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

Abstract : INTRODUCTION: 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.
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https://hal.umontpellier.fr/hal-01842440
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Soumis le : mercredi 18 juillet 2018 - 12:06:05
Dernière modification le : mardi 28 mai 2019 - 10:42:02

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L. Tall, Sylvain Lehmann, E. Diouf, C. Gérard, S. Filali, et al.. 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. Annales Pharmaceutiques Françaises, Elsevier Masson, 2015, 73 (1), pp.43 - 59. ⟨10.1016/j.pharma.2014.06.002⟩. ⟨hal-01842440⟩

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