Method to Predict Glass Vial Fogging in Lyophilized Drug Products

Glass fogging is a phenomenon occurring in lyophilized drug products and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic defect; however, the loss of container closure in...

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Bibliographic Details
Published in:	Journal of pharmaceutical sciences Vol. 109; no. 1; p. 323
Main Authors:	Langer, Carolin, Mahler, Hanns-Christian, Koulov, Atanas, Marti, Nicolas, Grigore, Cristina, Matter, Anja, Chalus, Pascal, Singh, Satish, Lemazurier, Thomas, Joerg, Susanne, Mathaes, Roman
Format:	Journal Article
Language:	English
Published:	United States 01-01-2020
Subjects:	Chemistry, Pharmaceutical Drug Compounding Drug Packaging - methods Drug Packaging - standards Freeze Drying Glass - chemistry Hydrophobic and Hydrophilic Interactions Models, Theoretical Pharmaceutical Preparations - chemistry Polysorbates - chemistry Serum Albumin, Bovine - chemistry Surface Properties Transition Temperature formulation process analytical technology (PAT) protein(s) lyophilization biopharmaceutical characterization protein formulation(s)
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