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Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
Liang Fang1, Coralie AdÈle Richard2, Galen Huaiqiu Shi2
1West Pharmaceutical Services, Inc., Exton, PA; and.
PDA Journal of Pharmaceutical Science and Technology
|January 16, 2021
Summary
Controlling glide force in prefilled syringes is vital for accurate drug delivery. This study reveals how pharmaceutical excipients interact with syringe components, impacting force and stability.
Area of Science:
- Pharmaceutical Science
- Materials Science
- Chemical Engineering
Background:
- Parenteral formulation excipients can interact with silicone oil in prefilled syringes.
- These interactions cause glide force variations, potentially leading to autoinjector performance issues and dose inaccuracies.
Purpose of the Study:
- To systematically understand chemical and physical interactions between pharmaceutical excipients and prefilled syringe components.
- To investigate the impact of these interactions on the functional performance of prefilled syringes.
- To identify excipients that maintain stable glide forces under storage conditions.
Main Methods:
- Utilized a design of experiments approach to generate statistically significant data.
- Applied Hansen solubility parameters theory to elucidate physical interaction mechanisms.
- Conducted chemical stability analysis of surfactants.
Main Results:
- Different excipients significantly increased glide force in siliconized prefilled syringes.
- Poloxamer 188 demonstrated superior ability to maintain stable glide forces compared to polysorbate 80 during accelerated storage.
- Excipient degradation was identified as a factor affecting syringe functionality.
Conclusions:
- Parenteral pharmaceutical excipients exhibit unique interactions with primary packaging systems.
- Understanding these physicochemical interactions is crucial for optimizing prefilled syringe design and performance.
- Excipient selection and stability are key to ensuring consistent drug delivery from prefilled syringes.
Keywords:
AutoinjectorGlide forceHansen solubility parametersPoloxamerPolysorbatePrefilled syringeSilicone oilSurfactantMore Related Videos
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