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Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs.

Andrea Allmendinger1, Stefan Fischer2

  • 1Pharmaceutical Development & Supplies Biologics Europe, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland. andrea.allmendinger.aa1@roche.com.

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Summary

Subcutaneous tissue resistance was quantified for large-volume biopharmaceutical injections. High tissue resistance, especially with external forces, can challenge subcutaneous injection device performance.

Keywords:
auto-injectorhighly concentrated protein formulationsinjection deviceinjection forceprefilled syringesubcutaneous drug administration

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Area of Science:

  • Biomedical Engineering
  • Pharmacology
  • Materials Science

Background:

  • Subcutaneous self-administration of biopharmaceuticals is common.
  • Characterizing injection forces is crucial for patient-specific device design.
  • The contribution of tissue resistance to injection forces remains unclear, particularly for large volumes.

Purpose of the Study:

  • To investigate the impact of subcutaneous tissue resistance on injection forces.
  • To determine if tissue resistance significantly contributes to overall injection forces for large volumes.
  • To assess the influence of viscosity, injection rate, and external forces on tissue resistance.

Main Methods:

  • Quantified subcutaneous tissue resistance in Göttingen Minipigs for volumes up to 11 mL.
  • Varied viscosity (1-20 mPa·s) and injection rates (0.025-0.2 mL/s).
  • Applied external forces (2.5-7.5 N) to simulate autoinjector needle cover depression.

Main Results:

  • Tissue resistance averaged ~120 mbar for volumes up to 11 mL, independent of viscosity and rate.
  • Maximum tissue resistance reached 300 mbar.
  • External forces increased resistance, with a 5 N force yielding ~450 mbar for 4.5 mL of high-viscosity solution.

Conclusions:

  • Subcutaneous tissue resistance can be significant, potentially challenging injection device performance.
  • Mechanical properties of subcutaneous tissue define resistance.
  • Understanding tissue resistance is vital for optimizing subcutaneous injection devices for large biopharmaceutical volumes.