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T. B. Guerra, E. Dib, E. B. Rodrigues, F. M. Penha, A. S. Lima, O. Magalhaes, Jr., M. Maia, I. Longo Maugeri, M. E. Farah; Viability and Sterility of Bevacizumab in Different Vials and Temperature Alone and Associated With Triancinolone. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2815.
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To evaluate the viability and sterility of bevacizumab in different forms of storage or temperature alone and associated with preservative-containing triancinolone acetonide (PCTA) and preservative-free triamcinolone acetonide (PFTA).
An experimental study was conducted with four solutions: 1) 1:1 proportion of 25 mg/ml bevacizumab and saline; 2) 1:1 proportion of 25 mg/ml bevacizumab and 40 mg/ml PFTA; 3) 1:1 proportion of 25 mg/ml bevacizumab and 40 mg/ml PCTA; and 4) bevacizumab obtained from sealed vial as control group. The solutions were stored in a 1-ml disposable plastic syringe closed with a 30-gauge needle and its protective cover. Each syringe-needle complex was preserved at two different temperatures: 4-8º C (refrigerator) and -10º C (freezer). Samples were sent to microbiological analysis as 0.1 ml solution placed on a brain-heart infusion. Bevacizumab binding affinity was dosed at the time points zero, 24 h, and at day 30. Bevacizumab viability level was tested through ELISA, in which the antigen was the anti-VEGF.
All groups showed higher absorbance levels when exposed to -10ºC compared to 4° C (p = 0,0205). The association of bevacizumab plus PCTA demonstrated low absorbance of 0.08 mg/ml at day zero, and 0.24 mg/ml at day 30. These results were slightly lower than bevacizumab plus saline or PFTA. However, there were no statistically significant difference between the diluents BSS, PCTA or PFTA. Control group composed of bevacizumab only kept absorbance levels superior to group 1 in all follow-up period and temperatures. There were no microbial bacterial or fungi growth in any sample.
Placement of bevacizumab in plastic syringes may decrease drug viability. Bevacizumab stored at -10oC may be more viable than at 4oC. Association of bevacizumab plus PFTA or PCTA showed less viability than bevacizumab only.
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