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Taraprasad Das, Srinivas Volety, Saad Ahsan, Abhay Thakur, Savitri Sharma, Soumyava Basu, Tapas Padhi, Mohan Rao; Safety, sterility and stability of direct- from- vial multiple dosing intravitreal injection of bevacizumab. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4931.
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To determine the stability, sterility and safety of bevacizumab multiple dosing from a single vial without prior aliquoting.
Six bevacizumab vials, used in multiple patients on a single day by direct withdrawal from the vial, and stored in 4 degree C up to six months, were tested for stability (High Performance Liquid Chromatography, (HPLC) and mass spectrometry, sterility (Culture), conformational stability by circular dichroism and fluorescence spectroscopy and the rubber cap structural integrity (Electron Microscopy, EM).
HPLC of all six samples along with controls were similar. The culture was negative. The EM of the rubber cap did not show an open communication. Spectroscopic studies suggested the conformational stability of the drug. Further there was no infection or inflammation in 221 consecutive patients (973 injections) when bevacizumab was stored at 4 degree C and used for one week.
Bevacizumab does not lose stability when stored at 4 degree C for six months. 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.
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