Silicone oil-free syringes, siliconized syringes and needles: quantitative assessment of silicone oil release with drugs used for intravitreal injection.
intravitreal injection
needle
silicone oil
silicone oil-free syringe
syringe
Journal
Acta ophthalmologica
ISSN: 1755-3768
Titre abrégé: Acta Ophthalmol
Pays: England
ID NLM: 101468102
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
revised:
17
01
2021
received:
30
11
2020
accepted:
23
02
2021
pubmed:
24
4
2021
medline:
28
1
2022
entrez:
23
4
2021
Statut:
ppublish
Résumé
This study aimed to quantify the amount of silicone oil (SO) released across a variety of syringe and needle models routinely used for intravitreal injection. The release of SO was assessed in eight models of syringes, two of which were reported to be 'SO-free', and eleven models of needles with unknown SO content. To evaluate SO release within the context of anti-VEGF therapeutics, syringes were evaluated using aflibercept, bevacizumab, buffer, ziv-aflibercept and formulation buffer. All syringe tests were performed with or without agitation by flicking for syringes. Needles were evaluated without agitation only. Samples were fluorescently labelled to identify SO, and triplicate measurements were collected using imaging flow cytometry. Seven out of 8 syringe models showed a statistically significant increase in the SO particle count after agitation. The two SO-free syringe models (HSW Norm-Ject, Daikyo Crystal Zenith) released the least SO particles, with or without agitation, whereas the BD Ultra-Fine and Saldanha-Rodrigues syringes released the most. More SO was released when the syringes were prefilled with formulation buffer than with ziv-aflibercept. Syringes filled with aflibercept and bevacizumab had intermediate levels. Agitation increased the release of SO into each of the drug solutions. Silicone oil (SO) was detected in all needles. Agitation of the syringe by flicking leads to a substantial increase in the number of SO particles. Silicone oil (SO)-free syringes had the best performance, but physicians must also be aware that needles are siliconized and also contribute to the injection of SO into the vitreous.
Substances chimiques
Angiogenesis Inhibitors
0
Silicone Oils
0
Silicon
Z4152N8IUI
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1366-e1374Subventions
Organisme : JILA, University of Colorado
Informations de copyright
© 2021 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Références
Abrahams C, Melo GB & Wambier CG (2020): Silicone-rich syringes can cause granuloma-rich reactions in platelet-rich plasma injections. JAAD Case Rep 6: 751-752.
Avery RL, Castellarin AA, Dhoot DS et al. (2019): Large silicone droplets after intravitreal bevacizumab (Avastin). Retin Cases Brief 13: 130-134.
Bakri SJ & Ekdawi NS (2008): Intravitreal silicone oil droplets after intravitreal drug injections. Retina 28: 996-1001.
Carpenter JF, Randolph TW, Jiskoot W et al. (2009): Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci 98: 1201-1205.
Chisholm CF, Baker AE, Soucie KR, Torres RM, Carpenter JF & Randolph TW (2016): Silicone oil microdroplets can induce antibody responses against recombinant murine growth hormone in mice. J Pharm Sci 105: 1623-1632.
Chisholm CF, Nguyen BH, Soucie KR, Torres RM, Carpenter JF & Randolph TW (2015): In vivo analysis of the potency of silicone oil microdroplets as immunological adjuvants in protein formulations. J Pharm Sci 104: 3681-3690.
Cohen Tervaert JW, Colaris MJ & van der Hulst RR (2017): Silicone breast implants and autoimmune rheumatic diseases: myth or reality. Curr Opin Rheumatol 29: 348-354.
Dias Júnior CS, Cardoso AL, Figueiredo AGA, Ota S & Melo GB (2020): Agitation of the syringe and release of silicone oil. Eye 34: 2242-2248.
Dounce S, Laskina O & Goldberg R (2020): Particulate matter from syringes used for intravitreal injections. Invest Ophthalmol Vis Sci 61: 4198.
Emerson GG (2017): Silicone oil droplets are more common in fluid from BD insulin syringes as compared to other syringes. J VitreoRet Dis 1: 401-406.
Funke S, Matilainen J, Nalenz H, Bechtold-Peters K, Mahler HC & Friess W (2015): Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy. Eur J Pharm Biopharm 96: 304-313.
Hahn P, Kim JE, Stinnett S et al.; American Society of Retina Specialists Therapeutic Surveillance Committee (2013): Aflibercept-related sterile inflammation. Ophthalmology 120: 1100-1101.e1-5.
Hermeling S, Aranha L, Damen JM, Slijper M, Schellekens H, Crommelin DJ & Jiskoot W (2005): Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b. Pharm Res 22: 1997-2006.
