Investigation of Fogging Behavior in a Lyophilized Drug Product.
contact angle
glass
lyophilization
monoclonal antibody(s)
protein formulation(s)
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
04
06
2018
revised:
08
10
2018
accepted:
10
10
2018
pubmed:
20
10
2018
medline:
12
5
2020
entrez:
20
10
2018
Statut:
ppublish
Résumé
Vial "fogging" is a common observation in lyophilized biological products and has been reported in the pharmaceutical industry. In addition to unappealing appearance, severe fogging that reaches the shoulder or neck of the vial can potentially compromise the container closure integrity of the vials. In this study, we performed experiments to identify parameters impacting the fogging phenomena in lyophilized drug product vials. Glass vial surface properties were found to have a significant impact on vial fogging. In line with prior published research, the study demonstrates that fogging can be mitigated by using glass vials with hydrophobic surface (such as siliconized vial or TopLyo
Identifiants
pubmed: 30339866
pii: S0022-3549(18)30615-4
doi: 10.1016/j.xphs.2018.10.015
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1101-1109Informations de copyright
Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.