Abstract
All-in-one (AIO) admixtures for parenteral nutrition are common in hospital pharmacy practices. They are extemporaneously prepared and should be stable during preparation, storage, and administration. Lipid emulsion is a clinically important and very susceptible component of instability. The objective of study was to evaluate the long-term stability of AIO admixtures containing modern lipid emulsions. AIO admixtures with two different emulsions (SMOFlipid and Lipoplus) containing the same amount of glucose and complex amino acid solution, and variable amounts of ions were prepared. Samples were evaluated at 2, 5, 8 and 30 days after preparation. The main indicator of AIO system stability was the amount of lipid globules greater than 5 μm in diameter, which is limited by pharmacopoeia. Optical microscopy was used for particle size measurement. All prepared AIO admixtures remained stable during observation. The counts of overlimit lipid particles were within pharmacopeial limit nevertheless tended to increase in time. After 30-day storage, their value was influenced mainly by concentration of calcium ions, which at lower concentrations had a greater impact on SMOFlipid-based admixtures, whereas at the highest concentration on Lipoplus-based admixtures. The concentration of ions and osmolarity remained without changes; pH of admixtures slightly decreased. Both lipid emulsions were found to be suitable for preparation AIO admixtures with different concentrations of electrolytes. The formulations were stable even if contained high concentrations of divalent ions. The comparison of emulsions revealed the superiority of Lipoplus - electrolyte concentrations and duration of storage had a greater impact on admixtures with SMOFlipid.
Highlights
All-in-one (AIO) admixtures, known as total parenteral nutrition (TPN) or total nutrient admixtures, are parenteral nutrition (PN) formulations containing water, glucose, amino acids, lipids, electrolytes, trace elements, and vitamins in a single container [1]
Both lipid emulsions were found to be suitable for preparation AIO admixtures with different concentrations of electrolytes
The first generation is represented by conventional lipid emulsions based on soybean and/or safflower oil, very rich in ω-6 polyunsaturated fatty acids (PUFAs) [6]
Summary
All-in-one (AIO) admixtures, known as total parenteral nutrition (TPN) or total nutrient admixtures, are parenteral nutrition (PN) formulations containing water, glucose (dextrose), amino acids, lipids, electrolytes, trace elements, and vitamins in a single container [1]. Lipid emulsions belong to the main constituents of these admixtures They are a valuable source of energy and essential fatty acids, and may act as an effective modulator of the immune system [2,3,4] and inflammatory responses [4, 5]. The first generation is represented by conventional lipid emulsions based on soybean and/or safflower oil, very rich in ω-6 polyunsaturated fatty acids (PUFAs) [6]. Due to their side effects – they may be associated with increased rates of infection and lipid peroxidation, which can exacerbate oxidative stress [4] – new emulsions were developed. The second-generation parenteral lipid emulsions, respecting the potential disadvantageous
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