Stability of Tacrolimus Injection in Total Parenteral Nutrition Solution

Abstract

Objective:

To examine the stability of tacrolimus in a total parenteral nutrition (TPN) solution over 24 hours at room temperature.

Study Method:

Admixtures of tacrolimus 0.1 mg/mL in TPN, containing amino acids 4.25%, dextrose 25%, and electrolytes, were prepared and visually inspected under normal lighting conditions against a white and black background for color change, turbidity, cloudiness, and precipitation. The concentration of tacrolimus in the admixtures was determined by HPLC at 0, 1, 2, 4, 8, 12, and 24 hours after preparation.

Results:

The concentration of tacrolimus did not change over the 24-hour study period. No color change, precipitation, or cloudiness was observed in any of the solutions under the storage conditions.

Conclusions:

Tacrolimus is chemically stable in TPN for 24 hours at room temperature, and therefore can be administered to patients as a 24-hour continuous infusion with TPN.