Study of the impact of a multi coat packaging on the stability of the parenteral nutrition mixtures

D. Laleye1, P. Cerf1, A. Traoré1, W. Mos1, ML. Tall1, E. Diouf1, C. Barreto1, F. Pirot1,2, C. Pivot1 1 Pharmacie, Groupement Hospitalier Edouard Herriot, 5 place d’Arsonval, 69437 Lyon cedex 03, France
2 Laboratoire de Recherche et développement de Pharmacie Galénique Industrielle,
Faculté de Pharmacie, EA 4169 "Fonctions Physiologiques et Pathologiques de la Barrière Cutanée",
Université Claude Bernard Lyon 1, 8 avenue Rockefeller, 69373 Lyon cedex 08, France

Introduction

Preparations of parenteral nutrition realized by the hospital pharmacy for the patients at home are conditioned in supple EVA bags and packed in mono coat, transparent plastic zipped bags .The implementation of a new packaging (triple coat polyester aluminum polyethylene opaque white bag) a study of stability was realized.

Material and method

The used packaging is a triple coat bag opaque to the light, anti-UV rays, impervious to water and oxygen. From usual prescriptions, six formulae of mixtures were realized in aseptic conditions in class A and according to << Bonnes Pratiques de Préparation >>: 3 pediatric formulae and 3 adult formulae distributed in low, medium and high according to the increasing concentration of calcium ion. For each formula 5 bags of nutrition mixture were prepared (N=30), then packed in the triple coat packaging and stored in the refrigerator. To appraise the stability of prepared nutrition mixture, physic-chemical (macroscopic aspect, Na, K, Mg, Ca, osmolality) and microbiological (endotoxin and tests of germs contamination) analyses were made on days 0, 7, 14, 21, 35.

Results and discussion

The results of the physic-chemical analyses showed no significant differences compared with day 0. The microbiological analyses up to date 0 were in conformity with our specifications. A further study to assess the efficiency of this triple coat packaging on the stability of vitamins, amino acids will strengthen the results of this study.

Conclusion

This study allowed to demonstrate the interest of a multi coat packaging on physic-chemical stability of parenteral nutrition mixtures. This stability allows to ensure the quality of parenteral nutrition mixtures, to improve the logistics of transports in terms of number of home deliveries of bags of parenteral nutrition mixture and to anticipate the preparations for the stable patients.

Key Words : Parenteral nutrition mixtures, packaging, Stability.

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