Compatibility of Ketorolac Tromethamine Injection with Common Infusion Fluids and Administration Sets

Abstract

The compatibility of ketorolac tromethamine injection with commonly used i.v. infusion solutions and administration set components was evaluated. The infusion solutions tested were 0.9% sodium chloride injection, 5% dextrose injection, 0.9% sodium chloride and 5% dextrose injection, Plasma-Lyte A pH 7.4 injection, Ringer's injection, and lactated Ringer's injection. The ketorolac tromethamine admixture concentration studied was 30 mg/50 mL for all solutions. Admixtures were stored in polyvinyl chloride bags and glass bottles at room temperature under fluorescent light and sampled at 0, 6, 24, and 48 hours. Chemical compatibility was determined by high-performance liquid chromatography, and physical compatibility was determined by visual analysis, counting of subvisible particles by HIAC, and pH measurements. Adsorption of ketorolac tromethamine to i.v. administration set components was also evaluated. Ketorolac tromethamine exhibited excellent physical and chemical stability in all six infusion solutions tested. No degradation of drug, formation of particulates, or adsorption to containers or infusion tubing was noted at any concentration for any of the solutions. After the solutions were mixed, the pH remained essentially unchanged. Ketorolac tromethamine injection was physically and chemically stable when mixed with a variety of commonly used infusion solutions and was not adsorbed to administration set components or to glass or polyvinyl chloride containers.