Abstract
Background: Bevacizumab, a monoclonal antibody widely used to treat cancer and eye disorders. It inhibits tumor angiogenesis by targeting Vascular Endothelial Growth Factor (VEGF), thus inhibiting the blood supply to the tumor cell. It has issues of stability with different additives during formulation and storage. Lavender essential oil is popular due to its antioxidant and antimicrobial properties, which may provide a novel strategy for enhancing protein structure in injectable preparations.
Objective: The study aimed to investigate the fitness and stability of Bevacizumab, when combined with lavender oil. The new emulsion-based parenteral product was designed to preserve the physicochemical and biological stability of Bevacizumab even when stored over an extended period of 3 months.
Methods: Lavender oil (0.5%, 1.0%, and 2.0%) of 3 different concentrations was added to the formulation. The 3 samples were subsequently stored at refrigerated (4°C), at normal room temperature (25°C) and at accelerated temperatures of 40°C for 3 months. The stability test of all 3 samples was conducted using High-Performance Liquid Chromatography (HPLC), which determined the monomer content, the percentage of degradation, and the peak area. Various auxiliary analysis techniques, including pH determination, macroscopic analysis, particle size determination, and FTIR spectroscopy, were employed to identify any shifts in physicochemical properties.
Results: Composition containing lavender oil in low concentration was more stable at refrigeration temperatures and had low degradation rates, ascertaining its potential to become a natural preservative in antibody-derived injectable biologics. No significant alteration in pH, particle size, or FTIR spectral characteristics was observed, but showed minimal degradation under accelerated temperature conditions.
Conclusion: The physicochemical stability of bevacizumab was maintained by the incorporation of lavender oil during storage. These findings highlight that lavender oil is compatible with bevacizumab in low concentration specially at refrigeration temperature.
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