Investigation of short-term stability of parenteral nutrition nanoemulsions prepared under laboratory conditions

Abstract

Background/Aim. The application of nanoemulsions (NE) in 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 NE and total parenteral nutrition (TPN) nanoemulsions or admixtures has undergone constant improvement. Representing the continuation of the previous research, this paper deals with nanoemulsions in a concentration of 20% that 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 of the TPN admixture containing these nanoemulsions was performed. These results were compared with the results obtained from 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. In addition, TPN physical and chemical characteristics were monitored for 72 hours and included: measurements of the mean droplet diameter, the volume diameter, distribution of the droplet size, ie. polydispersity index (PDI), ?-potential, and pH values. Results. Obtained results were in accordance with the literature data related to the quality of parenteral nanoemulsions (values of volume diameters ranged between 50 and 490 nm). TPN admixtures remained stable during the testing period, even in cases when TPN admixtures containing either a newly formed or an industrial nanoemulsion were tested. Conclusion. Characteristics of investigated nanoemulsions do not significantly alter under the ambient temperature storage. If the preparation principles and the component mixing order are followed, TPN admixture possessing satisfactory physical and chemical quality and stability can be obtained.