Stability study of injectable preparation used in neonatology

ML. Tall1*, E. Diouf1, S. Haÿs2,3, B. Ducarre1, M. Lenfant1, M. Bador1, N. Koog1, D. Salmon1,4, F. Pirot1,4, C. Pivot1 1 Pharmacie, Groupement Hospitalier Edouard Herriot, 5 place d’Arsonval, 69437 Lyon cedex 03, France
2 Service de Néonatologie et Réanimation néonatale, Groupement Hospitalier Nord, 103 grande rue de la Croix Rousse 69317 Lyon cedex 04, France
3 Centre de Recherche en Nutrition Humaine, Rhône Alpes, Groupement Hospitalier Sud, 165 chemin du Grand Revoyet, 69495 Pierre-Bénite Cedex, France
4 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

Coordonnées de l’auteur de correspondance* :
Groupement Hospitalier Edouard Herriot, Service Pharmaceutique, 5 place d’Arsonval, 69437 Lyon cedex 03, France
E-mail: mamadou-lamine.tall@chu-lyon.fr
Phone number: +33 4.72.11.78.94
Fax number: + 33 4.72.11.78.76

Introduction

This prepapration is specifically indicated in neonatology (i) to enhance glucose uptake in glucose intolerant patients and (ii) to adapt hydric needs regarding intakes from total parenteral nutrition mixture. To meet regulatory requirements and have ready to use prepartion with an expiration date, a stability study was realised for 1 year.

Materials and method

This hospital preparation was made under aseptic conditions associated with a sterilizing filtration and autoclaving. The sterile solution has been conditioned in 50 ml glass type II bottle containing in galenic formulation 138,8 mM of glucose and 35,1 mM of sodium chloride. Prepared bottles were stored at 22 ± 3°C in a dry place.
To assess stability, the physical-chemicals controls (pH, osmolality, sodium, chlorides, sub-visible particles, glucose and hydroxy-methyl-furfural (5HMF: glucose degradation product)) and microbiologicals (bacterial endotoxins and sterility) were realized from a pilot batch of 100 bottles.

Results and discussion

Neither significant decrease of glucose concentration and sodium concentration nor pH and osmolality variation were observed for 1 year study. Throughout the study, the content of 5-HMF, remained below the concentration harmful for Human. The sub-visible particles, the bacterial endotoxin and sterility were in accordance with the European Pharmacopoeia attesting limpidity, apyrogenicity and sterility of this injectable preparation.

Conclusion

the injectable preparation was stable over 1 year at 22 ± 3°C, ensuring to safe for intravenous administration for prematures.

Key words: sterile hospital preparation; stability study; neonatology ; adaptaion of hydric needs; glucose intolerance.

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