All-in-One Pediatric Parenteral Nutrition Admixtures with an Extended Shelf Life—Insight in Correlations between Composition and Physicochemical Parameters

Abstract

The administration of three-in-one parenteral nutrition (PN) admixtures to pediatric patients requires special consideration, specifically concerning quality and physicochemical stability. The introduction of a new parenteral amino acid solution into the market prompted us to evaluate Aminoplasmal Paed-based PN admixtures’ stability. The study aimed to determine the physicochemical parameters of the chosen variations of PN admixtures and search for a correlation between its composition and those parameters. One hundred and sixty-eight variations of PN admixtures intended for patients weighing from 10 to 25 kg and aged from 1 to 12 years and differing in the quantitative composition of electrolytes were selected for the study. The samples were prepared using each of the four intravenous lipid emulsions dedicated to pediatric patients: Intralipid 20%, Clinoleic 20%, Lipidem 20%, and Smoflipid 20%. The stability of the PN admixtures was assessed by visual inspection and determination of pH, osmolality, zeta potential, and hydrodynamic mean droplet diameter (MDD) immediately upon preparation and after seven days of storage at the temperature of 5 ± 1 °C with light protection. Pearson’s correlation was used to quantify the relationships between selected ingredients of the PN admixtures and the physicochemical parameters. The PN admixtures were characterized by pH ranging from 5.91 to 7.04, osmolality ranging from 1238 to 1678 mOsm/kg, and zeta potential ranging from −41.3 to −2.16 mV. The changes in pH and osmolality after seven days of storage did not exceed 0.2 and 4.4%, respectively. The homogeneity of the PN admixtures was confirmed by determining the polydispersity index, which ranged from 0.06 to 0.2. The MDD of the studied formulas ranged from 235 to 395 nm and from 233 to 365 nm immediately upon preparation and after the storage period, respectively. Correlations between selected components of the PN admixtures and some physicochemical parameters were found. All Aminoplasmal Paed 10%-based PN admixtures were characterized by appropriate physicochemical quality to be administered via the central veins, both immediately upon preparation and after seven days of storage at the temperature of 5 ± 1 °C with light protection. The applied electrolyte concentrations ranges and types of lipid emulsions in the selected macronutrient quantitative compositions allowed the PN admixtures to remain stable for seven days within the specified limits.

Honokiol-Loaded Nanoemulsion for Glioblastoma Treatment: Statistical Optimization, Physicochemical Characterization, and an In Vitro Toxicity Assay

“…The slight, insignificant changes of the studied parameters, i.e., MDD, ZP, and PDI, result from the dynamics of the oil-in-water system and the specificity of the measurement techniques used. In accordance with the criteria set up for parenteral nutrition that from a physiochemical point of view is a dilution of intravenous nanoemulsion, e.g., Lipofindin MCT/LCT 20% with various nutrients in the form of water solutions, the following limits have been identified as relevant to consider the honokiol-loaded nanoemulsion stable and presenting satisfactory quality: MDD < 500 nm [ 33 ] and PDI ≤0.7, and ZP cannot take a positive value [ 53 , 54 ]. In all the studied conditions, honokiol-loaded nanoemulsion met the established criteria proving its good stability.…”

The Development of Magnolol-Loaded Intravenous Emulsion with Low Hepatotoxic Potential

“…Before introducing such formulation into clinical practice, it is also crucial to perform long-term stability studies (shelf-life tests) and check the compatibility with other ingredients of parenteral nutrition admixtures. Since such data allow for successful implementation and immediate practical application of the developed formulation [ 13 , 44 ]. Nevertheless, as shown in many other studies on intravenous lipid emulsion, the sterilization, and long-term stability studies are not always presented at such an early stage of the formulation development [ 45 ].…”