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PARTICULATE MATTER FROM SYRINGES USED FOR INTRAVITREAL INJECTIONS
Susan M Dounce1, Olga Laskina1, Roger A Goldberg2
1West Pharmaceutical Services, Inc., Exton, Pennsylvania; and.
Retina (Philadelphia, Pa.)
|September 21, 2020
Summary
Different syringes used for anti-vascular endothelial growth factor drugs impact particle load. Lubricant-free syringes minimize particles, while oleamide-lubricated ones show time-dependent increases, potentially forming visible particles in bevacizumab formulations.
Area of Science:
- Ophthalmology
- Materials Science
- Pharmaceutical Science
Background:
- Syringe preparation methods for anti-vascular endothelial growth factor (VEGF) drugs vary, impacting particle risk in retinal disease treatment.
- Syringe selection, preparation, and storage are critical factors influencing vitreous particle injection risk.
Purpose of the Study:
- To evaluate and compare particle loads generated by different syringe types over time.
- To assess the impact of syringe materials and lubricants on particle formation in drug formulations.
Main Methods:
- Four syringe types were tested: plastic (silicone oil or oleamide lubricated), glass (baked-on silicone), and lubricant-free polymer.
- Particles were quantified using flow imaging after rinsing with water or filling with buffer over time.
- Particle formation in a bevacizumab formulation was also characterized.
Main Results:
- Insulin syringes exhibited very high particle counts.
- Oleamide-lubricated syringes showed fewer initial particles but increased over time, with visible particles forming after 30 days.
- Lubricant-free polymer syringes and baked-on silicone glass syringes demonstrated low particle levels (≥10 μm), with lubricant-free syringes showing the lowest levels (≥1 μm) and minimal particle generation with bevacizumab agitation.
Conclusions:
- Intrinsic particle loads vary significantly between syringe types, affecting the final drug product.
- Oleamide-lubricated transfer syringes, often used for bevacizumab, present time-dependent particle loads and risk visible particle formation.
- Lubricant-free polymer syringes offer the lowest particle burden, crucial for intravitreal injections.
