Droplet-size distribution and stability of lipid injectable emulsions

Gallegos, C.; Partal, P.; Franco, J.M.

doi:10.2146/ajhp080031

Cited by 16 publications

(11 citation statements)

References 29 publications

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“…All data are presented as the mean ± standard deviation (SD). The PFAT 5 values are in agreement with the previously reported data by Gallegos et al (2009).…”

Section: Introductionsupporting

confidence: 92%

“…It was demonstrated that Intralipid since October 2006 complies with the limit (Driscoll, 2009), well in advance of the introduction of the droplet size monograph in the USP in December 2007. The adherence of Intralipid in plastic packaging to the USP limit has previously also been addressed and verified by other authors (Gallegos et al, 2009). …”

Section: Introductionsupporting

confidence: 56%

“…However, in his recent investigation Gallegos et al (2009) claimed that also Kabiven shows PFAT 5 < 0.05%.…”

Section: Introductionmentioning

confidence: 96%

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Comment to “The pharmacopeial evolution of Intralipid injectable emulsion in plastic containers: From a coarse to a fine emulsion”

Ellborg¹,

Ferreira²,

Mohammadnejad³

et al. 2010

International Journal of Pharmaceutics

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“…All data are presented as the mean ± standard deviation (SD). The PFAT 5 values are in agreement with the previously reported data by Gallegos et al (2009).…”

Section: Introductionsupporting

confidence: 92%

Section: Introductionsupporting

confidence: 56%

See 1 more Smart Citation

Comment to “The pharmacopeial evolution of Intralipid injectable emulsion in plastic containers: From a coarse to a fine emulsion”

Ellborg¹,

Ferreira²,

Mohammadnejad³

et al. 2010

International Journal of Pharmaceutics

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“…Commercially prepared IVFE has a mean particle size (MPS) of about 0.33–0.4 µm in diameter 25 . At this size range, the IVFE particle mimics naturally occurring chylomicrons.…”

Section: Particle Sizementioning

confidence: 99%

PFAT5 and the Evolution of Lipid Admixture Stability

Klang

2015

J Parenter Enteral Nutr

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PFAT5 is defined by United States Pharmacopeia Chapter 729 as follows: the "percentage of fat residing in globules larger than 5 µm (PFAT5) for a given lipid injectable emulsion [is] not to exceed 0.05%." The unstable aggregates are trapped in lungs, liver, and the reticuloendothelial system. Large particles will accumulate in pulmonary capillaries, which are between 4 and 9 µm in diameter. Over the years, there has been an evolution of methods to characterize and define intravenous fat emulsion (IVFE) stability when combined as a total nutrient admixture (TNA). Many studies have claimed IVFE stability measuring mean particle size, zeta potential, and visual checks. Interestingly, none of the studies that claimed the TNA as stable identified an unstable one through testing. This report reviews those parameters and shows they were not a valid measure of lipid stability. The PFAT5 parameter has emerged as the only validated measure of lipid stability. There are clinical consequences of using lipids that exceed the PFAT5 limit. This parameter is applicable to both manufactured and compounded lipid preparations. The clinician should be aware of the limitations of much of the literature concerning the lipid stability assessment. More stability studies are needed using PFAT5 to identify the actual limits of TNA compounding.

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“…Droplet size distribution is of great importance because of its fundamental information about many characteristics such as the rheology [27], the stability of emulsion and performance of stabilizers [28]. According to the stocks law, the velocity of phase separation in an emulsion is proportional to the square of its dispersed phase radius.…”

Section: Particle Size Distributionmentioning

confidence: 99%

Physical stability of oil-in-water emulsions in the presence of gamma irradiated gum tragacanth

Mollakhalili‐Meybodi

Mohammadifar

Farhoodi

et al. 2016

Journal of Dispersion Science and Technology

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Gum tragacanth (GT) exuded from an Iranian Astragalus species was γ-irradiated at 0, 0.75, 1.5, 3, 5, 7, 10 kGy and used to stabilize a model oil in water emulsion system. Stability and physicochemical properties of emulsion samples were investigated with respect to the effect of irradiation treatment on functional properties of gum tragacanth.Particle size distribution, interfacial tension, zeta potential, steady shear and oscillatory rheological measurements were used to characterize and evaluate the emulsion samples and obtain more information about the possible stability mechanism. Emulsions were prepared by homogenizing 10% w/w sun flower oil with 90% w/w aqueous gum dispersions and stored quiescently at 25ºC for 120 days. Results indicated that using 1.5 kGy irradiated GT was more effective in providing optimum values of apparent viscosity, number mean diameter, electrosteric repulsion and structure strength for getting maximum emulsion stability. GT significantly reduced the interfacial tension of the oil and water system, but no significant differences were observed among all irradiation treated and non-irradiated samples. This study revealed that, GT acts as a bifunctional 2 emulsifier and irradiation treatment has a great positive influence on its ability to reduce droplets collision frequency and stabilize oil in water emulsion. GRAPHICAL ABSTRACT

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Droplet-size distribution and stability of lipid injectable emulsions

Abstract: Multiple lots of a lipid emulsion were found to have acceptable PFAT(5) and mean droplet-size values, regardless of oil content, container size, or storage time and tempearture.

Cited by 16 publications

References 29 publications

Comment to “The pharmacopeial evolution of Intralipid injectable emulsion in plastic containers: From a coarse to a fine emulsion”

Comment to “The pharmacopeial evolution of Intralipid injectable emulsion in plastic containers: From a coarse to a fine emulsion”

PFAT5 and the Evolution of Lipid Admixture Stability

Physical stability of oil-in-water emulsions in the presence of gamma irradiated gum tragacanth

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