Jones MT, Mahler HC, Yadav S et al. (2018): Considerations for the use of polysorbates in biopharmaceuticals. Pharm Res 35: 148.
Khurana RN, Chang LK & Porco TC (2017): Incidence of presumed silicone oil droplets in the vitreous cavity after intravitreal bevacizumab injection with insulin syringes. JAMA Ophthalmol 135: 800-803.
Kim NA, Kim DJ & Jeong SH (2020): Do not flick or drop off-label use plastic syringes in handling therapeutic proteins before administration. Int J Pharm 587: 119704.
Krayukhina E, Tsumoto K, Uchiyama S & Fukui K (2015): Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins. J Pharm Sci 104: 527-535.
Krayukhina E, Yokoyama M, Hayashihara KK et al. (2019): An assessment of the ability of submicron- and micron-size silicone oil droplets in dropped prefillable syringes to invoke early- and late-stage immune responses. J Pharm Sci 108: 2278-2287.
Lebron JA, Wolf JJ, Kaplanski CV & Ledwith BJ (2007): Nonclinical safety assessment of vaccines and the evaluation of novel adjuvants and delivery systems. In: Singh M, (ed.). Vaccine Adjuvants and Delivery Systems. New York: Wiley 403-420.
Melo GB, Cruz NFSD, Emerson GG et al. (2021): Critical analysis of techniques and materials used in devices, syringes, and needles used for intravitreal injections. Prog Retin Eye Res 80: 100862.
Melo GB, Dias Junior CS, Morais FB et al. (2019): Prevalence of silicone oil droplets in eyes treated with intravitreal injection. Int J Retina Vitreous 5: 34.
Melo GB, Emerson GG, Dias CS Jr et al. (2020): Release of silicone oil and the off-label use of syringes in ophthalmology. Br J Ophthalmol 104: 291-296.*
Melo GB, Emerson GG, Lima Filho AAS, Ota S & Maia M (2019): Needles as a source of silicone oil during intravitreal injection. Eye 33: 1025-1027.**
Melo GB, Figueira ACM, Batista FAH, Lima Filho AAS, Rodrigues EB, Belfort R & Maia M (2019): Inflammatory reaction after aflibercept intravitreal injections associated with silicone oil droplets released from syringes: a case-control study. Ophthalmic Surg Lasers Imaging. Retina 50: 288-294.*
Probst C (2020): Characterization of protein aggregates, silicone oil droplets, and protein-silicone interactions using imaging flow cytometry. J Pharm Sci 109: 364-374.
Rosenberg AS (2006): Effects of protein aggregates: an immunologic perspective. AAPS J 8:E501-E507.
Sacha GA, Saffell-Clemmer W, Abram K & Akers MJ (2010): Practical fundamentals of glass, rubber, and plastic sterile packaging systems. Pharm Dev Technol 15: 6-34.
Schargus M, Werner BP, Geerling G & Winter G (2018): Contamination of anti-vegf drugs for intravitreal injection: how do repackaging and newly developed syringes affect the amount of silicone oil droplets and protein aggregates? Retina 38: 2088-2095.
Scott IU, Oden NL, VanVeldhuisen PC. (2009). SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol 148: 725-732.e7.
Shoenfeld Y & Agmon-Levin N (2011): 'ASIA' - autoimmune/inflammatory syndrome induced by adjuvants. J Autoimmun 36: 4-8.
Spohn G & Bachmann MF (2008): Exploiting viral properties for the rational design of modern vaccines. Expert Rev Vaccines 7: 43-54.
Teska BM, Brake JM, Tronto GS & Carpenter JF (2016): Aggregation and particle formation of therapeutic proteins in contact with a novel fluoropolymer surface versus siliconized surfaces: effects of agitation in vials and in prefilled syringes. J Pharm Sci 105: 2053-2065.
Thompson JT (2020): Prospective study of silicone oil microdroplets in eyes receiving intravitreal anti-vascular endothelial growth factor therapy in 3 different syringes. Ophthalmol Retina 5: 234-240.
Uchino T, Miyazaki Y, Yamazaki T & Kagawa Y (2017): Immunogenicity of protein aggregates of a monoclonal antibody generated by forced shaking stress with siliconized and nonsiliconized syringes in BALB/c mice. J Pharm Pharmacol 69: 1341-1351.
Wambier CG, Assis de Andrade E, Cruz LS et al. (2019): Flush technique to minimize adverse reactions from syringe lubricant (silicone oil). J Am Acad Dermatol 81: e169-e171.
Wambier CG, Danilau Ostroski TK, de Farias P, Wambier S, Beltrame FL, Cappel MA & Pineiro Maceira JM (2018): Syringe lubricant and adverse reactions. Int J Dermatol 57: 122-123.