Stability of methylprednisolone sodium succinate in autodose infusion system bags. 2002

Lawrence A Trissel, and Yanping Zhang
Division of Pharmacy, M.D. Anderson Cancer Center, University of Texas, Houston, Tex 77030, USA.

OBJECTIVE To evaluate the physical and chemical stabilities of methylprednisolone sodium succinate solutions packaged in sterile AutoDose Infusion System bags. METHODS Laboratory. METHODS The test samples were prepared by reconstituting the methylprednisolone sodium succinate, adding the required amount of drug to the AutoDose Infusion System bags, and diluting to the target concentrations of 100 mg/100 mL and 1 gram/100 mL with 0.9% Sodium Chloride Injection. METHODS Physical stability and chemical stability based on drug concentrations initially and at appropriate intervals over periods up to 3 days at 23 degrees C and 30 days at 4 degrees C. RESULTS The admixtures initially were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change. All samples were essentially colorless throughout the study. High-performance liquid chromatography analysis revealed some decomposition in the samples. Methylprednisolone sodium succinate exhibited about 8% loss after 2 days and about 13% loss after 3 days at 23 degrees C. In the samples stored at 4 degrees C, methylprednisolone sodium succinate exhibited acceptable stability through 21 days of storage, but losses exceeded 10% after 30 days. CONCLUSIONS Methylprednisolone sodium succinate exhibited physical and chemical stabilities consistent with those found in previous studies. The AutoDose Infusion System bags did not adversely affect the physical or chemical stability of this drug.

UI MeSH Term Description Entries
D007262 Infusions, Intravenous The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it. Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D008776 Methylprednisolone Hemisuccinate A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies. Methylprednisolone Succinate,6 alpha-Methylprednisolone Sodium Hemisuccinate,A-MethaPred,Methylprednisolone Hemisuccinate Monosodium Salt,Methylprednisolone Sodium Hemisuccinate,Methylprednisolone Sodium Succinate,Solu-Medrol,Solumedrol,Urbason-Soluble,Hemisuccinate, Methylprednisolone,Sodium Hemisuccinate, Methylprednisolone,Sodium Succinate, Methylprednisolone,Succinate, Methylprednisolone,UrbasonSoluble
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004349 Drug Packaging Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available. Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D013696 Temperature The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms. Temperatures

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