Stability of lipid emulsion in total parenteral nutrition: An overview of literature

Otero-Millán, Luis; Rivero, Natividad Lago; Rodicio, Antía Blanco; Beloso, N García; Soto, José Luis Legido; Piñeiro-Corrales, Guadalupe

doi:10.1016/j.clnesp.2021.06.027

Cited by 9 publications

(7 citation statements)

References 24 publications

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“…In stability studies, it is common to measure other properties of emulsions, such as the zeta potential. A zeta potential below −20 mV increases the attraction derived from Van der Waals forces over electrostatic repulsion [ 10 , 20 ]. This would lead to destabilization of the emulsion.…”

Section: Discussionmentioning

confidence: 99%

“…They are lipid emulsions with several components in solution: amino acids, phosphate salts, calcium, magnesium, sodium, potassium, vitamins, and trace elements (copper, zinc, manganese, etc.). For that reason, the physicochemical processes that can occur are very diverse and unpredictable [ 10 ], hence the difficulty in unequivocally determining their stability and safety [ 11 ]. One of the main physicochemical stability problems is the destabilization of the lipid emulsion.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Stability of Newborn Hospital Parenteral Nutrition Solutions

Otero-Millán,

Bea-Mascato,

Legido Soto

et al. 2024

Pharmaceutics

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(1) Background: parenteral nutrition (PN) solutions are an extremely complex mixture. It is composed of a multitude of chemical elements that can give rise to a large number of interactions that condition its stability and safety. The aim of this study was to evaluate the stability of PN solutions for preterm infants. (2) Methods: eight samples were prepared according to the protocol for prescribing PN in preterm infants. Samples PN1–PN7 had the normal progression of macronutrients and standard amounts of micronutrients for a 1 kg preterm infant. The PN8 sample had a high concentration of electrolytes, with the idea of forcing stability limits. Samples were stored both at room temperature and under refrigeration. Measurements of globule size, pH, density, and viscosity were performed in both storage protocols on different days after processing. (3) Results: the changes in the composition of the samples did not affect the evolution of the stability at the different measurement times and temperatures. Viscosity was affected by the compositional changes made in the PN samples, but no alterations due to time or temperature were observed. Density and pH remained stable, without significant changes due to time, storage temperature, or different composition. (4) Conclusion: all samples remained stable during the study period and did not undergo significant alterations due to compositional changes or different experimental conditions.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of the Stability of Newborn Hospital Parenteral Nutrition Solutions

Otero-Millán,

Bea-Mascato,

Legido Soto

et al. 2024

Pharmaceutics

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“…The physicochemical stability of a lipid emulsion is an important characteristic that depends on factors such as temperature, pH, exposure to light and oxygen, peroxidation, the presence of vitamins and trace elements, the presence and relative concentration of divalent ions, and the type of container [5]. Stability issues become more complex when amino acids, vitamins, trace elements, electrolytes, or carbohydrates are added for parenteral nutrition [6]. Both glass and plastic containers are generally suitable, and they maintain the physicochemical stability of lipid emulsions, although they may differ in their effect on the same product [7].…”

Section: Considerations For the Manufacturing Of Parenteral Lipid Emu...mentioning

confidence: 99%

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

Grumbach

Czermak

2022

Processes

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The good manufacturing practices (GMP) and process analytical technology (PAT) initiatives of the US Food and Drug Administration, in conjunction with International Council for Harmonisation (ICH) quality guidelines Q8, Q9, and Q10, ensure that manufacturing processes for parenteral formulations meet the requirements of increasingly strict regulations. This involves the selection of suitable process analytics for process integration and aseptic processing. In this article, we discuss the PAT requirements for the GMP-compliant manufacturing of parenteral lipid emulsions, which can be used for clinical nutrition or for the delivery of lipophilic active ingredients. There are risks associated with the manufacturing processes, including the potential for unstable emulsions and the formation of large droplets that can induce embolisms in the patient. Parenteral emulsions are currently monitored offline using a statistical approach. Inline analytics, supplemented by measurements of zeta potential, could minimize the above risks. Laser scanning technology, ultrasound attenuation spectroscopy, and photo-optical sensors combined with image analysis may prove to be useful PAT methods. In the future, these technologies could lead to better process understanding and control, thus improving production efficiency.

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“…Moreover, establishing an appropriate method for analysing total parenteral nutrition (TPN) products, administered mostly for critically ill patients is crucial due to the chemical complexity of its components, particularly in lipid content. 1,2 For instance, analytical techniques in analysing fatty acids (FAs) in food and pharmaceutical products has evolved through the recent years from using gas chromatography-ame a Department of Chemistry -Biomedical Center, Analytical Chemistry and Neurochemistry, Uppsala University, Uppsala, Sweden. E-mail: mark.retrato@ kemi.uu.se b Innovation and Development Department, Fresenius-Kabi, Uppsala, Sweden c Swedish Food Agency (Livsmedelsverket), Uppsala, Sweden † Electronic supplementary information (ESI) available: Workow of GC-MS method development in analysing TPN components.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, establishing an appropriate method for analysing total parenteral nutrition (TPN) products, administered mostly for critically ill patients is crucial due to the chemical complexity of its components, particularly in lipid content. 1,2 For instance, analytical techniques in analysing fatty acids (FAs) in food and pharmaceutical products has evolved through the recent years from using gas chromatography-flame ionization detector (GC-FID) methods 3–9 to gas chromatography-mass spectrometry (GC-MS) methods 10–19 due to the higher sensitivity of the MS detectors, 20,21 giving a better estimate of FAs present in the analyte of interest.…”

Section: Introductionmentioning

confidence: 99%