European journal of hospital pharmacy : science and practice · 2016
Assessment of bevacizumab quality and stability in repackaged syringes for clinical use.
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Santoveña A, Sánchez-Negrín E, Gutiérrez F, Nazco J, Fariña J B
Аннотация
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.