Physical and Chemical Stability of Treprostinil Sodium Injection Packaged in Plastic Syringe pump Reservoirs.

The objective of this study was to evaluate the physical and chemical stability of treprostinil (as sodium) injections in concentrations of 1, 2.5, 5 and 10 mg/mL packaged in MiniMed plastic syringe pump reservoirs. Test samples of treprostinil (as sodium) injections having concentrations of 1, 2.5, 5, and 10 mg/mL were packaged as 3 mL of drug solution in 3-mL MiniMed plastic syringe pump reservoirs, sealed with plastic tip caps and stored at -20 deg C, 4 deg C, 23 deg C and 37 deg C for 60 days. Evaluations for physical and chemical stability were performed initially and throughout the storage periods. Physical stability was assessed using visual observation in normal room light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drug was evaluated by using a stability-indicating high-performance liquid chromatographic analytical technique. All samples of treprostinil (as sodium) injection remained free of visible precipitation throughout the study. Little or no change in haze level and in particulates of greater than or equal to 10 micrometers was found. Changes in treprostinil concentration were found to be small; treprostinil sodium concentrations were found to be 95% or greater over 60 days at all temperatures studied. Treprostinil (as sodium) injections at concentrations ranging from 1 to 10 mg/mL can be packaged in MiniMed plastic syringe reservoirs, stored and shipped with little or no loss of drug stability.