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Barrier properties and hydrothermal aging of amorphous alumina coatings applied on pharmaceutical vials

Etchepare, Pierre-Luc and Samélor, Diane and Vergnes, Hugues and Caussat, Brigitte and Vahlas, Constantin Barrier properties and hydrothermal aging of amorphous alumina coatings applied on pharmaceutical vials. (2021) Surface and Coatings Technology, 425. 127711. ISSN 0257-8972

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Official URL: https://doi.org/10.1016/j.surfcoat.2021.127711

Abstract

Actual requirements of the pharmaceutics industry for reliable, safe, long term storage of biopharmaceuticals imply the use of chemically inert glass vials. This can be achieved by applying a barrier coating on their internal surface. In the present work we investigate the hydrolytic resistance of amorphous alumina coatings applied by chemical vapor deposition at the interior of soda lime glass containers. Autoclaving for 60 min at 121 °C and 2 bar absolute pressure of water filled such containers according to normed tests defined by the European Pharmacopeia, reveal that the concentrations of extractables obtained from the glass and released into the solution in contact, are low. The acidification of the water inside the bottle leads to the partial delamination of a 300 nm thick alumina coating and results in a significant release of aluminum ions. This is due to the previously identified alteration of the external part of the film. In contrast, alumina layers thinner than 20 nm, show concentrations of extractables, both glass and aluminum ions, that are significantly lower than those of an uncoated bottle. This preliminary result is particularly promising. It is attributed to the transformation of the nanometric alumina coating into an aluminosilicate interdiffusion layer during the deposition process, which acts as an efficient barrier, while remaining unaffected from the interaction with the content during the shelf life of the drug.

Item Type:Article
Audience (journal):International peer-reviewed journal
Uncontrolled Keywords:
Institution:French research institutions > Centre National de la Recherche Scientifique - CNRS (FRANCE)
Université de Toulouse > Institut National Polytechnique de Toulouse - Toulouse INP (FRANCE)
Université de Toulouse > Université Toulouse III - Paul Sabatier - UT3 (FRANCE)
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Deposited On:05 Nov 2021 13:45

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