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Susan Dounce, Olga Laskina, Roger Goldberg; PARTICUATE MATTER FROM SYRINGES USED FOR INTRAVITREAL INJECTIONS. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4198.
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Reports of foreign material, elevations in intraocular pressure, and inflammation or infection after intravitreal injections have led to increased FDA effort to establish and enforce guidelines on repackaging bevacizumab for intravitreal injection. These guidelines, especially related to particulates, are likely to impact syringe selection by 503B outsourcing facilities. However, syringes containing anti-VEGF drugs to treat retinal diseases are prepared in a variety of ways by different parties (prefilled, repackaged, or filled at the point of care) with syringe selection, preparation, and storage conditions impacting the risk of injecting particulates into the vitreous. This study examines the particle loads from various syringes, in the absence of drug product, with immediate rinsing and over time with buffer storage. The impact of syringe selection on bevacizumab aggregation is also investigated.
Four syringes were studied: a siliconized polypropylene (PP) insulin syringe, a silicone-free PP syringe lubricated with oleamide, a glass prefilled syringe lubricated with baked-on silicone oil, and a silicone-free / lubricant-free cyclic olefin polymer (COP) prefilled syringe. Syringes were either rinsed with water or stored for up to 90 days filled with buffer; particle levels were then quantified by Flow Imaging. Particle formation after bevacizumab agitation was also characterized in the prefilled syringes.
Insulin syringes had high particle counts – orders of magnitude above USP <789> limits with water rinsing alone. Silicone-free syringes lubricated with oleamide had substantially lower particle levels versus insulin syringes but levels increased over time (leading to visible particle formation), possibly tied to the lubricant. Baked-on silicone glass syringes and silicone-free / lubricant-free COP syringes showed low particle levels in the ≥ 10 micron size range. However, the COP syringes showed the lowest overall particle levels in the ≥ 1 micron size range and the lowest particle levels with bevacizumab agitation.
Different syringes have different intrinsic particle loads which can contribute directly or indirectly (by facilitating protein aggregation) to particle loads in the delivered drug. Silicone-free PP syringes that are lubricated with oleamide have time-dependent particle loads and are associated with the formation of visible particles after 30 and 60 days of storage.
This is a 2020 ARVO Annual Meeting abstract.
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