Physicochemical stability of lipid injectable emulsions: Correlating changes in large globule distributions with phase separation behavior

Gonyon, Thomas; Patel, Pankaj S.; Owen, Heather; Dunham, Andrew; Carter, Phillip W.

doi:10.1016/j.ijpharm.2007.05.038

Cited by 21 publications

(18 citation statements)

References 28 publications

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“…20 Two main DSD characterization techniques have been widely used with parenteral emulsions: (1) single-particle optical sensing (SPOS) and (2) laser diffraction. SPOS may elucidate details of the DSD tail (on a distribution curve) of the larger droplets [21][22][23] and is based on light obscuration by individual large droplets.…”

Section: Resultsmentioning

confidence: 99%

“…However, Gonyon et al 20 questioned the validity of USP's PFAT 5 limit based on single-point determination of the PFAT 5 of the native emulsion. They concluded that the USP's PFAT 5 limit, currently based on stability considerations, is not defined using the measured rate of change in large fat globules.…”

Section: Resultsmentioning

confidence: 99%

“…Intralipid lipid injectable emulsions comply with the large-globule size limit established by USP chapter 729 for lipid injectable emulsions. However, it is worth noting that this upper limit has been questioned by Gonyon et al,20 who maintained that the PFAT 5 limit is based on stability concerns and is not defined on the …”

Section: Resultsmentioning

confidence: 99%

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Droplet-size distribution and stability of lipid injectable emulsions

Gallegos

Partal

Franco

2009

American Journal of Health-System Pharmacy

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Droplet-size distribution and stability of lipid injectable emulsions

Gallegos

Partal

Franco

2009

American Journal of Health-System Pharmacy

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“…We followed the methodology previously described [17,26,27]. Analysis were performed using the previously calibrated PAMAS Particle Counter equipment (model SVSS, PAMAS GmbH, Sttutgart, Germany), utilizing a sensor HCB-LD-50/50, in extinction mode and software according to CFR 21 part 11.…”

Section: Methodsmentioning

confidence: 99%

“…The diameters selected for the analysis were 2.0, 5.0, 7.5, 10, 15, 20, 25 and 30 μm; the flow rate was 10 mL/min and the volume accuracy was ± 0.4 %. The calculation of PFATx was based on previous descriptions [27,28]. Particle sizes were grouped with their respective counts.…”

Section: Methodsmentioning

confidence: 99%

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

Lobo

Veiga

Cabral

et al. 2012

Nutr J

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ObjectiveThe present study aimed to evaluate the influence of the relative composition of trace elements and vitamins in physicochemical stability of neonatal parenteral nutrition.Material and methodsThree formulations for neonatal administration were selected; the main variable was the presence of trace elements and vitamins. The analyses where carried out immediately after preparation and at 24 h, 48 h, 72 h and 7 days after preparation. Three methods were selected to determine globule size: light obscuration, dynamic light scattering and optical microscopy. Complementary evaluation including visual inspection, determination of pH and osmolarity, peroxide levels and measurements of zeta potential were also performed.ResultsThere was an observable alteration in color and phase separation in the PN stored at 25°C and 40°C. Neither globule size pattern, nor any other physicochemical characteristic evaluated appeared to be considerably altered in any of the analyzed formulations even after 7 days of storage at 5°C. Globule size in all the PN studied was consistent with the established limit, below 500 nm by DLS measurement, and PFAT5 was below 0.05% under all storage temperatures.ConclusionConcomitant presence of trace elements and vitamins in the same neonatal formulation did not alter the evaluated aspects of stability.

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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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Physicochemical stability of lipid injectable emulsions: Correlating changes in large globule distributions with phase separation behavior

Cited by 21 publications

References 28 publications

Droplet-size distribution and stability of lipid injectable emulsions

Droplet-size distribution and stability of lipid injectable emulsions

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

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

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