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 24-1 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 (Pl). The obtained results were in accordance with the literature date e.i. quality requirements for parenteral emulsions (the droplet diameter ≤ 500 nm, PDI ≤ 0.25, absolute value of ζ–potential ≥ 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.