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A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes

Intravitreal injections of antibody-based biologics targeting vascular endothelial growth factor (VEGF) are highly effective and have markedly decreased the risk of visual impairment associated with prevalent retinal diseases, such as neovascular age-related macular degeneration and diabetes macular...

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Autores principales: Lode, Heidrun Elisabeth, Gjølberg, Torleif Tollefsrud, Foss, Stian, Sivertsen, Magne Sand, Brustugun, Jørgen, Andersson, Yvonne, Jørstad, Øystein Kalsnes, Moe, Morten Carstens, Andersen, Jan Terje
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6888834/
https://www.ncbi.nlm.nih.gov/pubmed/31792234
http://dx.doi.org/10.1038/s41598-019-54226-7
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author Lode, Heidrun Elisabeth
Gjølberg, Torleif Tollefsrud
Foss, Stian
Sivertsen, Magne Sand
Brustugun, Jørgen
Andersson, Yvonne
Jørstad, Øystein Kalsnes
Moe, Morten Carstens
Andersen, Jan Terje
author_facet Lode, Heidrun Elisabeth
Gjølberg, Torleif Tollefsrud
Foss, Stian
Sivertsen, Magne Sand
Brustugun, Jørgen
Andersson, Yvonne
Jørstad, Øystein Kalsnes
Moe, Morten Carstens
Andersen, Jan Terje
author_sort Lode, Heidrun Elisabeth
collection PubMed
description Intravitreal injections of antibody-based biologics targeting vascular endothelial growth factor (VEGF) are highly effective and have markedly decreased the risk of visual impairment associated with prevalent retinal diseases, such as neovascular age-related macular degeneration and diabetes macular oedema. The diseases are chronic in their nature, and most patients need long-term therapy to suppress disease activity. We previously reported a compounding method for repackaging and storage of aflibercept (Eylea), a commonly used anti-VEGF biologic, in silicone oil-coated plastic syringes without compromising drug stability or activity. In addition to improving safety and time spent per patient, compounding of anti-VEGF biologics enables single-dose vials to be split into multiple syringes, thereby considerably reducing waste and drug expenses. However, symptomatic silicone oil droplets may deposit in the eye’s vitreous body after repetitive injections. To fully avoid this complication, we here report on a novel pharmaceutical compounding method using silicone oil-free syringes and a 33 G × 9 mm Low Dead Space Needle hub injection needle. We evaluate the method for three anti-VEGF biologics commonly used in ophthalmology: aflibercept, ranibizumab (Lucentis) and bevacizumab (Avastin). Our results show that compounding and storage for one week does not compromise the functional activity of the biologics and allows for safe and cost-effective compounding of anti-VEGF biologics for intravitreal injections in prefilled silicone oil-free syringes.
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spelling pubmed-68888342019-12-10 A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes Lode, Heidrun Elisabeth Gjølberg, Torleif Tollefsrud Foss, Stian Sivertsen, Magne Sand Brustugun, Jørgen Andersson, Yvonne Jørstad, Øystein Kalsnes Moe, Morten Carstens Andersen, Jan Terje Sci Rep Article Intravitreal injections of antibody-based biologics targeting vascular endothelial growth factor (VEGF) are highly effective and have markedly decreased the risk of visual impairment associated with prevalent retinal diseases, such as neovascular age-related macular degeneration and diabetes macular oedema. The diseases are chronic in their nature, and most patients need long-term therapy to suppress disease activity. We previously reported a compounding method for repackaging and storage of aflibercept (Eylea), a commonly used anti-VEGF biologic, in silicone oil-coated plastic syringes without compromising drug stability or activity. In addition to improving safety and time spent per patient, compounding of anti-VEGF biologics enables single-dose vials to be split into multiple syringes, thereby considerably reducing waste and drug expenses. However, symptomatic silicone oil droplets may deposit in the eye’s vitreous body after repetitive injections. To fully avoid this complication, we here report on a novel pharmaceutical compounding method using silicone oil-free syringes and a 33 G × 9 mm Low Dead Space Needle hub injection needle. We evaluate the method for three anti-VEGF biologics commonly used in ophthalmology: aflibercept, ranibizumab (Lucentis) and bevacizumab (Avastin). Our results show that compounding and storage for one week does not compromise the functional activity of the biologics and allows for safe and cost-effective compounding of anti-VEGF biologics for intravitreal injections in prefilled silicone oil-free syringes. Nature Publishing Group UK 2019-12-02 /pmc/articles/PMC6888834/ /pubmed/31792234 http://dx.doi.org/10.1038/s41598-019-54226-7 Text en © The Author(s) 2019 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Lode, Heidrun Elisabeth
Gjølberg, Torleif Tollefsrud
Foss, Stian
Sivertsen, Magne Sand
Brustugun, Jørgen
Andersson, Yvonne
Jørstad, Øystein Kalsnes
Moe, Morten Carstens
Andersen, Jan Terje
A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title_full A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title_fullStr A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title_full_unstemmed A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title_short A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes
title_sort new method for pharmaceutical compounding and storage of anti-vegf biologics for intravitreal use in silicone oil-free prefilled plastic syringes
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6888834/
https://www.ncbi.nlm.nih.gov/pubmed/31792234
http://dx.doi.org/10.1038/s41598-019-54226-7
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