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Stability Assessment of Repackaged Bevacizumab for Intravitreal Administration

Author(s):  Pereboom Marieke,Becker Matthijs L,Amenchar Mostapha,Verweij Sjoerd L,van der Hoeven Ruud TM,Mulder Inge J

Issue:  Jan/Feb 2015 - Volume 19, Number 1
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Abstract:  Intravitreal bevacizumab is frequently used off-label for the treatment of neovascular age-related macular degeneration, but there are concerns about the safety of intravitreal administered bevacizumab. It is suggested that repackaging bevacizumab in plastic syringes could affect the safety due to the unknown shelf life of the syringes. In this study, we analyzed the shelf life of the repackaged bevacizumab syringes, stored at 4°C, at certain time intervals. Over the 32 days tested, bevacizumab concentration and the pH were stable. However, the number of particles in the repackaged bevacizumab syringes increased during storage at 4°C and had exceeded the limits for intravitreal injections after 7 days. Since the number of particles seems to be the limitation of the shelf life of repackaged bevacizumab, it is necessary to quantify the number of particles in repackaged bevacizumab. Based on our results the maximum shelf life of repackaged bevacizumab should be 3 days.

Related Keywords: Marieke Pereboom, MSc, PharmD, Matthijs L. Becker, PharmD, PhD, Mostapha Amenchar, BSc, Sjoerd L. Verweij, MSc, PharmD, Ruud T.M. van der Hoeven, MSc, PharmD, Inge J. Mulder, MSc, PharmD, peer reviewed, bevacizumab, monoclonal antibody, intravitreal administration, neovascular age-related macular degeneration, eye diseases, ophthalmic disorders, plastic syringes, repackaging, shelf life, vascular endothelial growth factor antagonist, VEGF inhibitor, stability, particles, particulate contamination

Related Categories: OPHTHALMICS, PACKAGING, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS

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