• Am J Health Syst Pharm · Jan 1997

    Stability of tacrolimus in an extemporaneously compounded oral liquid.

    • P A Jacobson, C E Johnson, N J West, and J A Foster.
    • Bone Narrow Transplantation, University of Michigan Health System (UMHS), Ann Arbor, USA.
    • Am J Health Syst Pharm. 1997 Jan 15; 54 (2): 178-80.

    AbstractThe stability of tacrolimus in an extemporaneously compounded oral liquid formulation was studied. A suspension was prepared by mixing the contents of commercially available 5-mg capsules of tacrolimus with equal amounts of Ora-Plus and Simple Syrup, NF, to make a final volume of 60 mL. The final concentration of tacrolimus in the suspension was 0.5 mg/mL. Six identical suspensions were prepared, placed in three glass and three plastic amber prescription bottles, and stored at room temperature (24-26 degrees C). Immediately after preparation and at 7, 15, 30, 45, and 56 days, samples were removed and assayed in duplicate by stability-indicating high-performance liquid chromatography. At least 98% of the initial tacrolimus concentrations remained in all suspensions throughout the study period. Color, order, and pH did not change appreciably over the study period. Tacrolimus 0.5 mg/mL compounded extemporaneously in equal amounts of Ora-Plus and Simple Syrup, NF, was stable at 24-26 degrees C for at least 56 days in both glass and plastic amber prescription bottles.

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