High particle variability across siliconized and oil-free syringes and needles from the same lots

作者: Lydianne Lumack do Monte Agra , Maurício Maia , Michel Eid Farah , John F. Carpenter , Gustavo Barreto Melo

DOI: 10.1038/S41598-021-84158-0

关键词: Oil freeSilicone oilFlow imagingMaterials scienceSyringePrimary outcomeAnimal scienceParticle

摘要: Previous studies have reported silicone oil (SO) applied to needles and syringes in the vitreous of patients after intravitreal injections. We evaluated four (SR 1-mL insulin, Saldanha-Rodrigues; BD Tuberculin Slip Tip, Becton-Dickinson; Ultra-Fine 0.3 mL, HSW Norm-Ject Tuberculin, Henke Sass Wolf) 10 (BD PrecisionGlide 27- 30-gauge (G); Eclipse JBP Nanoneedle 27-, 30-, 33- 34-G; TSK Invisible Needle 27 30-G Steriject Control Hub). The protein-free buffer samples injected into under study were collected an Eppendorf tube taken Flow imaging microscopy, that characterized concentration morphology microsized particles. number particles was analyzed. coefficients variation (CV) primary outcome. Feltz Miller test compared CVs. significance level 5%. Numerous high CVs associated with both devices, syringes; comparisons among them did not reach significance. Ultrafine 0.3 mL syringe (149.7%) had highest CV SO-free (66.4%) lowest, needle (149.5%) Precision Glide 30G (35.9%) lowest. In conclusion, particle release, including those SO morphology, varied greatly instruments, even from same lots, which is relevant considering fewer are some eyes others.

参考文章(13)
Sophie J. Bakri, Noha S. Ekdawi, Intravitreal silicone oil droplets after intravitreal drug injections. Retina-the Journal of Retinal and Vitreous Diseases. ,vol. 28, pp. 996- 1001 ,(2008) , 10.1097/IAE.0B013E31816C6868
Adelin Albert, Lixin Zhang, A novel definition of the multivariate coefficient of variation Biometrical Journal. ,vol. 52, pp. 667- 675 ,(2010) , 10.1002/BIMJ.201000030
E. Chan, A. Hubbard, S. Sane, Y.-F. Maa, Syringe Siliconization Process Investigation and Optimization Pda Journal of Pharmaceutical Science and Technology. ,vol. 66, pp. 136- 150 ,(2012) , 10.5731/PDAJPST.2012.00856
Renuka Thirumangalathu, Sampathkumar Krishnan, Margaret Speed Ricci, David N. Brems, Theodore W. Randolph, John F. Carpenter, Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution Journal of Pharmaceutical Sciences. ,vol. 98, pp. 3167- 3181 ,(2009) , 10.1002/JPS.21719
George F. Reed, Freyja Lynn, Bruce D. Meade, Use of Coefficient of Variation in Assessing Variability of Quantitative Assays Clinical and Vaccine Immunology. ,vol. 9, pp. 1235- 1239 ,(2002) , 10.1128/CDLI.9.6.1235-1239.2002
Jea H. Yu, Esmeralda Gallemore, Jisoo K. Kim, Rocky Patel, Jorge Calderon, Ron P. Gallemore, Silicone oil droplets following intravitreal bevacizumab injections. American Journal of Ophthalmology Case Reports. ,vol. 10, pp. 142- 144 ,(2017) , 10.1016/J.AJOC.2017.07.009
Dongliang Wang, Margaret K. Formica, Song Liu, Nonparametric Interval Estimators for the Coefficient of Variation The International Journal of Biostatistics. ,vol. 14, pp. 1- 15 ,(2018) , 10.1515/IJB-2017-0041
Gustavo Barreto Melo, Geoffrey Guy Emerson, Acácio Alves Souza Lima Filho, Shoko Ota, Maurício Maia, Needles as a source of silicone oil during intravitreal injection Eye. ,vol. 33, pp. 1025- 1027 ,(2019) , 10.1038/S41433-019-0365-7
Gustavo Barreto Melo, Ana Carolina Migliorini Figueira, Fernanda Aparecida Heleno Batista, Acácio Alves Souza Lima Filho, Eduardo Büchele Rodrigues, Rubens Belfort, Maurício Maia, Inflammatory Reaction After Aflibercept Intravitreal Injections Associated With Silicone Oil Droplets Released From Syringes: A Case-Control Study. Ophthalmic Surgery and Lasers. ,vol. 50, pp. 288- 294 ,(2019) , 10.3928/23258160-20190503-05