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Research ArticleResearch

Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality

Liang Fang, Coralie AdÈle Richard, Galen Huaiqiu Shi, Xia Dong, Marissa Rase and Tingting Wang
PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 317-331; DOI: https://doi.org/10.5731/pdajpst.2020.012278
Liang Fang
1West Pharmaceutical Services, Inc., Exton, PA; and
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Coralie AdÈle Richard
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
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Galen Huaiqiu Shi
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
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Xia Dong
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
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Marissa Rase
1West Pharmaceutical Services, Inc., Exton, PA; and
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Tingting Wang
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
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  • For correspondence: wang_tingting@lilly.com
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Abstract

Previous studies have shown that parenteral formulation excipients can interact with the silicone oil in prefilled syringes, thereby causing variations in glide force that affect the performance of autoinjectors. Thus, it is crucial to control the glide force of the prefilled syringes to mitigate the potential risk of dose inaccuracies. This study provided a systematic understanding of the chemical interactions between the excipients, physical interactions between the excipients and the container, as well as their impact on the functional performance of prefilled syringes. The design of experiment approach used in this study generated statistically meaningful data, which confirmed that different excipients caused varying increase in glide force in siliconized prefilled syringes. The data indicated that poloxamer 188 can more effectively maintain stable glide forces during accelerated storage conditions compared with polysorbate 80. This finding was further enhanced using Hansen solubility parameters theory, which provided a fundamental understanding of the mechanisms behind the physical interactions. Chemical stability analysis of the surfactants suggested that degradation of excipients also impacts syringe functionality. In summary, the results revealed the unique interactions between parenteral pharmaceutical excipients and primary packaging systems and the physicochemical foundation behind them.

  • Prefilled syringe
  • Autoinjector
  • Glide force
  • Silicone oil
  • Surfactant
  • Polysorbate
  • Poloxamer
  • Hansen solubility parameters
  • © PDA, Inc. 2021
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PDA Journal of Pharmaceutical Science and Technology: 75 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
Liang Fang, Coralie AdÈle Richard, Galen Huaiqiu Shi, Xia Dong, Marissa Rase, Tingting Wang
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 317-331; DOI: 10.5731/pdajpst.2020.012278

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Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
Liang Fang, Coralie AdÈle Richard, Galen Huaiqiu Shi, Xia Dong, Marissa Rase, Tingting Wang
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 317-331; DOI: 10.5731/pdajpst.2020.012278
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Keywords

  • prefilled syringe
  • Autoinjector
  • Glide force
  • Silicone oil
  • Surfactant
  • Polysorbate
  • Poloxamer
  • Hansen solubility parameters

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