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Article

Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing

1
Department of Applied Science and Technology, Politecnico di Torino, 24 Corso Duca degli Abruzzi, 10129 Torino, Italy
2
GSK Vaccines, 89 Rue de l’Institut, 1330 Rixensart, Belgium
*
Author to whom correspondence should be addressed.
Academic Editor: Afzal R. Mohammed
Pharmaceutics 2021, 13(11), 1766; https://doi.org/10.3390/pharmaceutics13111766
Received: 14 September 2021 / Revised: 15 October 2021 / Accepted: 20 October 2021 / Published: 22 October 2021
(This article belongs to the Special Issue New Trends in Freeze-Drying of Pharmaceutical Products)
Freeze-drying is commonly used to increase the shelf-life of pharmaceuticals and biopharmaceuticals. Freezing represents a crucial phase in the freeze-drying process, as it determines both cycle efficiency and product quality. For this reason, different strategies have been developed to allow for a better control of freezing, among them, the so-called vacuum-induced surface freezing (VISF), which makes it possible to trigger nucleation at the same time in all the vials being processed. We studied the effect of different vial types, characterized by the presence of hydrophilic (sulfate treatment) or hydrophobic (siliconization and TopLyo Si–O–C–H layer) inner coatings, on the application of VISF. We observed that hydrophobic coatings promoted boiling and blow-up phenomena, resulting in unacceptable aesthetic defects in the final product. In contrast, hydrophilic coatings increased the risk of fogging (i.e., the undesired creeping of the product upward along the inner vial surface). We also found that the addition of a surfactant (Tween 80) to the formulation suppressed boiling in hydrophobic-coated vials, but it enhanced the formation of bubbles. This undesired bubbling events induced by the surfactant could, however, be eliminated by a degassing step prior to the application of VISF. Overall, the combination of degasification and surfactant addition seems to be a promising strategy for the successful induction of nucleation by VISF in hydrophobic vials. View Full-Text
Keywords: freezing; freeze drying; controlled nucleation; surface treatment freezing; freeze drying; controlled nucleation; surface treatment
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MDPI and ACS Style

Regis, F.; Arsiccio, A.; Bourlès, E.; Scutellà, B.; Pisano, R. Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing. Pharmaceutics 2021, 13, 1766. https://doi.org/10.3390/pharmaceutics13111766

AMA Style

Regis F, Arsiccio A, Bourlès E, Scutellà B, Pisano R. Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing. Pharmaceutics. 2021; 13(11):1766. https://doi.org/10.3390/pharmaceutics13111766

Chicago/Turabian Style

Regis, Francesco, Andrea Arsiccio, Erwan Bourlès, Bernadette Scutellà, and Roberto Pisano. 2021. "Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing" Pharmaceutics 13, no. 11: 1766. https://doi.org/10.3390/pharmaceutics13111766

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