Stability of total nutrient admixtures with lipid injectable emulsions in glass versus plastic packaging

Abstract

Certain lipid injectable emulsions packaged in plastic containers have baseline abnormal GSD profiles compared with those packaged in glass containers. When used to compound TNAs, the abnormal profile worsens and produces less stable TNAs than those compounded with lipid injectable emulsions packaged in glass containers.

Stability of MCT/LCT‐Based Total Nutrient Admixtures for Neonatal Use Over 30 Hours at Room Temperature

“…In fact, the newly adopted USP monograph titled "Lipid Injectable Emulsion" 32 specifies a pH range between 6.0 and 9.0, yet not one of the neonatal TNAs fell within this range. In fact, acidic TNAs (pH < 6.0) are commonly found in many such admixtures in adults, 4,33 in addition to the more profound pH levels seen in neonatal TNAs here and previously. 25 Moreover, it is not advisable to attempt to elevate the final pH of PN formulations, as admixtures with pH >6.4 carry a high risk of producing potential harmful calcium-phosphate incompatibilities.…”

Droplet-size distribution and stability of lipid injectable emulsions

“…1 This upper limit takes into account both emulsion stability issues and probable occurrence of embolic occlusions. 29,30 In this regard, Driscoll et al 31,32 recently reported that native lipid emulsions packaged in plastic containers and exceeding the PFAT 5 limit produce less-stable total nutrient admixtures compared with those packaged in conventional glass, which do meet proposed USP standards.…”

Lipid globule size in total nutrient admixtures prepared in three-chamber plastic bags

“…3,6 We have also shown that the lipid formulations exceeding the PFAT 5 limits of USP chapter 729 not only contain an inordinate number of potentially embolic fat globules but that such coarsening of the GSD has also been associated with instability when used under two common clinical conditions: (1) TNAs 6 and (2) aseptic transfer of native 20% emulsion to a syringe for delivery in critically ill premature infants. 7 In this present study, a third common clinical use condition of lipids for parenteral nutrition support as delivered via 3CP bags was investigated.…”