DIQUAFOSOL-CONTAINING EYE DROPS

To provide diquafosol eye drops having stable physicochemical properties, and to provide production methods thereof.SOLUTION: In a diquafosol eye drop containing a chelator with a concentration of 0.0001 to 1% (w/v), the formation of insoluble precipitate during storage which is observed in a diquaf...

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Main Authors IKEI TATSUO, SAITO MIKIKO, SONODA MASAKI, FUKUI YOKO, HOSOI KAZUHIRO, KUWANO MITSUAKI, NAKAMURA MASATANE, SAKATANI AKIKO, INAGAKI KOJI
Format Patent
LanguageEnglish
Japanese
Published 09.05.2019
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Summary:To provide diquafosol eye drops having stable physicochemical properties, and to provide production methods thereof.SOLUTION: In a diquafosol eye drop containing a chelator with a concentration of 0.0001 to 1% (w/v), the formation of insoluble precipitate during storage which is observed in a diquafosol eye drop and the deterioration of filterability in a production process (filtration sterilization process) are inhibited. In the diquafosol eye drop containing a chelator, the alleviation of eye irritation and the enhancement of storage effect are also confirmed as compared with the diquafosol eye drop which contains no chelator. Therefore, the present invention has stable physicochemical properties in manufacturing and distribution processes as well as also in preservation process by a patient, and further the alleviation of eye irritation and the enhancement of storage effect are confirmed. In particular, since the reduction of the filtration properties in manufacturing process (filtration sterilization process) is suppressed in the diquafosol eye drop containing a chelator, efficient filtration sterilization is possible in manufacturing process, contributing to the reduction of manufacturing cost.SELECTED DRAWING: Figure 1 【課題】安定した物理化学的性質を有するジクアホソル点眼液およびその製造方法を探索すること。【解決手段】0.0001〜1%(w/v)の濃度のキレート剤を含有するジクアホソル点眼液では、ジクアホソル点眼液で認められる保存中の不溶性析出物の発生、および製造過程(ろ過滅菌過程)におけるろ過性の低下が抑制された。また、キレート剤を含有するジクアホソル点眼液では、キレート剤を含有しないジクアホソル点眼液に比して、眼刺激性の軽減および保存効力の増強も確認された。したがって、本発明は、製造および流通過程ならびに患者による保存過程においても安定した物理化学的性質を有する上、眼刺激性の軽減および保存効力の増強も確認された。特に、キレート剤を含有するジクアホソル点眼液は、製造過程(ろ過滅菌過程)におけるろ過性の低下が抑制されているため、製造過程では効率的なろ過滅菌が可能であり、製造コストの抑制に寄与する。【選択図】図1
Bibliography:Application Number: JP20190022692