Nanoemulsions for Parenteral Nutrition as Industrial or Laboratory Preparations

  • Dušica Mirković Military Medical Academy, Sector of Pharmacy, Department of Pharmaceutical Technology, Belgrade, Serbia
  • Svetlana Ibrić University of Belgrade, Faculty of Pharmacy, Department of Pharmaceutical Technology and Cosmetology

Sažetak


Background/Aim. The application of nanoemulsions (NE) for the parenteral nutrition represents a very important advancement that marked the Medicine and Pharmacy of the twentieth century. Over the years, the technology of the production of nanoemulsions or admixtures for the Total Parenteral Nutrition (TPN) has undergone a constant improvement.

This paper representing the continuation of the previous research deals with nanoemulsions with a concentration of 20%, and which were prepared under laboratory conditions. The main emphasis was put on the possibility of detecting the potential presence of large droplets or agglomerates of droplets that could cause fatal effects. In addition, the quality assessment for the TPN admixture containing these nanoemulsions was performed. The results were compared with the results obtained by monitoring the TPN admixture prepared from the industrial emulsion (Lipofundin MCT/LCT 20%®).

Methods. During the 30-day period of monitoring nanoemulsion physical-chemical characteristics, the volume diameters that define the width of the lipid droplet size distribution were determined using the laser diffraction method. The characterization of nanoemulsions also included the measurement of electrical conductivity and the peroxide number. In addition, the TPN physical and chemical characteristics were monitored for 72 hours and included: the measurement of the mean droplet diameter, the volume diameter, the distribution of the droplet size (PDI), the ζ-potential, and the pH values.

Results. The obtained results were in accordance with the literature data related to the quality of parenteral nanoemulsions (the values ​​of volume diameters ranged between 50 and 490 nm, the electrical conductivity ranged from 415 to 266 µS/cm, and the peroxide value from 0.06 up to 0.12). The TPN admixtures remained stable during the testing period, even in the cases when the TPN admixtures containing either a newly formed or an industrial nanoemulsion were tested.

Conclusion. All these results point to the fact that under the conditions of storage time, and at the ambient temperature, the investigated nanoemulsion characteristics do not significantly alter. If the principles of preparation and the order of mixing components are followed, the TPN admixture possessing satisfactory physical and chemical quality and stability can be obtained.

Reference

Mirković D, Ibrić S, Antunović M. Quality assessment of total parenteral nutrition admixtures by the use of fractional facto-rial design. Vojnosanit Pregl 2013; 70 (4): 374–9.

Austin P, Stroud M. Prescribing Adult Intravenous Nutrition. 1st ed. London: Pharmaceutical Press; 2007.

Wabel C. Influence of lecithin on structure and Stability of Parenteral Fat Emulsions [dissertation]. Nürnberg: Universität Erlangen; 1998.

Lawrence J. Disperse systems. In: Denton P, Rostron C, editors. Pharmaceutics: The Science of Medicine Design. Oxford: Ox-ford University Press; 2013. p. 180–1.

Tadros T, Izquierdo P, Esquena J, Solans C. Formation and sta-bility of nanoemulsions. Adv Colloid Interface Sci 2004; 108–109: 303–18.

Kozić Đ. Thermodynamics – principles and applications. 2nd ed. Belgrade: Faculty of Mechanical Engineering, University of Belgrade; 2012. (Serbian)

Mason TG, Wilking JN, Meleson K, Chang CB, Graves SM. Nanoemulsions: formation, structure, and physical properties. J Phys Condens Matter 2006; 18: R635–66.

Jumaa M, Müller BW. The effect of oil components and ho-mogenization conditions on the physicochemical properties and stability of parenteral fat emulsions. Int J Pharm1998; 163(1–2): 81–9.

Benita S, Levy MY. Submicron emulsions as colloidal drug car-riers for intravenous administration: Comprehensive physico-chemical characterization. J Pharm Sci 1993; 82(11): 1069–79.

