Physical compatibility and chemical stability of mycophenolate mofetil during simulated Y-site administration with commonly coadministered drugs

Abstract

The physical compatibility and chemical stability of mycophenolate mofetil during simulated Y-site administration with commonly coadministered drugs were studied. The physical compatibility and chemical stability of mycophenolate mofetil were tested with cefepime, cyclosporine, dopamine, norepinephrine, tacrolimus, vancomycin, and 0.9% sodium chloride injection. Physical compatibility of mycophenolate with the test drugs was assessed visually with the unaided eye. Mycophenolate concentrations in solution were determined by a high-performance liquid chromatographic method with ultraviolet-light detection. Test drugs were added to the mycophenolate solutions, and the mycophenolate concentrations were recorded as a percentage of the original concentration based on the mean of the three control and three test concentrations. Drug combinations were considered chemically unstable if the initial mycophenolate concentration changed by > or = 10% at zero (baseline), one, two, or four hours. The mycophenolate solution remained clear and colorless after the addition of all test drugs except cyclosporine. The combination of cyclosporine with mycophenolate resulted in an effervescence that remained after four hours. Cyclosporine was the only test drug that resulted in a mean percentage change that exceeded 10% (10.3% +/- 2.3%) of the initial mycophenolate concentration. Mycophenolate mofetil was physically compatible and chemically stable with vancomycin, cefepime, norepinephrine, dopamine, and tacrolimus for up to four hours of simulated Y-site administration. The physical compatibility of mycophenolate mofetil with cyclosporine could not be confirmed.