Characterization of protein rheology and delivery forces for combination products

Characterization of a proteindevice 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 productcontainer 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. (c) 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:44724480, 2012