Background Bortezomib (Velcade) is indicated for treatment of multiple myeloma and mantle cell lymphoma.
Bortezomib is reconstituted with 0.9% sodium chloride (NS) at 1 mg/mL for intravenous administration and at 2.5 mg/mL for subcutaneous use (which has demonstrated a lower incidence of peripheral neuropathy). The product information states that in-use stability of the reconstituted solution is 8 h at 25°C in the original vial or a syringe.
Several studies have demonstrated the stability of bortezomib 1 mg/mL in NS for up to 5 days. This allows hospitals to reduce waste and results in significant cost savings. The extended stability for SC bortezomib is not yet well founded.
Purpose To determine the chemical and physical stability of 2.5 mg/mL bortezomib solution in NS stored in polypropylene syringes and opened vials under refrigerated conditions and clinical use conditions.
Materials and methods Chemical stability was defined as the retention of ≥95% of the initial drug concentration (EU approved specification limit for assay of bortezomib (Velcade)), determined by a validated HPLC method based on a previously reported HPLC method (range: 50–175 µg/mL). Degradation product levels were also measured (quantitation limit ≤ ICH reporting threshold for unidentified degradation products). Physical stability was assessed by visual inspection and dynamic light scattering. Physico-chemical stability was defined as solutions with pH values 4.0–7.0. Statistical analysis were performed (α = 0.05).
Results More than 95% of the initial concentration of bortezomib remained in the original vials and polypropylene syringes for 7 days at 5 ± 3°C and for 24 h at 25–30°C (protected from light).
All samples met the acceptance criteria for appearance, physical attributes and pH. At no time was the level of degradation products greater than the ICH reporting threshold.
Conclusions Bortezomib 2.5 mg/mL in NS was stable for 7 days at 5 ± 3°C and for 24 h at 20–30°C, when stored in both polypropylene syringes and vials (protected from light).
No conflict of interest.
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