United States Pharmacopeia 39 and National Formulary 34 (USP39–NF34). Globule size distribution in lipid injectable emulsions. Rockville, MD: The United States Pharmacopoeial Convention; 2016.

Ball PA. Methods of assessing stability of parenteral nutrition regimens. Curr Opin Clin Nutr Metab Care 2001; 4(5): 345–9.

Washington C, Athersuch A, Kynoch D. The electrokinetic prop-erties of phospholipid stabilized fat emulsions. The effect of glucose and pH. Int J Pharm 1990; 64: 217–22.

Mirković D, Ibrić S, Balanč B, Knez Ž, Bugarski B. Evaluation of the impact of critical quality attributes and critical process pa-rameters on quality and stability of parenteral nutrition nanoemulsions. J Drug Deliv Sci Technol 2017; 39: 341–7.

Rungseevijitprapa W, Siepmann F, Siepmann J, Paeratakul O. Dis-perse Systems. In: Florence IA, Siepmann J, editors. Modern Pharmaceutics. New York: Taylor & Francis Group; 2010. p. 398.

Hamishehkar H, Emami J, Najafabadi AR, Gilani K, Minaiyan M, Mahdavi H et al. The effect of formulation variables on the characteristics of insulin-loaded poly(lactic-co-glycolic acid) microspheres prepared by a single phase oil in oil solvent evaporation method. Colloids Surf B Biointerfaces 2009; 74(1): 340–9.

Sobotka L, Allison S, Fürst P, Meier R, Pertkiewicz M, Soeters P. Basics in clinical nutrition. 3rd ed. Prague: House Galén; 2004.

McKinnon BT. FDA safety alert: hazards of precipitation asso-ciated with parenteral nutrition. Nutr Clin Pract 1996; 11(2): 59–65.

Mirtallo J, Canada T, Johnson D, Kumpf V, Petersen C, Sacks G, et al. Task force for the Revision of Safe Practices for Paren-teral Nutrition. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr 2004; 28(6): S39-70.

Taylor P. Ostwald ripening in emulsions. Colloids Surf A Phys-iochem Eng Asp 1995; 99(Suppl 2–3): 175–85.

McClements DJ. Edible nanoemulsions: fabrication, properties, and functional performance. Soft Matter 2011; 7(6): 2297–316.

Driscoll DF. Commercial lipid emulsions and all-in-one mix-tures for intravenous infusion – composition and physico-chemical properties. World Rev Nutr Diet 2015; 112: 48–56.

Tadros TF. Emulsion stability. In: Becher P, editor. Encyclope-dia of Emulsion Technology. New York: Marcel Dekker; 1983. p. 129–285.

Trotta M, Pattarino F, Ignoni T. Stability of drug-carrier emul-sions containing phosphatidylcholine mixtures. Eur J Pharm Biopharm 2002; 53(2): 203–8.

Han F, Li S, Yin R, Liu H, Xu L. Effect of surfactants on the formation and characterization of a new type of colloidal drug delivery system: Nanostructured lipid carriers, Colloids Surf A Physiochem Eng Asp 2008; 315(1–3): 210–6.

Müller RH, Schmidt S, Buttle I, Akkar A, Schmitt J, Brömer S. SolEmuls® – novel technology for the formulation of i.v. emulsions with poorly soluble drugs. Int J Pharm 2004; 269: 293–302.

Klang V, Matsko N, Raupach K, El-Hagin N, Valenta C. Devel-opment of sucrose stearate-based nanoemulsions and optimi-zation through γ-cyclodextrin. Eur J Pharm Biopharm 2011; 79(1): 58–67.

Benita S, Levy MY. Submicron emulsions as colloidal drug car-riers for intravenous administration: comprehensive physico-chemical characterization. J Pharm Sci 1993; 82(11): 1069–79.

Rozentur E, Nassar T, Benita S. Materials for nanoemulsions and their influence on the biofate. In: Torchilin V, Amiji MM, editors. Handbook of materials for nanomedicine. Singapore: Pan Stanford Publishing Pte. Ltd.; 2010. p. 515–54.

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2021/04/12
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