Physicochemical stability of sufentanil citrate in Rythmic^TM administration set reservoirs or in a polyolefin infusion bag diluted in 0.9% sodium chloride or in 5% dextrose at 1 and 10 µg/mL stored at 20-25°C protected from light

Background
Sufentanil citrate is an opioid analgesic widely used in clinical practice. Studies have shown the high capacity of interactions between sufentanil in solution and plastic components in parental delivery systems that is mainly due to an absorption onto surfaces containing polyvinylchloride (PVC) with bis(2-ethylhexyl) phthalate (DEHP) or polypropylene (PP). However, no studies were done on sufentanil solutions in Rythmic^TM administration set reservoir bag made from polyvinyl chloride (PVC) without DEHP.

Objectives
The aim of this study was to assess the physicochemical stability of sufentanil citrate in Rythmic^TM Administration set 200 mL reservoirs and in polyolefin infusion (IV) bag diluted in 0.9% sodium chloride (0.9% NaCl) or in 5% dextrose (D5W) at 1 and 10 µg/mL stored at 20-25°C, protected from light.

Materials and methods
Test solutions were prepared in polyolefin IV bags and in Rythmic^TM reservoirs in 0.9% NaCl and D5W at 1 and 10 µg/mL. Three preparations were done for each condition. They were stored at room temperature, protected from light. At each analysis time, samples were tested by High Performance Liquid Chromatography coupled to a photodiode array detector. pH was also measured. Physical stability was evaluated by a visual and sub-visual inspection.

Results
Solutions of sufentanil of all tested conditions, except one, retained more than 90% of the initial concentration for 7 days at room temperature, protected from light. For the solutions at 1 µg/mL in 0.9% NaCl in Rythmic^TM reservoir the concentration decreased up to 14%. No physical changes were detected visually nor sub-visually. pH values remained stable.

Conclusion
Our study proves the physicochemical stability of sufentanil citrate solutions for 7 days at room temperature, protected from light, of all of the tested conditions except the solution at 1 µg/mL in 0.9% NaCl in Rythmic^TM reservoir bags. These results could be applied to our practice for preparation of sufentanil citrate solutions in our hospital pharmacy.

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