Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2485640 | Journal of Pharmaceutical Sciences | 2012 | 9 Pages |
Abstract
Characterization of a protein-device combination product over a wide range of operating parameters defined by end-user requirements is critical for developing a product presentation that is convenient for patient use. In addition to the device components, several product attributes, such as product rheology and product-container interactions, govern the functionality of a delivery system. This article presents results from a characterization study conducted for a high-concentration antibody product in a prefilled syringe. Analytical models are used to study the rheological behavior and to estimate delivery forces over a broad design space comprising temperature, concentration, and shear stress. Data suggest that high-viscosity products may exhibit significant shear thinning under the shear rates encountered under desired injection times.
Keywords
Related Topics
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Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Nitin Rathore, Pratik Pranay, Joseph Bernacki, Bruce Eu, Wenchang Ji, Ed Walls,