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The Quantification of Injectability by Mechanical Testing
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Measuring tissue back-pressure--in vivo injection forces during subcutaneous injection
Andrea Allmendinger1, Robert Mueller, Edward Schwarb
1Late Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Pharmaceutical Research
|December 25, 2014
Summary
Subcutaneous tissue significantly impacts injection forces, increasing with viscosity and injection rate. Local warming in the needle also affects forces during parenteral injections.
Area of Science:
- Pharmacology
- Biomedical Engineering
- Drug Delivery Systems
Background:
- Parenteral injections are common drug delivery routes.
- Understanding in vivo injection forces is crucial for safe and effective drug administration.
- Limited data exists on the contribution of subcutaneous tissue to injection forces.
Purpose of the Study:
- To investigate the role of subcutaneous (sc) tissue in determining injection forces during in vivo administration.
- To quantify the relationship between viscosity, injection rate, and sc tissue back-pressure.
Main Methods:
- In vivo injections were performed on Göttingen minipigs.
- Isotonic dextran solutions with varying viscosities (1-100 mPas) were used.
- Different injection rates (0.025-0.2 mL/s) and volumes (2.5 vs. 4.5 mL) were tested.
Main Results:
- Subcutaneous tissue back-pressure increased linearly with viscosity and injection rate.
- Injection forces ranged from 0.6 ± 0.5 N to 4.7 ± 3.3 N across tested conditions.
- Maximum force reached 12.9 N at 20 mPas and 0.2 mL/s; 6.9 ± 0.3 N at 100 mPas and 0.025 mL/s.
- No significant difference in forces was observed between injection volumes.
- Local warming of the sample in the needle partially compensated for tissue resistance.
Conclusions:
- Subcutaneous tissue contribution must be considered when estimating in vivo injection forces.
- Local warming of the injected substance within the needle influences measured forces.
- Accurate modeling of injection forces requires accounting for both tissue resistance and thermal effects.

