Abstract
BackgroundThe safe administration of parenteral admixtures should be considered under the headings of physical and chemical stability. Vitamins are considered to be most susceptible to chemical degradation.ObjectivesTo evaluate the protective effect of UV-protected monolayer ethylene vinyl acetate (EVA) bags in comparison with that of EVA bags without UV protection, on the physicochemical characteristics and stability of the light sensitive vitamins in pediatric parenteral admixtures stored under various temperature and light conditions.MethodsFour different parenteral pediatric admixtures (with trace elements and vitamins) in two types of ethylenovinylacetate (EVA) monolayer containers (with – yellow one and without – transparent one UV protection) were assessed. The physicochemical analyses such as visual inspection, pH and potential zeta measurements, lipid globules size distribution and vitamins concentration were performed at 0 h, 24 h, 8 days and 8 days+24 h after the preparation of the TPN admixtures. In order to quantify ascorbic acid, thiamine and pyridoxine levels, HPLC was used.ResultsNo differences (p < 0.05) in physicochemical stability of TPN admixtures were noted between two types of EVA bags, with the compositions assessed; stored 8 days (4 °C ± 2) without light plus 24 h at room temperature and light exposure. However significant differences were noticed in ascorbic acid, thiamine and pyridoxine content after 8 days+24 h in comparison with t = 0. This was noted for both for UV-protected bags and bags without UV-protection, Nevertheless, amounts were still within the pharmacopeial range.ConclusionsBoth EVA bags under test (with and without UV-protection) ensure physicochemical stability up 8 days at 4 °C ± 2 °C without light exposure and then 24 h at room temperature with light exposure for the total pediatric parenteral admixtures, intended for home parenteral nutrition.Graphical abstractScheme of physicochemical analysis of parenteral admixtures
Highlights
Parenteral nutrition is one of the most complex drug preparations used in modern medicine
All admixtures were prepared with trace elements and vitamins
Our findings provide new and valuable insights into the physicochemical stability of admixtures in monolayer bags which contain mixtures of vitamins and trace elements
Summary
Parenteral nutrition is one of the most complex drug preparations used in modern medicine. Detailed analysis of the nutritional mixtures indicate that almost 50 different components may be mixed together and stored in a single bag. Such complexity increases the chances of interactions, both between components, and between components and the packaging material [1, 2]. Problems of compatibility and stability can occur in total parenteral nutrition (TPN) admixtures prepared. DARU J Pharm Sci (2019) 27:255–264 for, and administered to premature infants This is largely due to the resulting higher concentrations of nutrients per unit volume in the reduced final volume necessary for neonatal admixtures [3, 4].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
