PFAT5 and the Evolution of Lipid Admixture Stability.

Abstract

PFAT5 is defined by United States Pharmacopeia Chapter 729 as follows: the "percentage of fat residing in globules larger than 5 µm (PFAT5) for a given lipid injectable emulsion [is] not to exceed 0.05%." The unstable aggregates are trapped in lungs, liver, and the reticuloendothelial system. Large particles will accumulate in pulmonary capillaries, which are between 4 and 9 µm in diameter. Over the years, there has been an evolution of methods to characterize and define intravenous fat emulsion (IVFE) stability when combined as a total nutrient admixture (TNA). Many studies have claimed IVFE stability measuring mean particle size, zeta potential, and visual checks. Interestingly, none of the studies that claimed the TNA as stable identified an unstable one through testing. This report reviews those parameters and shows they were not a valid measure of lipid stability. The PFAT5 parameter has emerged as the only validated measure of lipid stability. There are clinical consequences of using lipids that exceed the PFAT5 limit. This parameter is applicable to both manufactured and compounded lipid preparations. The clinician should be aware of the limitations of much of the literature concerning the lipid stability assessment. More stability studies are needed using PFAT5 to identify the actual limits of TNA compounding.