Das Taraprasad, Volety Srinivas, Ahsan Saad M, Thakur Abhay K, Sharma Savitri, Padhi Tapas R, Basu Soumyava, Rao Ch Mohan
Retina Vitreous, L V Prasad Eye Institute, Bhubaneswar, India.
Microbiology, L V Prasad Eye Institute, Bhubaneswar, India.
Clin Exp Ophthalmol. 2015 Jul;43(5):466-73. doi: 10.1111/ceo.12489. Epub 2015 Apr 14.
This study aims to determine the stability, sterility and safety of bevacizumab multiple dosing from a single vial without prior aliquoting.
In-vitro and human study. Six bevacizumab vials, used in multiple patients on a single day by direct withdrawal from the vial, and stored in 4°C up to a variable period, were tested for stability (high-performance liquid chromatography; [HPLC]), sterility (culture), conformational stability by circular dichroism and fluorescence spectroscopy and the rubber cork structural integrity (electron microscopy [EM]).
HPLC of all six samples of used bevacizumab and the control bevacizumab sample were similar; culture was negative; and the EM of rubber corks did not show an open communication. Spectroscopic studies indicated drug conformational stability. Further, there was no infection or inflammation in 221 consecutive patients (973 injections) when bevacizumab was stored at 4°C and used for one week.
Bevacizumab does not lose stability when stored at 4°C. It may be used for a week by direct withdrawal from the vial without fear of infection or inflammation if all standard precautions related to intravitreal injection are adhered to.
本研究旨在确定不预先分装而从单个小瓶中多次给药的贝伐单抗的稳定性、无菌性和安全性。
体外研究和人体研究。对6个贝伐单抗小瓶进行测试，这些小瓶在同一天直接从小瓶中取出供多名患者使用，并在4°C下保存不同时间，检测其稳定性（高效液相色谱法；[HPLC]）、无菌性（培养）、通过圆二色性和荧光光谱法检测的构象稳定性以及橡胶瓶塞的结构完整性（电子显微镜[EM]）。
所有6个使用过的贝伐单抗样品和对照贝伐单抗样品的HPLC结果相似；培养结果为阴性；橡胶瓶塞的EM未显示有开放连通。光谱研究表明药物构象稳定。此外，当贝伐单抗在4°C下保存并使用一周时，221例连续患者（973次注射）中未出现感染或炎症。
贝伐单抗在4°C下保存时不会失去稳定性。如果遵守与玻璃体内注射相关的所有标准预防措施，它可以直接从小瓶中取出使用一周，而无需担心感染或炎症。
