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Emulsion stability in a total nutrient admixture for total parenteral nutrition
M Deitel1, K L Friedman, S Cunnane
1Department of Surgery, University of Toronto, St. Joseph's Health Centre, Canada.
Journal of the American College of Nutrition
|February 1, 1992
Summary
Total parenteral nutrition (TPN) lipid emulsions remain stable for 28 days refrigerated, followed by 2 days at room temperature. This stability is crucial for safe and effective TPN therapy.
Area of Science:
- Nutritional Science
- Pharmaceutical Stability
- Biochemistry
Background:
- Parenteral nutrition is essential for patients unable to consume food orally.
- Lipid emulsions are a critical component of parenteral nutrition, providing essential fatty acids and calories.
- Ensuring the stability of lipid emulsions in total nutrient admixtures (TNA) is vital for patient safety and therapeutic efficacy.
Purpose of the Study:
- To assess the emulsion stability of a total nutrient admixture (TNA) containing lipid.
- To evaluate the stability of TNA under prolonged refrigerated storage followed by room temperature exposure.
- To determine the impact of storage conditions on particle size, pH, osmolality, and fatty acid profile.
Main Methods:
- Total parenteral nutrition (TPN) solutions containing lipid were stored at 4°C for up to 28 days, followed by 2 days at 22°C.
- Stability was assessed using direct observation, light and electron microscopy, Coulter counter analysis, pH and osmolality measurements, and fatty acid profiling.
- Samples were analyzed at various time points, including initial, after 2 days at room temperature, and after prolonged refrigeration with subsequent room temperature exposure.
Main Results:
- Light microscopy showed no increase in particles greater than 2 microns.
- Electron microscopy indicated a slight increase in lipid particle size up to 30 days (mean diameter 0.36 ± 0.01 micron).
- Coulter counter studies revealed an increase in lipid droplet diameter at room temperature, but 99% of particles remained under 1.97 microns.
- pH (6.35 ± 0.04) and osmolality (1880 ± 14.5 mOsm/kg) remained constant.
- Fatty acid profiles, including triglyceride, phospholipid, and total lipid amounts, showed no significant changes.
Conclusions:
- The lipid emulsion in the tested total nutrient admixture (TNA) demonstrated stability.
- The TNA remained stable throughout 28 days of refrigeration followed by 2 days at room temperature.
- These findings support the safe use and storage of this TPN formulation under the tested conditions.