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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.
Sci Rep. 2019 12 02; 9(1):18021.SR

Abstract

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.

Authors+Show Affiliations

Department of Immunology, Oslo University Hospital Rikshospitalet, Oslo, Norway. Institute of Clinical Medicine and Department of Pharmacology, University of Oslo and Oslo University Hospital, Oslo, Norway. Department of Ophthalmology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.Department of Immunology, Oslo University Hospital Rikshospitalet, Oslo, Norway. Institute of Clinical Medicine and Department of Pharmacology, University of Oslo and Oslo University Hospital, Oslo, Norway. Department of Ophthalmology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.Department of Immunology, Oslo University Hospital Rikshospitalet, Oslo, Norway. Institute of Clinical Medicine and Department of Pharmacology, University of Oslo and Oslo University Hospital, Oslo, Norway. Department of Biosciences, University of Oslo, Oslo, Norway.Department of Ophthalmology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.Hospital Pharmacies Enterprise, South-Eastern Norway Regional Health Authority, Oslo, Norway.Hospital Pharmacies Enterprise, South-Eastern Norway Regional Health Authority, Oslo, Norway.Department of Ophthalmology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.Department of Ophthalmology, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway. m.c.moe@medisin.uio.no.Department of Immunology, Oslo University Hospital Rikshospitalet, Oslo, Norway. j.t.andersen@medisin.uio.no. Institute of Clinical Medicine and Department of Pharmacology, University of Oslo and Oslo University Hospital, Oslo, Norway. j.t.andersen@medisin.uio.no.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31792234

Citation

Lode, Heidrun Elisabeth, et al. "A New Method for Pharmaceutical Compounding and Storage of anti-VEGF Biologics for Intravitreal Use in Silicone Oil-free Prefilled Plastic Syringes." Scientific Reports, vol. 9, no. 1, 2019, p. 18021.
Lode HE, Gjølberg TT, Foss S, et al. A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes. Sci Rep. 2019;9(1):18021.
Lode, H. E., Gjølberg, T. T., Foss, S., Sivertsen, M. S., Brustugun, J., Andersson, Y., Jørstad, Ø. K., Moe, M. C., & Andersen, J. T. (2019). A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes. Scientific Reports, 9(1), 18021. https://doi.org/10.1038/s41598-019-54226-7
Lode HE, et al. A New Method for Pharmaceutical Compounding and Storage of anti-VEGF Biologics for Intravitreal Use in Silicone Oil-free Prefilled Plastic Syringes. Sci Rep. 2019 12 2;9(1):18021. PubMed PMID: 31792234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes. AU - Lode,Heidrun Elisabeth, AU - Gjølberg,Torleif Tollefsrud, AU - Foss,Stian, AU - Sivertsen,Magne Sand, AU - Brustugun,Jørgen, AU - Andersson,Yvonne, AU - Jørstad,Øystein Kalsnes, AU - Moe,Morten Carstens, AU - Andersen,Jan Terje, Y1 - 2019/12/02/ PY - 2019/06/24/received PY - 2019/11/06/accepted PY - 2019/12/4/entrez PY - 2019/12/4/pubmed PY - 2019/12/4/medline SP - 18021 EP - 18021 JF - Scientific reports JO - Sci Rep VL - 9 IS - 1 N2 - 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. SN - 2045-2322 UR - https://www.unboundmedicine.com/medline/citation/31792234/A_new_method_for_pharmaceutical_compounding_and_storage_of_anti_VEGF_biologics_for_intravitreal_use_in_silicone_oil_free_prefilled_plastic_syringes_ DB - PRIME DP - Unbound Medicine ER -
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