Short-term stability of diluted treprostinil sodium for subcutaneous administration
Sketch, M. R.; Sauerstrom, D.; Lange, A. M.; Diehl, J.
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BackgroundThe Remunity Pump for Remodulin (treprostinil) Injection is an infusion system indicated for use with subcutaneous treprostinil. ObjectiveThe objective was to assess the stability of diluted treprostinil sodium stored in Remunity pump cassettes. MethodsTreprostinils chemical and physical stability were assessed over a 76-hour period at 40 degrees Celsius and 75% relative humidity after dilution to 0.01 mg/mL in sterile water for injection and 0.9% sodium chloride. Analyses were conducted via visual inspection, pH measurement, and a stability-indicating high-performance liquid chromatographic assay. ResultsAt all time points, the treprostinil samples were consistently clear, colorless, and free of visible particulate matter, with pH levels 6.0-7.0. All assays were within 90.0%-110.0% of the label claim, with minimal variation. ConclusionsTreprostinil diluted to 0.01 mg/mL was stable in Remunity pump cassettes for up to 76 hours at elevated temperature and humidity. No notable changes from label claim concentration values were observed.
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