Influence of the relative composition of trace elements and vitamins in physicochemical stability of total parenteral nutrition formulations for neonatal use

Lobo, Bianca Waruar; Veiga, Venício Féo da; Cabral, Lúcio Mendes; Michel, Ricardo C.; Volpato, Nádia Maria; Sousa, Valéria Pereira de

doi:10.1186/1475-2891-11-26

Cited by 15 publications

(18 citation statements)

References 44 publications

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“…Dynamic light scattering has been used in previous studies to measure particle size in PN formulations . Particles with a diameter size larger than 5 µm, if infused into a patient, increase the risk of developing fat emboli with clinical implications .…”

Section: Discussionmentioning

confidence: 99%

“…Dynamic light scattering has been used in previous studies to measure particle size in PN formulations. [18][19][20] Particles with a diameter size larger than 5 μm, if infused into a patient, increase the risk of developing fat emboli with clinical implications. 11,12 In this study, for all samples (including controls) measured at all times points, the average diameter of particles was less than 5 μm.…”

Section: Discussionmentioning

confidence: 99%

“…Our methodology and results also reflect the guidance set by the United States Pharmacopeia (USP) for assessing the stability of all-in-one PN admixtures for neonates. 19,20 To be deemed stable under USP criteria, average droplet diameter for lipid injectable emulsions must be less than 500 nm, with no particles having diameter larger than 5 μm.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the physicochemical compatibility of cyclosporin infusion and parenteral nutrition when intravenously administered via the same central line lumen

Coutsouvelis

Dong

Witney

et al. 2015

Pharmacy Practice and Res

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Background: Patients undergoing allogeneic haematopoietic stem cell transplantation require cyclosporin (CsA) infusion to be administered concurrently with parenteral nutrition (PN). Aims: To evaluate the physicochemical compatibility of parenteral CsA and PN administered via the same lumen of a central venous access device and to quantify and identify any particulate matter. Methods: Three PN formulations were tested. Standard PN solution and PN solution with glutamine manufactured by Baxter Healthcare and standard PN solution manufactured by Fresenius Kabi. CsA concentrate for intravenous infusion 250 mg/5 mL (Sandimmun, Novartis Pharmaceuticals) was used. PN solutions were mixed with CsA at different volume ratios to simulate different rates of co-infusion in clinical practice. A real-life simulation was also performed with CsA in glucose 5% co-infused with the PN solution via the same lumen of a central venous access device. The size of colloidal species in the resulting samples was measured using dynamic light scattering. Results:The static experiments for all dilution ratios and types of PN with CsA indicated average particle diameters of less than 500 nm. Only one sample indicated a particle larger than 5 μm. The 'real-life' simulation did not detect any particle with diameter greater than 5 μm. This was across all types of PN solutions and for all samples taken at a number of time points up to 24 h. Conclusion: Commercially available PN formulations can be administered concurrently with CsA via the same lumen of a central venous access device. For infusions running up to 24 h, there is minimal risk of particle formation with a diameter greater than 5 μm.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Evaluation of the physicochemical compatibility of cyclosporin infusion and parenteral nutrition when intravenously administered via the same central line lumen

Coutsouvelis

Dong

Witney

et al. 2015

Pharmacy Practice and Res

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“…The products of ascorbic acid degradation, oxalic acid and threonic acid, may compromise the stability of the emulsion by increasing the acidity. pHs below 5 can destabilize the PN emulsions 38 . In addition, oxalic acid interacts with free calcium to produce calcium oxalate precipitate 6 .…”

Section: Ascorbic Acidmentioning

confidence: 99%

A review of stability issues associated with vitamins in parenteral nutrition

et al. 2014

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Background & aims: There has been a move to increased emphasis on delivering parenteral nutrition to patients at home, which may improve patient care and reduce costs. However, safe provision of home, and indeed any, parenteral nutrition necessitates consideration of the physical and chemical stability of the parenteral nutrition and its components.Methods: Medline and Embase were used to search for all English-language publications on vitamin stability. Identified publications were then analysed and summarised in the following review.Results: Vitamins are one of the least stable components in PN and there are three main ways in which they have been shown to degrade: photodegradation, oxidation and through storage material interaction.Previous research on vitamins has demonstrated that significant losses can occur in the bag, which could have clinical consequences, particularly for long-term users of parenteral nutrition. These losses are most dramatic for vitamin C, which is rapidly degraded by oxygen, and vitamin A, which is rapidly degraded in the presence of sunlight.Conclusions: There are a number of stability issues associated with vitamins in parenteral nutrition and further investigation is needed to assure their stability and compatibility with other parenteral nutrition constituents.

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“…Problems of compatibility and stability can occur particularly in total parenteral nutrition (TPN) admixtures prepared for, and administered to premature infants. This is largely due to the resulting higher concentrations of nutrients per unit volume in the reduced final volume necessary for neonatal admixtures [3, 4]. Proper planning of parenteral nutrition in children is a significant challenge, and much more complex than parenteral nutrition in adult patients [5, 6].…”

Section: Introductionmentioning

confidence: 99%

The effect of UV-protected ethylene vinyl acetate (EVA) bags on the physicochemical stability of pediatric parenteral nutrition admixtures

Wątróbska-Świetlikowska

MacLoughlin

2019

DARU J Pharm Sci

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Background The safe administration of parenteral admixtures should be considered under the headings of physical and chemical stability. Vitamins are considered to be most susceptible to chemical degradation. Objectives To evaluate the protective effect of UV-protected monolayer ethylene vinyl acetate (EVA) bags in comparison with that of EVA bags without UV protection, on the physicochemical characteristics and stability of the light sensitive vitamins in pediatric parenteral admixtures stored under various temperature and light conditions. Methods Four different parenteral pediatric admixtures (with trace elements and vitamins) in two types of ethylenovinylacetate (EVA) monolayer containers (with – yellow one and without – transparent one UV protection) were assessed. The physicochemical analyses such as visual inspection, pH and potential zeta measurements, lipid globules size distribution and vitamins concentration were performed at 0 h, 24 h, 8 days and 8 days+24 h after the preparation of the TPN admixtures. In order to quantify ascorbic acid, thiamine and pyridoxine levels, HPLC was used. Results No differences ( p < 0.05) in physicochemical stability of TPN admixtures were noted between two types of EVA bags, with the compositions assessed; stored 8 days (4 °C ± 2) without light plus 24 h at room temperature and light exposure. However significant differences were noticed in ascorbic acid, thiamine and pyridoxine content after 8 days+24 h in comparison with t = 0. This was noted for both for UV-protected bags and bags without UV-protection, Nevertheless, amounts were still within the pharmacopeial range. Conclusions Both EVA bags under test (with and without UV-protection) ensure physicochemical stability up 8 days at 4 °C ± 2 °C without light exposure and then 24 h at room temperature with light exposure for the total pediatric parenteral admixtures, intended for home parenteral nutrition. Graphical abstract Scheme of physicochemical analysis of parenteral admixtures

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Influence of the relative composition of trace elements and vitamins in physicochemical stability of total parenteral nutrition formulations for neonatal use

Cited by 15 publications

References 44 publications

Evaluation of the physicochemical compatibility of cyclosporin infusion and parenteral nutrition when intravenously administered via the same central line lumen

Evaluation of the physicochemical compatibility of cyclosporin infusion and parenteral nutrition when intravenously administered via the same central line lumen

A review of stability issues associated with vitamins in parenteral nutrition

The effect of UV-protected ethylene vinyl acetate (EVA) bags on the physicochemical stability of pediatric parenteral nutrition admixtures

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