Kinetic stability of all-in-one parenteral nutrition admixtures in the presence of high dose Ca2+ additive under clinical application circumstances

Abstract

BackgroundTPN infusions are usually administered during a treatment period of 10–24 hours per day due to the metabolic capacity of the liver. During this time interval physicochemically stable TPN solution (emulsion) is needed for the treatment. The purpose of the present study was to examine how the kinetic stability features of ready-made total parenteral nutrition admixtures containing olive oil and soybean oil will change under the usage-modeling 24-hour application with and without overdose Ca2+.MethodsParticle size analysis and zeta potential measurements were carried out to evaluate the possible changes in the kinetic stability of the emulsions.ResultsOur results indicate that in two of the four mixtures bimodal droplet-size distribution figures were detected and appearance of fat particles over 5 μm can not be disclosed. The tendency for separation of large diameter droplets in the two types of oil-based emulsion systems was different. In case of soybean containing emulsion second peak of droplets appeared in the bottom of the container in contrast to the olive oil containing emulsions where the second peak appeared in the surface layer. Interestingly this phenomenon is independent of calcium-content.ConclusionsFrom therapeutic point the emulsions of the bigger droplets containing upper layer are safer because the potentially dangerous big droplets could remain in the infusion bag after the administration.

Biological and Clinical Aspects of an Olive Oil-Based Lipid Emulsion—A Review

“…Several studies have reported that olive oil-based ILE better maintains its physicochemical stability compared with other currently available ILEs [ 111 , 113 ]. Compared with three soybean oil-based ILEs, olive oil-based ILE had the smallest globule size distribution, with the least variation in size between globules [ 2 ].…”

“…Furthermore, the use of MCBs eliminates the risk of precipitation or destabilization of the PN solution, which can occur when Y-site administration is used [ 115 ]. The stability of the ILE in MCBs was assessed and revealed that no fat particles over 5 microns were observed for either olive oil-based or soybean oil-based ILE [ 113 ]. Notably, the tendency for separation of large diameter droplets in the two emulsion systems was different, with the large droplets being located at the top of the bag in the olive oil-based ILE and at the bottom of the bag in the soybean oil-based ILE independent of the calcium content of the PN admixtures.…”

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

“…Otherwise, 12% of the particles exceeded the threshold of 1.0 µm and 2% were larger than 5.0 µm [13]. A similar study reported droplet sizes within the range 0.2-0.6 µmin different admixtures with and without calcium during the first 24 h of infusion [14]. Chemical and therapeutic safety was confirmed for 12 of the admixtures in the original study, although without transferability to other parenteral nutrition admixtures [12,13].…”

Assessment of the Physicochemical Stability of All‐in‐One Parenteral Emulsions for Neonates According to USP Specifications

“…The procedures followed in our study were identical to those proposed for clinical use. Since every parenteral formulation prepared in a hospital pharmacy has to be used within 24–30 hours 19 to decrease the risk of contamination, and because of the unpredictable kinetic stability of AIO parenteral admixtures (associated with their synthesis), 20 the characteristics of our admixtures were assessed on the day of preparation (within 3 hours) and then 24 hours after being connected to a supply pump, at room temperature. In addition to this, a second bag of each admixture was assessed after storage at 4°C for 24 hours because it is often desirable to prepare a formulation, store it, and use it later or the following day.…”