0000000000162833
AUTHOR
Kirsten C Spindeldreier
Loading, release and stability of epirubicin-loaded drug-eluting beads.
Purpose The aim of this study was to determine the loading efficiency, physico-chemical stability and release of epirubicin-loaded DC Bead™ (Biocompatibles UK Ltd, a BTG International group company) (bead size 70–150 µm (=DC Bead M1™) and 100–300 µm) after loading with epirubicin solution (2 mg/ml) or reconstituted powder formulation (25 mg/ml) and controlled storage. Methods DC Bead™ were loaded with 76 mg epirubicin solution (Epimedac™, Medac GmbH) or 75 mg epirubicin powder formulation (Farmorubicin™, Pharmacia Pfizer GmbH) per 2 ml of beads. Drug loading efficiency and stability were determined by measuring the epirubicin concentration in the excess solution after predetermined interval…
Physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions
Objectives This study was conducted to investigate the extended physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions in either 0.9% sodium chloride (NaCl) or 5% glucose (G5) vehicle solution. Methods A stability indicating, reverse phase, high performance liquid chromatography assay with ultraviolet detection was developed and validated. Premix solutions of cabazitaxel were prepared in the original vials. Infusion solutions were prepared in prefilled polypropylene/polyethylene (PP/PE) infusion bags (0.9% NaCl, G5) to achieve the recommended minimum and maximum cabazitaxel concentrations (0.1 mg/mL, 0.26 mg/mL). Test solutions were stored refrige…
Physico-chemical stability of eribulin mesylate containing concentrate and ready-to-administer solutions.
Objectives The aim of this study was to determine the stability of commercially available eribulin mesylate containing injection solution as well as diluted ready-to-administer solutions stored under refrigeration or at room temperature. Methods Stability was studied by a novel developed stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) assay with ultraviolet detection (detection wavelength 200 nm). Triplicate test solutions of eribulin mesylate containing injection concentrate (0.5 mg/mL) and with 0.9% sodium chloride solution diluted ready-to-administer preparations (0.205 mg/mL eribulin mesylate in polypropylene (PP) syringes, 0.020 mg/mL eribulin mesyl…