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Using First Principles to Link Silicone Oil/Formulation Interfacial Tension With Syringe Functionality in Pre-Filled
Coralie A Richard1, Tingting Wang2, Sarah L Clark1
1Delivery Device and Connected Solutions, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Journal of Pharmaceutical Sciences
|June 23, 2020
Summary
Lower interfacial tension between silicone oil and drug formulations in pre-filled syringes increases glide force. Polysorbate 80 in formulations can remove silicone oil from the syringe barrel.
Area of Science:
- Materials Science
- Biomedical Engineering
- Physical Chemistry
Background:
- Interactions at the glass barrel/silicone oil coating/aqueous formulation interface in pre-filled syringes can impact device functionality.
- Silicone oil is used as a lubricant in pre-filled syringes, but its interactions with drug formulations are complex.
- Understanding these interfacial phenomena is crucial for ensuring consistent and reliable drug delivery.
Purpose of the Study:
- To apply the Young-Dupré equation to quantify interfacial tension at the silicone oil/aqueous formulation interface.
- To correlate interfacial tension with pre-filled syringe functionality, specifically glide force.
- To investigate the relationship between glide force profiles and silicone oil film thickness post-injection.
Main Methods:
- Utilized the Young-Dupré equation to model interfacial tension.
- Measured syringe glide force as a key functional parameter.
- Analyzed silicone oil film thickness and distribution after injection using various techniques.
Main Results:
- A lower silicone oil/drug product formulation interfacial tension was correlated with an increased syringe glide force.
- Glide force profiles were directly related to the silicone oil thickness remaining in the syringe barrel.
- Formulations containing polysorbate 80 demonstrated removal of silicone oil from the syringe barrel end post-injection.
Conclusions:
- Interfacial tension is a critical factor influencing the performance of pre-filled syringes.
- Drug formulation composition, such as the presence of polysorbate 80, significantly affects silicone oil behavior and syringe functionality.
- Optimizing silicone oil and formulation interactions is essential for developing robust and reliable pre-filled syringe systems.
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