RT Journal Article
SR Electronic
T1 Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 317
OP 331
DO 10.5731/pdajpst.2020.012278
VO 75
IS 4
A1 Liang Fang
A1 Coralie AdÈle Richard
A1 Galen Huaiqiu Shi
A1 Xia Dong
A1 Marissa Rase
A1 Tingting Wang
YR 2021
UL http://journal.pda.org/content/75/4/317.abstract
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.