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Article Abstract
The presence of subvisible particles in intravitreal injection ophthalmic formulations may affect drug efficacy and safety. Although Chapters 788 and 789 of the United States Pharmacopeia limit the concentration of particles ≥ 10 μm, particles less than 10 μm may cause blurred vision and floaters in the injected eyes. Due to limited access to ophthalmic protein formulations, few studies investigated the profile of subvisible particles in these formulations. In this study, the subvisible particle concentration, size distribution, and morphology of 11 intravitreal injection ophthalmic recombinant fusion protein and monoclonal antibody formulations at different drug clinical trial stages were characterized. In addition, there was significant difference in particle morphology, (circularity, compactness and etc) between unexpired and expired batches using Mann Whitney test, which was probably associated with the proportion change of protein and silicone oil particles and could be used for drug quality control at different clinical trial stages or on the market.
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| http://dx.doi.org/10.1016/j.ijpharm.2025.125500 | DOI Listing |
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