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PFAT5 and the Evolution of Lipid Admixture Stability
1Memorial Sloan Kettering Cancer Center, New York, New York klangm@mskcc.org.
JPEN. Journal of Parenteral and Enteral Nutrition
|July 17, 2015
Summary
The percentage of fat larger than 5 µm (PFAT5) is the only validated measure for lipid injectable emulsion stability. Previous methods like particle size are unreliable, and exceeding the PFAT5 limit has clinical consequences.
Area of Science:
- Parenteral nutrition
- Lipid emulsion stability
- Pharmacopeial standards
Background:
- Intravenous fat emulsions (IVFEs) are crucial in total nutrient admixtures (TNAs).
- Assessing IVFE stability in TNAs is critical for patient safety.
- Traditional methods for assessing lipid stability lack validation.
Purpose of the Study:
- To review traditional methods for assessing IVFE stability in TNAs.
- To highlight the limitations of current stability assessment parameters.
- To establish the percentage of fat larger than 5 µm (PFAT5) as the validated measure of lipid stability.
Main Methods:
- Review of existing literature on IVFE stability assessment.
- Analysis of traditional parameters: mean particle size, zeta potential, and visual checks.
- Emphasis on the United States Pharmacopeia Chapter 729 definition of PFAT5.
Main Results:
- Traditional methods (particle size, zeta potential, visual checks) are not valid measures of lipid stability.
- The PFAT5 parameter is the only validated method for assessing lipid stability.
- Exceeding the PFAT5 limit (0.05%) can lead to accumulation of unstable aggregates in organs.
Conclusions:
- Clinicians must be aware of the limitations in current literature regarding lipid stability assessment.
- PFAT5 is applicable to both manufactured and compounded lipid preparations.
- Further research using PFAT5 is needed to define the actual limits of TNA compounding.
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