title: Stability of Gentamicin Sulfate and Tobramycin Sulfate in AutoDose Infusion System Bags.
abstract: The objective of this study was to evaluate the physical and chemical stability of gentamicin sulfate 85mg/100mL and tobramycin sulfate 95mg/100mL, each of which was admixed in 0.9% sodium chloride injection and packaged in AutoDose Infusion System bags. Triplicate test samples were prepared by admixing the necessary amounts of the aminoglycoside antibiotics with a portion of 0.9% sodium chloride injection and bringing the admixture of each drug to a final volume of 100mL with additional 0.9% sodium chloride injection. The test solutions were packaged in ethylene vinyl acetate (EVA) plastic containers (AutoDose bags) designed for use in the AutoDose Infusion System. Samples were stored protected from light and were evaluated at appropriate intervals for up to 7 days at 23 deg C and up to 30 days at 4 deg C. Physical stability was assessed by means of a multistep evaluation procedure that included both turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed initially and at appropriate intervals during the study periods with stability-indicating high-performance liquid chromatographic (HPLC) analytical techniques based on the determination of drug concentrations. The aminoglycoside admixtures were clear and colorless when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. HPLC analysis indicated that both gentamicin sulfate and tobramycin sulfate remained stable for 30 days at 4 deg C and for 7 days at 23 deg C. Both gentamicin sulfate and tobramycin sulfate exhibited physical and chemical stability that were consistent with previous studies of those drugs. The AutoDose Infusion System bags did not adversely affect the physical and chemical stability of those aminoglycoside anitbiotics.
authors: Clinical Pharmaceutics Research Division, Division of Pharmacy, The University of Texas, M.D. Anderson Cancer Center, Houston, TX.
authors: Quanyun A
authors: QA
authors: Xu
authors: Lawrence A
authors: LA
authors: Trissel
authors: Christopher A
authors: CA
authors: Saenz
authors: Delshalonda S
authors: DS
authors: Ingram