ISSN 2286-6493
Journal of Asian Association of Schools of Pharmacy

Stability of trace elements and vitamin-containing TPN admixture of in a multi-chamber bag (Fulcaliq)  Research Article 

Yuko Okuyama1, Takeshi Akiyoshi2, Toru Asayama1, Masami Hirai3, Kenji Matsuyama4 and Hisakazu Ohtani2
1 Department of Pharmacy, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
2 Department of Clinical Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan.
3 Department of Clinical Pharmaceutics, Kyusyu University of Health and Welfare, 1714-1 Yoshinomachi Nobeoka, Miyazaki 882-8508, Japan.
4 Department of Division for Clinical Pharmacy, School of Pharmacy, Kinki University, 3-4-1 Kowakae, Higashiosaka, Osaka 577-8502, Japan


    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.  


1 Multi-chamber bag
2 stability parenteral nutrition
3 trace elements vitamin

Published in

JAASP Volume 1 No. 3
July - September, 2012

Page: 152-158

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