著者

落合 明子 飯田 桂 髙部 浩行 川村 恵里 佐藤 康彦 加藤 保富 大熊 盛之 檀上 和美

出版者

公益社団法人 日本薬剤学会

雑誌

薬剤学 (ISSN:03727629)

巻号頁・発行日

vol.70, no.6, pp.324-331, 2010 (Released:2019-03-08)

参考文献数

18

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Latanoprost tends to degrade in an aqueous solution, and also adsorbs to the plastic containers. Moreover, the latanoprost content of the formulation can easily degrade, depending on the storage temperature, because of the very low drug concentration in the eye drops. Therefore, Xalatan® Eye Drops should be stored at 2-8°C (in the refrigerator)for the reasons described above.In this study, we investigated ways to improve the stability of latanoprost in aqueous solution in order to develop a formulation of latanoprost eye drops that can be stored at room temperature (1-30°C). Excipients used for opthalmological preparations were examined. The stability at 60°C was evaluated after 4 weeks in model formulations that included the excipient, which enables sterile filtration. As a result, the latanoprost content was not decreased in formulations that included polyoxyl 40 stearate and polyethylene glycol monostearate 25 at suitable concentrations. Then, we established a formulation of latanoprost eye drops that could be stored at room temperature. It was assumed that both the degradation of latanoprost and adsorption to the plastic containers were depressed by these excipients.The formulation developed in this study would not need to be stored in the refrigerator either during the medication period of the patient or during distribution and storage at medical sites. It was also predicted that instructions on the use of these drugs would be simplified. Therefore, the latanoprost eye drops developed in this study would be very useful for patients and health care professionals.