Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use

Abstract

BackgroundThe objective of this work was to study the vitamins B1, B2, B6 and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods.MethodsThe study was carried out during 72 h with formulations packaged in recommended storage temperature (4°C) and 25°C, with and without photoprotection.ResultsThe results showed that the methodologies used for assessing the chemical stability of vitamins B1, B2, B6 and C in the formulation were selective, linear, precise and accurate. The vitamins could be considered stable in the formulation during the three days of study if stored at 4°C. When stored at 25°C vitamin C presented instability after 48 h.ConclusionThe pediatric formulation containing high amount of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulphate, pediatric vitamins and trace elements packaged in bag-type trilaminate presented a shelf life of the 72 h, when maintained under refrigeration, between 2°C and 8°C. This shelf life was measured considering the vitamins studied. Further studies are needed including all the vitamins present in this formulation.

Vitamin C supplementation in the critically ill patient

“…1). The residual ascorbic acid after a few hours is close to zero even with light protection [62]. The logical administration of a combination of micronutrients theoretically obscures the proper role of each of them and in this case of vitamin C. But the synergistic interaction of a-tocopherol and vitamin C has proven effective for enhancing the antioxidant capacity of a-tocopherol [7].…”

Physicochemical Stability and Sterility of Standard Parenteral Nutrition Solutions and Simulated Y‐Site Admixtures for Neonates

“…The evaluated samples were taken from cooled solutions, not considering that PN are perfused at room temperature. Second, vitamin degradation was not assessed as preparations were compounded in EVA multilayered bags and stored at 4°C inside photoprotective covers, which minimize oxidation . Although vitamin concentration may progressively decrease in PN solutions under the conditions similar to that of our study, neonates are not usually fed by parenteral route exclusively.…”

Parenteral nutrition in a neonatal intensive care unit: galenic stability of four all-in-one admixtures

“…We decided to set the lower limit of lipid percentage at 4% since it is the lowest percentage studied and stable in conditions of the study and of use in our neonatal intensive care unit. Regarding the use-by date, although we performed a 7-day galenic stability assessment, some important chemical analyses are missing, such as vitamins analyses (eg, a degradation of thiamine occurs after 3 days at 4°C or 25°C in PN and vitamin C degradation occurs after 24–48 h at 25°C24 25). Thus, we decided to set the use-by date at 3 days between 2°C and 8°C after the manufacturing process, allowing admixtures to be administered at the end of the third day of storage between 2°C and 8°C and for a period of 24 h at room temperature.…”