Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension
In this study, we focused on the storage conditions and investigated the effects of low-temperature storage (10°C) on the dispersibility of active components in three formulations of fluorometholone (FLU) suspension eye-drops (one original drug and two generic drugs, P1-P3). For all three eye-drop p...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9632795/?tool=EBI |
| _version_ | 1811333741683933184 |
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| author | Tokio Obata Saori Deguchi Jyoji Yoshitomi Kazunori Inaba Yoko Urashima Takuro Kobori Kouichi Hosomi Noriaki Nagai Yuichiro Nakada |
| author_facet | Tokio Obata Saori Deguchi Jyoji Yoshitomi Kazunori Inaba Yoko Urashima Takuro Kobori Kouichi Hosomi Noriaki Nagai Yuichiro Nakada |
| author_sort | Tokio Obata |
| collection | DOAJ |
| description | In this study, we focused on the storage conditions and investigated the effects of low-temperature storage (10°C) on the dispersibility of active components in three formulations of fluorometholone (FLU) suspension eye-drops (one original drug and two generic drugs, P1-P3). For all three eye-drop products, before shaking by hand, white sediment anticipated to be the principal active component was seen at the vial base. In the ordinary-temperature storage group, the FLU contents per drop after shaking by hand were 0.076% in P1, 0.023% in P2, and 0.100% in P3, and the content in P2 was significantly lower than that in P1 and P3. In contrast, almost no dispersion was observed in the low-temperature group. The results after sufficient shaking of these samples with a vortex, in contrast, were such that the FLU contents per drop were 0.063% in P1, 0.086% in P2, and 0.088% in P3; the content in P1 was significantly lower than that in P2 and P3, and there was no difference between P2 and P3. Moreover, we evaluated the dispersibility according to the evaluation “Vs / (ρg − ρf) g.” In both the low- and ordinary-temperature storage groups, the value of Vs / (ρg − ρf) g, proportional to the terminal velocity, decreased in the following order: P3 > P1 ≫ P2, and each value in the ordinary-temperature was higher than that in low temperature. The zeta potential decreased in the following order: P2 > P3 ≫ P1. In conclusion, when FLU suspension eye drops are stored at low temperatures until use, such as in a refrigerator, ordinary shaking does not help achieve dispersion to the specified concentration, and even with vigorous shaking with some formulations, the specified concentration cannot be achieved. |
| first_indexed | 2024-04-13T16:57:26Z |
| format | Article |
| id | doaj.art-226310dd40134f63babdd8d5385b5ab9 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-13T16:57:26Z |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-226310dd40134f63babdd8d5385b5ab92022-12-22T02:38:46ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-011711Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspensionTokio ObataSaori DeguchiJyoji YoshitomiKazunori InabaYoko UrashimaTakuro KoboriKouichi HosomiNoriaki NagaiYuichiro NakadaIn this study, we focused on the storage conditions and investigated the effects of low-temperature storage (10°C) on the dispersibility of active components in three formulations of fluorometholone (FLU) suspension eye-drops (one original drug and two generic drugs, P1-P3). For all three eye-drop products, before shaking by hand, white sediment anticipated to be the principal active component was seen at the vial base. In the ordinary-temperature storage group, the FLU contents per drop after shaking by hand were 0.076% in P1, 0.023% in P2, and 0.100% in P3, and the content in P2 was significantly lower than that in P1 and P3. In contrast, almost no dispersion was observed in the low-temperature group. The results after sufficient shaking of these samples with a vortex, in contrast, were such that the FLU contents per drop were 0.063% in P1, 0.086% in P2, and 0.088% in P3; the content in P1 was significantly lower than that in P2 and P3, and there was no difference between P2 and P3. Moreover, we evaluated the dispersibility according to the evaluation “Vs / (ρg − ρf) g.” In both the low- and ordinary-temperature storage groups, the value of Vs / (ρg − ρf) g, proportional to the terminal velocity, decreased in the following order: P3 > P1 ≫ P2, and each value in the ordinary-temperature was higher than that in low temperature. The zeta potential decreased in the following order: P2 > P3 ≫ P1. In conclusion, when FLU suspension eye drops are stored at low temperatures until use, such as in a refrigerator, ordinary shaking does not help achieve dispersion to the specified concentration, and even with vigorous shaking with some formulations, the specified concentration cannot be achieved.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9632795/?tool=EBI |
| spellingShingle | Tokio Obata Saori Deguchi Jyoji Yoshitomi Kazunori Inaba Yoko Urashima Takuro Kobori Kouichi Hosomi Noriaki Nagai Yuichiro Nakada Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension PLoS ONE |
| title | Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension |
| title_full | Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension |
| title_fullStr | Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension |
| title_full_unstemmed | Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension |
| title_short | Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension |
| title_sort | effect of storage temperature on the dispersibility of commercially available 0 1 fluorometholone ophthalmic suspension |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9632795/?tool=EBI |
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