Physicochemical Stability and Sterility of Standard Parenteral Nutrition Solutions and Simulated Y‐Site Admixtures for Neonates

Riera, Pau; GarridoAlejos, G.; Cardenete, Joana; Moliner, Ernesto Clar; Zapico‐Muñiz, Edgar; Cardona, Daniel; Garin, Noé

doi:10.1002/ncp.10013

Cited by 11 publications

(6 citation statements)

References 18 publications

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“…However, we chose pH, the particle size of the lipid emulsions by DLS and LD techniques, and the zeta potential. Such methods were used for investigating the stability of TPN admixtures by Garcia et al [3], Mediavilla et al [4], and Riera et al [5]. These parameters can be used for a quick and easy assessment of the stability of lipid emulsions, such as TPN admixtures.…”

Section: Discussionmentioning

confidence: 99%

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Effect of Lipid Emulsion on Stability of Ampicillin in Total Parenteral Nutrition

et al. 2019

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Background: Ampicillin (AMP) is frequently administered parenterally in critically ill patients with meningitis or endocarditis. Many of them require parallel infusion of total parenteral nutrition (TPN) admixtures. The aim of the study was to determine the physicochemical stability of AMP in TPN admixtures. Methods: AMP was added to two formulations of TPN admixtures differing in the lipid emulsion (Lipofundin® MCT/LCT 20% or LIPIDem®). Samples were stored at 4 ± 1 °C with light protection, and at 25 ± 1 °C with and without light protection to assess the impact of temperature and light on formulation stability. Every 24 h the pH, zeta potential, mean droplet diameter (MDD) of a lipid emulsion, and AMP concentration using HPLC method were determined. The assessment of stability and compatibility of TPN admixtures with vitamins and trace elements was carried out immediately after preparation and after 24 h of storage. Results: The addition of AMP as well as vitamins and trace elements to the TPN admixtures did not affect their physical stability. An increase in the pH value of approx. 0.6 and reduction of zeta potential were observed. The MDD of the lipid emulsions was below the limit of 500 nm (dynamic light scattering (DLS) method) and no fat droplets greater than 525 nm were observed (light diffraction (LD) method). The content of AMP after the first 24 h was within the acceptable limit of 90% for TPN admixtures stored at 4 ± 1 °C and 25 ± 1 °C with light protection. Conclusions: The results showed that co-administration of AMP in the same bag with TPN admixture at the tested dose is possible when used ex tempore and with light protection.

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Section: Discussionmentioning

confidence: 99%

“…There are few reports in the literature regarding physicochemical compatibility and stability of TPN admixtures and IV drugs. However, in recent years this topic has attracted more attention [1,2,3,4,5]. Administration of a drug with unknown stability is a direct threat to a patient’s health and life.…”

Section: Introductionmentioning

confidence: 99%

Effect of Lipid Emulsion on Stability of Ampicillin in Total Parenteral Nutrition

et al. 2019

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“…The co-administration of drugs and TPN admixtures is an important clinical problem. In recent years, this subject is being increasingly undertaken, and the results that were obtained in those studies can be applied in clinical practice [3][4][5][6][7]. Most of the researchers undertake the problem of the compatibility of drugs with TPN admixtures to determine the possibility of their simultaneous administration via Y-site to the same vascular access.…”

Section: Introductionmentioning

confidence: 99%

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

et al. 2019

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Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated. Methods: An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 µm) with a C18 pre-column (LiChrospher 100, 4 mm, 5 µm). The flow rate was 1.0 mL min−1 and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up. Results: The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures. Conclusions: The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t0.5 varied from 142.44 h to 300.45 h).

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“…According to Staven et al [20], inadequate sensitivity of the Zetasizer nano ZS apparatus may not allow the detection of larger particles of lipid emulsion. Nevertheless, the measuring range of this apparatus is from 0.3 nm to 10 µm, and this method is still recommended by US Pharmacopeia [14] and used by other researchers [28][29][30]. Taking care of the highest quality of the test, to avoid errors related to the suggested lack of appropriate sensitivity of the method used, the particle size measurement was combined with visual control in accordance with the methodology and requirements of the European Pharmacopoeia [13].…”

Section: Discussionmentioning

confidence: 99%

Safe Practice of Y-Site Drug Administration: The Case of Colistin and Parenteral Nutrition

et al. 2020

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A serious problem in everyday clinical practice is the co-administration of drugs using the same infusion line. Potential complications of co-administration of incompatible drugs include precipitation in the infusion line or central venous catheter leading to its occlusion. Administration of precipitate and large lipid droplets into the venous system may lead to the embolization of capillaries and local or systemic inflammatory reactions, with the consequences of venous thrombosis, chronic venous insufficiency, and even pulmonary embolism. The co-administration of drugs must always be confirmed and clearly defined. The study aimed to determine the interaction between colistin (COL) in the dose used during intermittent hemodialysis and five different ready-to-use PN admixtures (PN) (Kabiven, Smofkabiven, Olimel N9E, Nutriflex Lipid Special, and Nutriflex Omega Special). COL-PN compatibilities were tested by comparing physicochemical properties (pH, zeta potential, lipid emulsion particle size) of COL and PN at three time points: immediately after sample preparation, after ten minutes, and after four hours. No changes in the visual inspection were observed. Both PN without COL and COL-PN samples remained white, homogeneous oil-in-water emulsions with no signs of phase separation, precipitation, or color change. There were no significant changes in pH, and the mean droplet diameter remained below the acceptance limit of 500 nm. The zeta potential and osmolality of COL-PN samples ranged from −21.4 to −7.22 mV and from 567 to 1304 mOsm/kg, respectively. The COL does not influence the physical stability of studied PN admixtures. The co-infusion of COL with Kabiven, Nutriflex Lipid Special, Olimel N9E, Nutriflex Omega Special, and Smofkabiven is possible in the dose used during intermittent hemodialysis.

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Physicochemical Stability and Sterility of Standard Parenteral Nutrition Solutions and Simulated Y‐Site Admixtures for Neonates

Abstract: The 2 tested standard ILE-free PN solutions for neonates are physicochemically stable and sterile for 31 days under refrigeration (4°C). These solutions are also stable in case of Y-site administration with ILE at the conditions tested.

Cited by 11 publications

References 18 publications

Effect of Lipid Emulsion on Stability of Ampicillin in Total Parenteral Nutrition

Effect of Lipid Emulsion on Stability of Ampicillin in Total Parenteral Nutrition

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

Safe Practice of Y-Site Drug Administration: The Case of Colistin and Parenteral Nutrition

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