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Stability of aminophylline.
Pakistan Journal of Pharmaceutical Sciences
|January 1, 1993
Summary
Aminophylline stability is compromised by heat, sunlight, glucose, and lactose, leading to degradation and color change. It remains stable in most intravenous fluids for two days, with exceptions noted for specific solutions at higher temperatures.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Formulation Science
Background:
- Aminophylline is a common bronchodilator.
- Understanding its stability is crucial for safe and effective administration.
- Excipients and intravenous fluids can impact drug degradation.
Purpose of the Study:
- To evaluate the stability of aminophylline.
- To assess its compatibility with common tablet excipients.
- To determine its stability and compatibility in various intravenous fluids.
Main Methods:
- Aminophylline mixtures (10%) with excipients (cellulose starch, glucose, lactose) were stored for 30 days at varying temperatures (5°C, room temp, 45°C) and sunlight exposure.
- Aminophylline solutions (1 g/L) were tested for stability and compatibility in nine intravenous fluids under different temperature conditions.
- Degradation and color changes were monitored.
Main Results:
- Aminophylline degradation increased with temperature and sunlight exposure.
- Glucose and lactose significantly accelerated aminophylline degradation, causing a yellow discoloration.
- Aminophylline was stable in most IV fluids for 2 days, except in Lipofundin 10% and TPNS, where stability was limited to 12 hours at 45°C. Dextrose-containing admixtures showed yellowing.
Conclusions:
- Aminophylline stability is sensitive to temperature, light, and specific excipients like glucose and lactose.
- Careful consideration of storage conditions and co-administered intravenous fluids is necessary for aminophylline.
- Potential for degradation and discoloration exists, particularly with dextrose-containing solutions and under adverse conditions.