The Study on the Stability of Mannitol Solution

Abstract

Background: Mannitol, an osmotic diuretic is used to reduce side effects of cisplatin, an anticancer drug. Mannitol injection is diluted to different concentrations before use, but no study conducted in Thailand concerning its physical and chemical stability and sterility after preparation.

Objectives: To study the contributing factors upon physical stability of 5, 10, 15 and 20% w/v mannitol solution in normal saline solution (NSS). In addition, physical and chemical stability and sterility of the 10% w/v mannitol solution in NSS were studied.

Method: A 2-phase study was conducted. In the first phase, the contributing factors that influence the physical stability of 5, 10, 15 and 20% w/v mannitol solution in NSS kept at 2–8 degrees Celsius (°C), and at 30±2 °C, with relative humidity (RH) 75±5% on day 0, 3, 7, and 14 after preparation were investigated. In the second phase, the physical and chemical stability, and sterility of 10% w/v mannitol solution in NSS were examined in the same conditions as in the first phase of study.

Results: The first phase of study revealed no apparent physical changes among 5, 10 and 15% w/v mannitol solution in NSS, kept at 2 –8 °C and 30±2 °C, with RH 75±5%. However, visible precipitation was observed in 20% w/v mannitol solution in NSS, kept at 2–8 °C from the third day onward, while there was no change in 20% w/v mannitol solution in NSS kept at 30±2 °C. In the second phase of study, 10% w/v mannitol solution in NSS presented physical and chemical stability, and sterility throughout the study period of 14 days. The pH of the solutions were 4.5–7.0, % label amount were 95–105%. No growth of any bacteria or fungi was found within the study period.

Conclusion: The contributing factors to the physical stability of mannitol solution in NSS are the concentration of the solution, and storage temperature. Higher concentration along with lower temperature both increase the probability of precipitation. The 10% w/v mannitol solution in NSS possesses physical and chemical stability, and sterility kept at 2–8 °C and 30±2 °C, RH 75±5% for at least 14 days.