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Stability of morphine sulfate in portable pump reservoirs during storage and simulated administration
M L Stiles1, Y H Tu, L V Allen
1College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City.
Abstract:
The stability of four concentrations of morphine sulfate injection in prefilled reservoirs for portable infusion pumps was studied after storage for 30 days at refrigerated and room temperature and after a three-day simulated administration period at body temperature. Thirty-milliliter samples of morphine sulfate injections in four concentrations--1, 5, 15, and 25 mg/mL--were loaded into a pump reservoir. The reservoirs were stored in the dark at 5 degrees C and 25 degrees C for 30 days. Samples were taken from each reservoir immediately after loading and after 7, 14, and 30 days of storage. The reservoirs were then connected to portable infusion pumps, which were run for three days at a flow rate of 0.4 mL/hr at 37 degrees C. The last sample was collected at the end of the three-day period. Samples were assayed for morphine sulfate content by high-performance liquid chromatography. The concentration of morphine sulfate increased up to 6% (for the 5-mg/mL sample) at refrigerated temperature and up to 16% (for the 15-mg/mL sample) at room temperature after 30 days' storage in the reservoirs. Evaporation of water from the reservoirs may have accounted for this phenomenon. No absolute relationship was found between the initial concentration of morphine sulfate and the percentage concentration increase after storage for 30 days. The change in morphine sulfate concentration before and after the three-day pumping period was not significant. Injectable solutions of morphine sulfate in concentrations ranging from 1 to 25 mg/mL are stable when stored at refrigerated temperature for 30 days in a prefilled drug reservoir.
Insights
Morphine sulfate injection stability was assessed in portable pump reservoirs. Solutions up to 25 mg/mL remained stable for 30 days under refrigeration, indicating suitability for patient use.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Pharmacokinetics
Background:
- Portable infusion pumps are crucial for continuous drug delivery.
- Ensuring the stability of injectable medications in prefilled reservoirs is vital for patient safety and therapeutic efficacy.
Purpose of the Study:
- To evaluate the stability of morphine sulfate injection in prefilled reservoirs for portable infusion pumps.
- To determine the impact of storage conditions (refrigerated and room temperature) and simulated administration on drug concentration.
Main Methods:
- Four concentrations of morphine sulfate (1, 5, 15, 25 mg/mL) were stored in prefilled reservoirs for 30 days at 5°C and 25°C.
- Samples were analyzed for morphine sulfate content using high-performance liquid chromatography at various time points.
- Reservoirs underwent a three-day simulated administration at 37°C.
Main Results:
- Morphine sulfate concentration increased slightly (up to 16%) after 30 days of storage, potentially due to water evaporation.
- No significant concentration changes were observed after the three-day simulated administration period.
- The drug demonstrated stability across tested concentrations and storage conditions.
Conclusions:
- Morphine sulfate injection (1-25 mg/mL) is stable in prefilled reservoirs for 30 days when stored under refrigeration.
- The findings support the use of these prefilled reservoirs for morphine sulfate in portable infusion systems.