PT  - JOURNAL ARTICLE
AU  - Liang Fang
AU  - Coralie AdÈle Richard
AU  - Galen Huaiqiu Shi
AU  - Xia Dong
AU  - Marissa Rase
AU  - Tingting Wang
TI  - Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
AID  - 10.5731/pdajpst.2020.012278
DP  - 2021 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 317--331
VI  - 75
IP  - 4
4099  - http://journal.pda.org/content/75/4/317.short
4100  - http://journal.pda.org/content/75/4/317.full
SO  - PDA J Pharm Sci Technol2021 Jul 01; 75
AB  - 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.