Stability of tacrolimus injection diluted in 0.9% sodium chloride injection and stored in Excel bags

Abstract

Extemporaneously prepared infusion solutions of tacrolimus 2, 4, and 8 μg/mL in 0.9% sodium chloride injection in Excel bags were chemically and physically stable for at least nine days when stored at room temperature (23 °C) without protection from light and when stored in a refrigerator (4 °C) in the dark.

Interdisciplinary implementation of tacrolimus intravenous standard concentration in hematopoietic stem cell transplantation recipients

“…Following acquisition of our novel stability data, the pilot phase was then instituted from 1 April 2015 to 30 June 2015, during which patients received tacrolimus IV standard concentration (Figure 2). 7 Patients were included if they received IV tacrolimus on the pilot unit during the study inclusion period. Patients were no longer followed after the patient was switched to oral tacrolimus or transferred off the pilot units (i.e., ICU or other unit).…”

“…Our previous physico-chemical stability studies showed that tacrolimus admixtures prepared in NS in Excel® bags (B. Braun Medical Inc., Bethlehem, PA), at concentrations of 2, 4, and 8 µg/mL, were chemically and physically stable for at least 9 days when stored at room temperature (23℃) without protection from light, and at least 9 days when stored in the refrigerator (4℃) in the dark. 7 Thus, the beyond use date (BUD) of tacrolimus IV standard concentration was 9 days under refrigeration. 7,9 The BUD was not implemented until 1 May 2015 after the stability study results were available and batching began.…”

“…1 New stability data was recently published for extemporaneously prepared tacrolimus infusion solution in 0.9% sodium chloride injection in Excel bags was stable for at least 9 days at room temperature or in the refrigerator. 7 Due to adsorption to polyvinyl chloride (PVC) packaging material, tacrolimus must be prepared in non-PVC bags and infused through non-PVC tubing, which cost 4.4-fold more than standard tubing. 8 Each time the tacrolimus dose is changed the concentration of the infusion solution changes, requiring tubing replacement and priming which is also an added cost in supplies and additional drug.…”

“…The purpose was to apply newly studied tacrolimus stability data with reference stability data from the manufacturer and to compare the quantitative reduction of waste and cost with using standardized concentration of IV tacrolimus. 7…”

A Comprehensive Strategy to Evaluate Compatible Stability of Chinese Medicine Injection and Infusion Solutions Based on Chemical Analysis and Bioactivity Assay

“…The importance of compatible stability of chemical medicine injections and infusion solutions have been reported in many studies ( Binnor et al, 2013 ; Chen et al, 2015a , b ; Myers et al, 2016 ). As chemical medicine injections generally contain only single active component, the change of single active component can represent the change of injection stability.…”