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Development of an advanced injection time model for an autoinjector
Thomas Thueer1, Lena Birkhaeuer1, Declan Reilly1
1Device Development, Pharma Technical Development Europe, F. Hoffmann-La Roche Ltd, Basel, Switzerland, thomas.thueer@roche.com.
A new physics-based model accurately predicts autoinjector injection time, crucial for drug delivery device development. This validated model uses statistical variables and Monte Carlo simulation to assess injection time probabilities.
Area of Science:
- Biomedical Engineering
- Pharmaceutical Technology
Background:
- Autoinjectors are critical for parenteral drug delivery.
- Accurate prediction of injection time is essential for autoinjector development and commercialization.
Purpose of the Study:
- To develop and validate an advanced physics-based mathematical model for predicting autoinjector injection time.
- To quantify the probability of achieving desired injection times.
Main Methods:
- Modeled injection time parameters as statistical variables with distribution functions.
- Employed Monte Carlo simulation to determine injection time probabilities.
- Conducted experimental validation with autoinjector testing.
Main Results:
- Demonstrated excellent agreement between modeled and measured injection times.
- Achieved modeling errors below 12% across various device configurations.
- Identified a slight model bias potentially due to internal friction.
Conclusions:
- The developed model is accurate, computationally inexpensive, and suitable for statistical simulations.
- The model effectively determines expected injection time ranges considering component variability.
- Validated approach supports robust autoinjector design and development.
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