Santoveña A, Sánchez-Negrín E, Gutiérrez F, Nazco J, Fariña J B
Instituto de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna, La Laguna, Tenerife, Spain.
Servicio de Farmacia Hospitalaria, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain.
Eur J Hosp Pharm. 2016 Nov;23(6):343-347. doi: 10.1136/ejhpharm-2015-000853. Epub 2016 Mar 21.
Among measures taken to optimise financial resources, the off-label use of bevacizumab (Avastin) in the treatment of age-related macular degeneration (AMD) involves its repackaging from higher volume dosage forms. This use requires studies to analyse the viability of the repackaged preparations to ensure their quality, safety and efficacy. Our aim was to assess the structural stability and particle size of bevacizumab after it was repackaged from the original glass vials and stored in plastic syringes.
High performance liquid chromatography by size exclusion (HPLC-SE) was used to quantify the bevacizumab and determine its degradation products after stress stability testing, with a particle size counter employed after repackaging and subsequent storage.
The syringes stored for 3 days at 4°C maintained the area of the main chromatographic peak above 100±10% of its initial value, and the observed particle size is the same as at baseline (20 nm) but with a double distribution towards larger sizes.
This study shows how the repackaging of Avastin in plastic syringes permits their use for 3 days if stored under normal refrigeration. In this way, hospital pharmacy services can help optimise health resources without compromising the pharmaceutical standards of the drug.
在优化财政资源所采取的措施中，贝伐单抗（阿瓦斯汀）在治疗年龄相关性黄斑变性（AMD）时的超说明书使用涉及将其从高容量剂型重新包装。这种使用需要进行研究以分析重新包装制剂的可行性，以确保其质量、安全性和有效性。我们的目的是评估贝伐单抗从原始玻璃瓶重新包装并储存在塑料注射器中后的结构稳定性和粒径。
采用尺寸排阻高效液相色谱法（HPLC-SE）对贝伐单抗进行定量，并在强制稳定性试验后测定其降解产物，重新包装并随后储存后使用粒径计数器。
在4°C下储存3天的注射器，其主要色谱峰面积维持在初始值的100±10%以上，观察到的粒径与基线时相同（20 nm），但向较大尺寸有双峰分布。
本研究表明，如果在正常冷藏条件下储存，将阿瓦斯汀重新包装在塑料注射器中可使用3天。通过这种方式，医院药房服务可以帮助优化卫生资源，而不影响药物的药学标准。
