Background Levosimendan (Simdax) is a calcium sensitizer that is effective in the treatment of heart failure. The available vials contain an adult dose but levosimendan is also used as off-label treatment in children.
Aseptic preparation of low doses of levosimendan could save money. We had already demonstrated the chemical stability of levosimendan. Because preparations in syringes, especially of more volatile and lipophilic solutions are problematic, we focused in our new study on compounds that might leach out of polypropylene syringes. A syringe is not a totally closed system for volatile solvents and the risk of leachables is higher with lipophilic solvents.
Purpose To investigate substances leached out of syringes of low-dose levosimendan during storage.
Materials and methods The stability of 1 ml levosimendan syringes stored at 8°C was tested over 2 months with focus on leachables and loss of solvent. The HPLC method for levosimendan was validated by stress tests and separated out three main degradation products under alkaline conditions. Another HPLC method was validated to detect leachables. A new source of Simdax was also tested in the present study.
Results We were able to confirm our previous results about the chemical stability with the new batch of Simdax. After 2 months a significant amount of leachables could be detected in the samples prepared in 1 ml syringes. The relevance of these leachables needs further investigation.
Conclusions If the aseptic preparation is microbiologically validated, it will be possible to prepare paediatric doses of levosimendan in the pharmacy. The preparations are stable for 2 months if they are stored at 8°C. This will make child treatment with levosimendan less expensive. Because of detectable leachables in the syringes, special care needs to be taken in the choice of containers.
No conflict of interest.
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