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Préparation injectable de leucine marquée au carbone 13 pour un programme de recherche clinique sur la maladie d’Alzheimer : contrôle pharmaceutique des matières premières et du produit fini et étude de stabilité

By L. Tall, Sylvain Lehmann, E. Diouf, C. Gérard, S. Filali, Audrey Gabelle, Christophe Hirtz, L. Gabert, V. Sauvinet, F. Pirot and C. Pivot

Abstract

International audienceINTRODUCTION:The L-leucine labeled (L-[U-(13)C] Leu) is a stable isotopic tracer administered by parenteral route within the framework of a new clinical research program concerning the diagnosis of the Alzheimer's disease. To meet regulatory requirements and have ready to use solution with an expiration date, a pharmaceutical control of raw materials and the finished product followed by a stability study were realised.MATERIALS AND METHOD:After the pharmaceutical control of raw materials, the solution of L-[U-(13)C] Leu was prepared according to the good practices preparation. Prepared bottles were stored for 1 year of a share in a climatic chamber (25 °C±2 °C) and the other in a refrigerator (5 °C±3 °C). To assess stability, the physicochemical controls (pH, osmolality, sub-visible particles, L-[U-(13)C] Leu concentration, sodium concentration, isotopic enrichment) and microbiological (bacterial endotoxin and sterility) were performed at regular intervals for 1 year.RESULTS:Neither significant decrease of L-[U-(13)C] Leu concentration and sodium concentration nor pH and osmolality variation were observed for 1 year. Isotopic enrichment higher than 99.9% reflected the stability of labelling of L-leucine molecule. 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.DISCUSSION AND CONCLUSION:The injectable preparation of L-[U-(13)C] Leu was stable after 1 year for two preservation conditions, ensuring to safety for administration for human within the framework of this clinical research

Topics: [SDV]Life Sciences [q-bio]
Publisher: 'Elsevier BV'
Year: 2015
DOI identifier: 10.1016/j.pharma.2014.06.002
OAI identifier: oai:HAL:hal-01842440v1
Provided by: HAL-HCL
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