PURPOSE: The physical and chemical stability of repackaged acetylcysteine 600 mg/3 mL solution in oral syringes stored under refrigeration or at room temperature was studied for six months; a cost analysis was also conducted. METHODS: Acetylcysteine 20% solution for inhalation was repackaged undiluted as 600 mg/3 mL in capped oral syringes and stored either under refrigeration or at room temperature exposed to fluorescent light. Four samples for each storage condition were analyzed in duplicate on day zero, weekly for the first month, and then every two weeks during months 2-6. Physical stability was assessed, and the chemical stability of acetylcysteine was evaluated by high-performance liquid chromatography. RESULTS: Acetylcysteine solution in syringes was physically stable during the entire six-month study period. When stored at room temperature, acetylcysteine retained 99% of the original concentration at three months and 95% at six months after preparation of the syringes. Loss of acetylcysteine was <2% at six months when stored under refrigeration. Packaging acetylcysteine in batches of 100 syringes instead of preparing individual syringes reduced wastage to zero syringes, saving an estimated $247 in drug costs. The estimated pharmacy time savings was 30 hours ($702). CONCLUSION: Acetylcysteine 20% solution repackaged as 600 mg/3 mL in oral syringes is both physically and chemically stable under refrigeration or at room temperature under normal fluorescent lighting for six months. The total loss of acetylcysteine was approximately 5% at room temperature under fluorescent lighting and <2% under refrigeration. Repackaging the solution in syringes in bulk rather than in single doses demonstrated a measurable cost saving.
PURPOSE: The physical and chemical stability of repackaged acetylcysteine 600 mg/3 mL solution in oral syringes stored under refrigeration or at room temperature was studied for six months; a cost analysis was also conducted. METHODS:Acetylcysteine 20% solution for inhalation was repackaged undiluted as 600 mg/3 mL in capped oral syringes and stored either under refrigeration or at room temperature exposed to fluorescent light. Four samples for each storage condition were analyzed in duplicate on day zero, weekly for the first month, and then every two weeks during months 2-6. Physical stability was assessed, and the chemical stability of acetylcysteine was evaluated by high-performance liquid chromatography. RESULTS:Acetylcysteine solution in syringes was physically stable during the entire six-month study period. When stored at room temperature, acetylcysteine retained 99% of the original concentration at three months and 95% at six months after preparation of the syringes. Loss of acetylcysteine was <2% at six months when stored under refrigeration. Packaging acetylcysteine in batches of 100 syringes instead of preparing individual syringes reduced wastage to zero syringes, saving an estimated $247 in drug costs. The estimated pharmacy time savings was 30 hours ($702). CONCLUSION:Acetylcysteine 20% solution repackaged as 600 mg/3 mL in oral syringes is both physically and chemically stable under refrigeration or at room temperature under normal fluorescent lighting for six months. The total loss of acetylcysteine was approximately 5% at room temperature under fluorescent lighting and <2% under refrigeration. Repackaging the solution in syringes in bulk rather than in single doses demonstrated a measurable cost saving.