Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.
Citation:
Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.
Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.
Citation:
Anne-Laure Yailian, Céline Serre, Justine Fayard, Marina Faucon, Patrick Thomaré, Samira Filali, Christine Pivot, Florence Vételé, Fabrice Pirot, Emmanuelle Olivier. Production and stability study of a hospital parenteral nutrition solution for neonates[J]. Journal of Pharmaceutical Analysis, 2019, 9(2): 83-90.
Service Pharmaceutique, Plateforme Fripharm, Groupe Hospitalier Centre Edouard Herriot, Hospices Civils de Lyon, 5, Place d'Arsonval, F-69437 Lyon cedex 03, France
Laboratoire de Recherche et Développement de Pharmacie Galénique Industrielle, UMR 5305, Plateforme Fripharm, Faculté de Pharmacie, Université Claude Bernard Lyon 1, 8, avenue Rockefeller, F-69373 Lyon Cedex 08, France
Service Pharmaceutique, Site H?tel-Dieu, Centre Hospitalo-Universitaire de Nantes, 1, place Alexis Ricordeau, F-44093 Nantes Cedex 01, France
Service pharmaceutique, Groupement Hospitalier Est, Hospices Civils de Lyon, 59 boulevard Pinel, F-69677 Bron cedex, France
Standard parenteral nutrition solutions are mixtures comprising interacting components that may de-grade themselves over time. The objective of this study was to investigate the physicochemical and microbiological stability of a hospital preparation for parenteral nutrition in neonatology. The analyses were performed throughout the storage of the preparations at 2–8 °C (up to 4 months). The extent of stability was based on the determination of amino acids dosage, visual and physicochemical properties (glucose and electrolytes concentrations, pH and osmolality measurements, particle counting) and mi-crobiological analysis (sterility test). A thermal degradation of ascorbic acid was conducted to evaluate the antioxidant properties of the parenteral mixture. Physicochemical and microbiological controls were found to comply with the specifications. Amino acids showed a good stability throughout the 4months storage except for cysteine, which was progressively degraded to cystine, conferring a yellow coloration to parenteral solutions. Parenteral nutrition standards solutions remain stable for 4 months at 2–8 °C, ensuring safe administration in preterm infants.