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Development of analytical methods for the stability assessment of parenteral nutrition

Emery, Sophie 2018. Development of analytical methods for the stability assessment of parenteral nutrition. PhD Thesis, Cardiff University.
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Abstract

Parenteral nutrition (PN) provides intravenous nutritional support to patients with reduced gastrointestinal function. A PN bag comprises the basic building blocks of the food groups: lipids, glucose, amino acids, vitamins, electrolytes and trace elements. Recently there has been an increase in demand for extended storage periods for PN bags, to ease management of an increasing home care market. Prior to a PN formulation being deemed safe for a patient, a laboratory simulation is carried out on the proposed admixture under the requested storage and administration conditions. Currently only the physical stability is assessed; physical testing provides no information on the quantity of each component remaining in the bag after storage. Consequently, there is a need for assessing the chemical stability of PN to indicate the quantity of each component that remains in the PN bag. A commonly used amino acid product, Aminoven® 25, contains 16 amino acids; this work aimed to develop a HPLC assay capable of quantifying the amino acids in an aqueous PN bag containing Aminoven® 25. Fluorescence detection was used as it is a highly selective method of detection, which was preferable due to the number of components in PN. To detect the amino acids, as they don’t naturally fluoresce, derivatization was carried out using ortho-phthalaldehyde to form a fluorescing derivative. The developed assay resulted in validation of thirteen of the amino acids in Aminoven® 25. In addition, the method was shown to be unaffected by the iv presence of aqueous PN components, so this method is suitable for quantifying thirteen amino acids in aqueous PN containing Aminoven® 25. This assay can be used for assessing the stability during stability testing and confirming the quantity of amino acids after compounding for quality control release.

Item Type: Thesis (PhD)
Date Type: Completion
Status: Unpublished
Schools: Pharmacy
Subjects: R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Date of First Compliant Deposit: 11 June 2018
Last Modified: 11 Jun 2018 13:45
URI: http://orca-mwe.cf.ac.uk/id/eprint/112136

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