro Nakada, Junji Mukai, Kengo Mukai

Last modified: 2019-06-15


[Purpose] Eye drops is a sterile preparation and is administered multiple times, the efficacy, safety, stability and preservation must be taken into consideration. We have already reported the information of active pharmaceutical ingredients characteristics and formulations characteristics in eye drops for glaucoma, antibacterial and anti-inflammatory, which currently used in clinical practice in Japan. This time, the previously reported data was renewed the latest data, and the development transition of eye drops was summarized. Furthermore, regarding safety information was also added.

[Method] Necessary data were obtained from package inserts, interview forms and examination reports etc. accessible in the home page of PMDA. The results of these survey were consolidated and integrated, and the development transition of various eye drops was compared and examined. The obtained data were analyzed using Excel 2016 of Microsoft Corporation.

[Results and Discussion] The pH of the medical eye drops investigated was in the range of 3.7 to 8.6 and the osmotic pressure was almost 1 regardless of disease. The number of daily instillations varied depending on disease. The tendency of use of preservatives also differs depending on disease, and almost no preservative is used in medical antimicrobial eye drops, and BAK is mainly used as a preservative in other disease area. However, the BAK usage rate of anti-inflammatory eye drops was less than half, resulting in lower results compared to glaucoma eye drops and anti-allergic eye drops. One of the causes was thought to be the relatively large number of old products. Besides BAK, parabens were frequently used. In addition, polysorbate 80 was often used as a solubilizer. We will also report findings on corneal disorders when using eye drops using PMDA's adverse drug reaction database.