JOURNAL OF ASIAN ASSOCIATION OF SCHOOLS OF PHARMACY - Volume 1 No.3, July - September, 2012

Pages: 152-158
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Stability of trace elements and vitamin-containing TPN admixture of in a multi-chamber bag (Fulcaliq)

Author: Yuko Okuyama, Takeshi Akiyoshi, Toru Asayama, Masami Hirai, Kenji Matsuyama, Hisakazu Ohtani

Category: Pharmacy

Abstract:

A multi-chamber for total parenteral nutrition (TPN), Fulcaliq®, which is convenient for mixing of liquids from 3 chambers, was stability evaluated in clinical setting when exposed to trace elements up to 14 days. Branded or generic formulations of trace elements were compared in 3 groups: 1) glucose solution + trace elements, 2) a mixture of glucose solution and amino acid solution (Mixture A) + trace elements and 3) the 3 solutions (Mixture B) + trace elements. Stability was assessed visually and by means of pH measurement and UV-vis spectrophotometry. In all samples, no suspension or particles were visually identified and the pH remained within the controlled range of Fulcaliq itself. With regard to the color and absorbance, the glucose solution spiked with trace elements remained unchanged up to Day 14, Mixture A and Mixture B spiked with trace elements started to change from Day 7. The same results were observed upon spiking with a generic drug instead of a branded one as trace elements. For the glucose solution spiked with trace elements, unless not mixed with other solution(s), it is not crucial to mix the trace elements just before use, and it can be prepared and supplied weekly.

Keywords: Multi-chamber bag stability parenteral nutrition trace elements vitamin