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

ABSTRACT: 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

SUBMITTER: Obata T 

PROVIDER: S-EPMC9632795 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature