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The stability of new generation intravenous lipid emulsions

King, Helen Mary 2019. The stability of new generation intravenous lipid emulsions. PhD Thesis, Cardiff University.
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Intravenous lipid emulsions (IVLE’s) form a staple part of parenteral nutrition (PN). PN provides life sustaining support where gastrointestinal nutrition is inadequate due to disease or prematurity. Whilst the physical stability of IVLE’s is relatively well known and quantified, chemical stability is an area where little testing has occurred. Lipids are susceptible to breakdown through free radical attack leading to lipid peroxidation, a cyclical process resulting in the production of primary and secondary toxic lipid peroxidation products. This thesis presents the development and validation of a method for measurement of peroxidation and triglyceride (TAG) breakdown occurring within two intravenous lipid emulsions. The high-performance liquid chromatography (HPLC) method developed uses in-line ultra-violet (UV) and charged aerosol detection (CAD) to monitor the six main TAGs in Intralipid® emulsion and 10 TAGs in SMOFlipid® and detects the toxic secondary peroxidation products 4-Hydroxynonenal (HNE) and Hydroxyundecenal (HUE). The assay was validated in line and employed to test the chemical stability the established lipid emulsion (Intralipid®) and a newer lipid emulsion (SMOFlipid®). Both lipids were subject to up to 84 days storage within 50 ml syringes, 250 ml PN bags and 50 ml glass vials at room and fridge temperatures. The effect of light exposure was tested using light protected and non-light protected samples of each lipid. Results within each chapter detail the extensive levels of TAG losses observed within each container and the detection of secondary peroxidation products. Fridge temperature limited TAG loss and peroxidation in all containers, however secondary peroxidation products were detected. Both SMOFlipid® and Intralipid® gave in excess of 30 % losses in TAGs over 84 days storage. HNE, HUE and a triglyceride remnant were all recorded in SMOFlipid® and Intralipid® syringes (both temperatures) and small volume PN bags at room temperature. Light protection within this study showed no significant difference vs non-light protection. The results obtained from the work within this thesis are of vital importance when considering the safety of lipid emulsions for intravenous nutrition. This work provides an initial data set on the levels of peroxidation occurring within two commercially available in-use lipid emulsions and highlights the necessity for the stability and storage limits of these emulsions to be re-assessed.

Item Type: Thesis (PhD)
Date Type: Completion
Status: Unpublished
Schools: Pharmacy
Subjects: Q Science > Q Science (General)
Uncontrolled Keywords: lipids, peroxidation, parenteral nutrition, HPLC, triglycerides, 4-hydroxynonenal
Date of First Compliant Deposit: 16 May 2019
Last Modified: 16 May 2019 09:03

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