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

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...

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Autores principales:	Francesco Regis, Andrea Arsiccio, Erwan Bourlès, Bernadette Scutellà, Roberto Pisano
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	freezing freeze drying controlled nucleation surface treatment Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/1c172512c4ca4805bfef4801e4f5469b
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spelling	oai:doaj.org-article:1c172512c4ca4805bfef4801e4f5469b2021-11-25T18:40:30ZSurface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing10.3390/pharmaceutics131117661999-4923https://doaj.org/article/1c172512c4ca4805bfef4801e4f5469b2021-10-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1766https://doaj.org/toc/1999-4923Freeze-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.Francesco RegisAndrea ArsiccioErwan BourlèsBernadette ScutellàRoberto PisanoMDPI AGarticlefreezingfreeze dryingcontrolled nucleationsurface treatmentPharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1766, p 1766 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	freezing freeze drying controlled nucleation surface treatment Pharmacy and materia medica RS1-441
spellingShingle	freezing freeze drying controlled nucleation surface treatment Pharmacy and materia medica RS1-441 Francesco Regis Andrea Arsiccio Erwan Bourlès Bernadette Scutellà Roberto Pisano Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
description	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.
format	article
author	Francesco Regis Andrea Arsiccio Erwan Bourlès Bernadette Scutellà Roberto Pisano
author_facet	Francesco Regis Andrea Arsiccio Erwan Bourlès Bernadette Scutellà Roberto Pisano
author_sort	Francesco Regis
title	Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
title_short	Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
title_full	Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
title_fullStr	Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
title_full_unstemmed	Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing
title_sort	surface treatment of glass vials for lyophilization: implications for vacuum-induced surface freezing
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/1c172512c4ca4805bfef4801e4f5469b
work_keys_str_mv	AT francescoregis surfacetreatmentofglassvialsforlyophilizationimplicationsforvacuuminducedsurfacefreezing AT andreaarsiccio surfacetreatmentofglassvialsforlyophilizationimplicationsforvacuuminducedsurfacefreezing AT erwanbourles surfacetreatmentofglassvialsforlyophilizationimplicationsforvacuuminducedsurfacefreezing AT bernadettescutella surfacetreatmentofglassvialsforlyophilizationimplicationsforvacuuminducedsurfacefreezing AT robertopisano surfacetreatmentofglassvialsforlyophilizationimplicationsforvacuuminducedsurfacefreezing
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Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing

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