Characterization of protein rheology and delivery forces for combination products

J Pharm Sci. 2012 Dec;101(12):4472-80. doi: 10.1002/jps.23297. Epub 2012 Aug 31.


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.

MeSH terms

  • Antibodies / administration & dosage*
  • Antibodies / chemistry*
  • Drug Delivery Systems / instrumentation
  • Equipment Design
  • Models, Chemical
  • Rheology
  • Syringes
  • Temperature
  • Viscosity


  • Antibodies