Study of the addition of L-Carnitine in pediatric parenteral nutrition binary mixtures

S. Renaud, N. Chouaou, D. Reitter, T. Liautaud, L. Sedrati, S. Coulon; Pharmacie à usage Intérieur du Grand Hôpital de l’Est Francilien, site de Marne-La-Vallée, 2-4 cours de la Gondoire, 77600 Jossigny, France

Introduction
The parenteral nutrition (NP) preparation unit of Marne la vallée’s hospital produces with the help of an automaton the binary mixtures intended for the premature babies of the neonatal resuscitation service (RNN) of Meaux’s hospital. L-Carnitine is an essential component for the transport of fatty acids within the mitochondria, the administration of which is recommended by ASPEN for newborns. In the RNN department, the prescribed dose of L-Carnitine is prepared by a nurse and then administered in Y of the binary mixture. This step exposes an increased risk of error and contamination. The objective of this work is to study the influence of the addition of L-Carnitine in the binary mixes produced by the pharmacy.

Objective
Compare the stability of binary NP mixtures in the presence and absence of L-Carnitine.

Materials and Methods
From the analysis of the prescriptions of binary mixtures of NP over 6 months, 3 types of formulas were identified with a different risk of phosphocalcic precipitation. 2 series of 6 bags per formula, 3 without and 3 with L-Carnitine (0.05 mg/mL), were produced and stored at 2 to 8°C for 7 days and then 24 hours at room temperature. The following analyses were performed at D0, D2, D4, D7 and D8: monitoring of sodium, potassium, calcium, magnesium and glucose concentrations as well as measurement of osmolality and pH. Sterility control was performed by the Bactalert® method. The analysis of visible particles was performed by visual control and that of invisible particles by UV-Visible absorbance spectroscopy and dynamic light scattering study.

Results
No visible or invisible particles were identified in our preparations. No variation greater than 10% was measured for all physicochemical analyses for the 3 types of formulations (Ca/P ratios at 0.1, 1 and 2). All preparations passed the sterility test.

Discussion and Conclusion
This study shows that the addition of L-Carnitine does not influence the stability of the 3 formulations performed. The addition of L-Carnitine is thus strongly considered for the preparation of pediatric NP binary mixtures. A 3rd series will be necessary to confirm the reproducibility of our results. A study of the stability of L-Carnitine under these conditions should also complete this work.
This study required numerous technical means and coordination with several services external to the pharmacy.

A.S.P.E.N. position paper: recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Vanek VW, Borum P, Buchman A , et al Nutr Clin Pract 2012;27(4):440-91.

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