[Aseptic process validation and stability study of an injectable preparation of fructose (5%)-glycerol (10%) as part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract].
BACKGROUND
As part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract, a new hospital sterile and non-pyrogenic preparation of fructose (5%)-glycerol (10%) was realized. Under pharmaceutical legislation, the provision of this hospital preparation involves of aseptic process validation and achieve a stability study.


METHODS
After the aseptic process validation with Mediafill Test, the preparation was made under aseptic conditions associated with a sterilizing filtration according to the good practices preparation. Prepared flexible bags (100mL of solution) were stored for one year in a climatic chamber (25±2°C). To assess stability, the physicochemical controls (fructose concentration, glycerol concentration, hydroxy-methyl-5 furfural [5-HMF] concentration, sodium concentration, pH measure, osmolality and sub-visible particles count) and microbiological (bioburden, bacterial endotoxin and sterility) were performed at regular intervals for one year.


RESULTS
Neither significant decrease of fructose concentration, glycerol concentration and sodium concentration nor pH, 5-HMF, osmolality variations out of specifications were observed for one year. The sub-visible particles count, the bacterial endotoxin and sterility were in accordance with the European pharmacopoeia attesting limpidity, apyrogenicity and sterility of this injectable preparation.


CONCLUSIONS
The hospital preparation was stable over one year at 25±2°C, ensuring safe administration in humans within the framework of this clinical research.
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France. Electronic address: mamadou-lamine.tall@chu-lyon.fr.
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Tall
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France; 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.
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Salmon
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Diouf
Laboratoire de biochimie, centre hospitalier Lyon-Sud, hospices civils de Lyon, 69495 Pierre-Bénite, France; Inserm U1060, laboratoire CarMeN, université Claude Bernard Lyon-1, 69921 Oullins, France.
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Drai
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Filali
Service d'hépato-gastro-entérologie, groupement hospitalier Édouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Lépilliez
Service d'hépato-gastro-entérologie, groupement hospitalier Édouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Pioche
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Laleye
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Dhelens
Service d'hépato-gastro-entérologie, groupement hospitalier Édouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Ponchon
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
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Pivot
Service pharmaceutique, plateforme FRIPHARM, groupement hospitalier Edouard Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France; 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.
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Pirot
D002277:Carcinoma / Q000188:drug therapy; D004355:Drug Stability; D004356:Drug Storage; D004724:Endoscopy; D005632:Fructose / Q000008:administration & dosage* / Q000737:chemistry; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy; D005990:Glycerol / Q000008:administration & dosage* / Q000737:chemistry; D015203:Reproducibility of Results; D013242:Sterilization
D005632:Fructose; D005990:Glycerol
Clinical research; Endoscopic cure; Fructose; Glycerol; Glycérol; Hospital preparation; Lésions néoplasiques épithéliales; Neoplastic epithelial lesions; Préparation hospitalière; Recherche clinique; Stability study; Traitement curatif endoscopique; Étude de stabilité