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

Annales pharmaceutiques françaises
M L TallF Pirot

Abstract

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. 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. 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 parti...Continue Reading

References

Mar 23, 2002·Forensic Science International : Synergy·Akiko KiyoshimaNoriaki Ikeda
Apr 15, 2004·JPEN. Journal of Parenteral and Enteral Nutrition·Antònia BaletMa Antònia Mangues
Sep 29, 2009·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Ryan A FrielerThad A Rosenberger
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Apr 5, 2011·Molecular Nutrition & Food Research·Klaus AbrahamKlaus E Appel
Jan 17, 2012·Biochemical and Biophysical Research Communications·Hideyuki TomitoriKeiko Kashiwagi

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Citations

Apr 19, 2016·United European Gastroenterology Journal·Maximilien BarretFrédéric Prat

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