Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions
Abstract
The aim of this study was to develop, characterize and evaluate concentrated nanoemulsions (20%) for parenteral nutrition. Those systems were developed by the high-pressure homogenization method. Optimal conditions for the nanoemulsion production were identified using 2(4-1) fractional factorial design. The characterization of physicochemical parameters was carried out immediately after the nanoemulsion production, and after 10 and 30 days. The biological control was conducted 30 days after their preparation as well. The oil phase contained the combination of the soybean (SO) and fish oil (FO) as well as the fish oil and medium-chain triglycerides (MCT), while the aqueous phase was composed of water for injections. The egg yolk phospholipids (EP) were used as surfactants alone, or in combination with Poloxamer 188 (PI). The obtained results were in accordance with the literature date e.i. quality requirements for parenteral emulsions (the droplet diameter lt = 500 nm, PDI lt = 0.25, ...absolute value of zeta-potential gt = 25 mV, pH-value in the range of 6-9). It was shown that the combination of two surfactants (the egg yolk phospholipids that provides the electrostatic stabilization and Poloxamer 188-steric stabilizer) used as emulsifiers ensures the optimal quality of the obtained nanoemulsions for parenteral nutrition.
Keywords:
Nanoemulsions / Parenteral nutrition / Stability / Polydispersity index / Fractional factorial designSource:
Journal of Drug Delivery Science and Technology, 2017, 39, 341-347Publisher:
- Elsevier, Amsterdam
DOI: 10.1016/j.jddst.2017.04.004
ISSN: 1773-2247
WoS: 000404312200037
Scopus: 2-s2.0-85018486670
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Institution/Community
Tehnološko-metalurški fakultetTY - JOUR AU - Mirković, Dušica AU - Ibrić, Svetlana AU - Balanč, Bojana AU - Knez, Željko AU - Bugarski, Branko PY - 2017 UR - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3729 AB - The aim of this study was to develop, characterize and evaluate concentrated nanoemulsions (20%) for parenteral nutrition. Those systems were developed by the high-pressure homogenization method. Optimal conditions for the nanoemulsion production were identified using 2(4-1) fractional factorial design. The characterization of physicochemical parameters was carried out immediately after the nanoemulsion production, and after 10 and 30 days. The biological control was conducted 30 days after their preparation as well. The oil phase contained the combination of the soybean (SO) and fish oil (FO) as well as the fish oil and medium-chain triglycerides (MCT), while the aqueous phase was composed of water for injections. The egg yolk phospholipids (EP) were used as surfactants alone, or in combination with Poloxamer 188 (PI). The obtained results were in accordance with the literature date e.i. quality requirements for parenteral emulsions (the droplet diameter lt = 500 nm, PDI lt = 0.25, absolute value of zeta-potential gt = 25 mV, pH-value in the range of 6-9). It was shown that the combination of two surfactants (the egg yolk phospholipids that provides the electrostatic stabilization and Poloxamer 188-steric stabilizer) used as emulsifiers ensures the optimal quality of the obtained nanoemulsions for parenteral nutrition. PB - Elsevier, Amsterdam T2 - Journal of Drug Delivery Science and Technology T1 - Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions EP - 347 SP - 341 VL - 39 DO - 10.1016/j.jddst.2017.04.004 ER -
@article{ author = "Mirković, Dušica and Ibrić, Svetlana and Balanč, Bojana and Knez, Željko and Bugarski, Branko", year = "2017", abstract = "The aim of this study was to develop, characterize and evaluate concentrated nanoemulsions (20%) for parenteral nutrition. Those systems were developed by the high-pressure homogenization method. Optimal conditions for the nanoemulsion production were identified using 2(4-1) fractional factorial design. The characterization of physicochemical parameters was carried out immediately after the nanoemulsion production, and after 10 and 30 days. The biological control was conducted 30 days after their preparation as well. The oil phase contained the combination of the soybean (SO) and fish oil (FO) as well as the fish oil and medium-chain triglycerides (MCT), while the aqueous phase was composed of water for injections. The egg yolk phospholipids (EP) were used as surfactants alone, or in combination with Poloxamer 188 (PI). The obtained results were in accordance with the literature date e.i. quality requirements for parenteral emulsions (the droplet diameter lt = 500 nm, PDI lt = 0.25, absolute value of zeta-potential gt = 25 mV, pH-value in the range of 6-9). It was shown that the combination of two surfactants (the egg yolk phospholipids that provides the electrostatic stabilization and Poloxamer 188-steric stabilizer) used as emulsifiers ensures the optimal quality of the obtained nanoemulsions for parenteral nutrition.", publisher = "Elsevier, Amsterdam", journal = "Journal of Drug Delivery Science and Technology", title = "Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions", pages = "347-341", volume = "39", doi = "10.1016/j.jddst.2017.04.004" }
Mirković, D., Ibrić, S., Balanč, B., Knez, Ž.,& Bugarski, B.. (2017). Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions. in Journal of Drug Delivery Science and Technology Elsevier, Amsterdam., 39, 341-347. https://doi.org/10.1016/j.jddst.2017.04.004
Mirković D, Ibrić S, Balanč B, Knez Ž, Bugarski B. Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions. in Journal of Drug Delivery Science and Technology. 2017;39:341-347. doi:10.1016/j.jddst.2017.04.004 .
Mirković, Dušica, Ibrić, Svetlana, Balanč, Bojana, Knez, Željko, Bugarski, Branko, "Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions" in Journal of Drug Delivery Science and Technology, 39 (2017):341-347, https://doi.org/10.1016/j.jddst.2017.04.004 . .