Formulation, Stability, and Administration of Parenteral Nutrition With New Lipid Emulsions

Abstract

Intravenous lipid emulsions (IVLE) are an important source of energy and essential fatty acids and their incorporation into pediatric and adult parenteral nutrition (PN) regimens has revolutionized nutrition therapy. However, their clinical use has not been without risk, and will continue to remain so because of the intravenous route of administration. Pharmaceutical and microbiological concerns are centered around the methods of compounding all-in-one (AIO) admixtures, but these can be largely minimized with today's technologies and advanced understanding of aseptic principles. Modern lipid products, based on olive, coconut, and/or fish oils, have demonstrable formulation and clinical benefits over traditional soybean and safflower IVLE and, when combined in the new multi-chamber bags, can also offer improvements in stability and safety. This review outlines the rationale for different lipid formulations in PN admixtures, reviews the factors influencing stability and efficacy of lipid-based AIO regimens and evaluates some technologies for minimizing peroxidation and maximizing stability of AIO admixtures.

Immunomodulatory and physical effects of oil composition in vaccine adjuvant emulsions

“…Squalene is a linear triterpene available at high purity (≥98%). Grapeseed, sesame, and soybean oils are long-chain triglycerides (LCTs) containing a mixture of fatty acid components as well as phytosterols and tocopherols [20, 21]. USP monographs for sesame and soybean oils are available, and grapeseed oil provides a different triglyceride composition and source for comparison.…”

“…The question of molecular homogeneity as well as presence of undefined contaminants is especially important given historical and recent findings concerning both adjuvant activity and toxicity due to uncontrolled contaminants: first, the toxicity of IFA was considerably reduced due to purer materials and more refined emulsions [28]; second, regulatory requirements that more purified components be used in Adjuvant 65 resulted in loss of potency and caused an end of product development [29]; third, the w/o emulsion Montanide ISA 51 recently switched emulsifier source from animal to plant, which may be the cause of significantly reduced potency in clinical trials [30]. Moreover, plant-based oils contain various components besides triglycerides, such as phytosterols and α-tocopherol, [20]; the latter has shown adjuvant activity as an emulsion oil [31, 32]. Several drug-containing emulsions or other oil-based products are available commercially, including castor oil, cottonseed oil, MCTs, LCTs (e.g.…”

Lipids for parenteral nutrition in neonates

“…In adults, all-in-one (AIO) parenteral nutrition delivery was introduced in the 1970s [15]. Considering specific requirements of parenteral nutrition and lipid emulsion in neonates which include high requirement of calcium, magnesium and phosphates for bone mineralization and a relatively low pH of amino acid solutions, there remains concern about stability of AIO mixtures in this population [16 ]. However lipid administration as AIO can offer potential benefits including greater convenience, reduced risk of infection and lower pharmacy costs.…”

A.S.P.E.N. Clinical Guidelines

“…The stability of the TNA is also dependent on the container and storage conditions including light exposure and temperature. 63,[69][70][71] Careful attention to detail is necessary when trying to extrapolate study findings to the stability of a specific TNA. In the study by Driscoll et al, 45 different TNA admixtures were evaluated with final concentrations of monohydrated dextrose ranging from 5% to 20%, amino acids ranging from 2.5% to 7%, and injectable lipid emulsions ranging from 2% to 5%.…”

“…Driscoll et al evaluated the physicochemical stability of TNAs prepared with an IVFE made from both medium-chain and long-chain triglycerides, which produced more stable TNAs than long-chain triglycerides. 70,80 The safety of providing TNAs encompasses more than the stability of the formulation. Prolonged storage and/or light exposure may result in degradation or bioavailability of some components, especially vitamins.…”