Abstract
Purpose
Injection devices for administration of biopharmaceuticals enable subcutaneous self-administration by patients. To meet patient specific capabilities, injection forces need to be characterized. We address the open question of whether tissue resistance significantly contributes to overall injection forces, especially for large injection volumes.
Methods
Subcutaneous tissue resistance was systematically quantified for injection volumes up to 11 mL depending on viscosity (1–20 mPa·s) and injection rates (0.025–0.2 mL/s) using Göttingen Minipigs as the animal model. The contribution of an artificially applied external force at the injection site simulating autoinjector needle cover depression was tested between 2.5–7.5 N.
Results
Tissue resistance reached average values of ~120 mbar for injection volumes up to 11 mL independent of viscosity and injection rate, and maximum values of 300 mbar were determined. Artificially applied external forces led to higher values, independent of the absolute applied force — maximum values of 1 bar were obtained when injecting 4.5 mL of the 20 mPa·s solution at an injection rate of 0.1 mL/s with the application of an artificial 5 N force, corresponding to ~450 mbar. All conditions yield defined injection sites suggesting tissue resistance is defined by mechanical properties of the subcutaneous tissue.
Conclusions
We set our results in relation to overall injection forces, concluding that maximum values in tissue resistance may cause challenges during subcutaneous injection when using injection devices.
Graphical abstract
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30 November 2020
Table 2 of the article ���Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs��� encountered formatting errors in the (original) pdf version with misplacement of text and columns.
Abbreviations
- EFG:
-
External force generator
- i.m.:
-
Intramuscular
- s.c.:
-
Subcutaneous
- SD:
-
Standard deviation
- w/v :
-
Weight per volume
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Allmendinger, A., Fischer, S. Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs. Pharm Res 37, 184 (2020). https://doi.org/10.1007/s11095-020-02906-9
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DOI: https://doi.org/10.1007/s11095-020-02906-9