Effect of Shelf Life on the Physical Stability of Suspended Ophthalmic Solutions

Nakada, Yuichiro; Yamaguchi, Mizuki; Deguchi, Saori; Inaba, Kazunori; Nagai, Noriaki

doi:10.1248/yakushi.21-00005

Cited by 1 publication

(4 citation statements)

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“…Simultaneously, almost no FLU was detected in any of the samples of eye-drops (Fig 6). These findings showed that no dispersion occurred with ordinary shaking by hand As against the above results, the present authors have previously reported that most of the sediment was eliminated by shaking by hand after short-term and long-term storage at the ambient temperature in the months of June to August [1]. This suggests that storage at low temperatures affects the dispersion of the sediment.…”

Section: Plos Onesupporting

confidence: 80%

“…As against the above results, the present authors have previously reported that most of the sediment was eliminated by shaking by hand after short-term and long-term storage at the ambient temperature in the months of June to August [ 1 ]. This suggests that storage at low temperatures affects the dispersion of the sediment.…”

Section: Discussionsupporting

confidence: 65%

“…Many drugs incorporated in eye-drops have low water solubility, and in such cases, aqueous-suspension eye-drops and eye ointments are considered the ideal dosage forms [ 1 ]. These aqueous-suspension eye-drops are aqueous formulations prepared by suspending poorly soluble drugs as fine crystals or fine powder in aqueous media.…”

Section: Introductionmentioning

confidence: 99%

“…We previously investigated the effect of the storage duration of original and generic drugs for FLU eye-drops on the drug content per drop and their physical stability (dispersibility and particle diameter) after mixing by shaking by hand. With several generic products, it was shown that, unlike the original drugs, gentle mixing does not allow the drug concentration to reach the recommended levels [ 1 ]. These findings suggest that storage of FLU eye-drops has a significant effect on their dispersion stability and thus on drug delivery during administration.…”

Section: Introductionmentioning

confidence: 99%

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Effect of storage temperature on the dispersibility of commercially available 0.1% fluorometholone ophthalmic suspension

et al. 2022

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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.

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Section: Plos Onesupporting

confidence: 80%

Section: Discussionsupporting

confidence: 65%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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