注射器
医学
材料科学
硅酮
生物医学工程
复合材料
机械工程
工程类
作者
Liang Fang,Galen Shi,Coralie A. Richard,Xia Dong,Justin C. Thomas,Michael C. Victor,Tingting Wang,Sharon Shinkle,Cathy Zhao
出处
期刊:Pda Journal of Pharmaceutical Science and Technology
[Parenteral Drug Association, Inc.]
日期:2020-01-01
卷期号:74 (6): 674-687
被引量:5
标识
DOI:10.5731/pdajpst.2020.011627
摘要
Given the surging interest in developing prefilled syringe and autoinjector combination products, investment in an early compatibility assessment is critical to prevent unwarranted drug/container closure interactions and avoid potential reformulation during late stages of drug development. In addition to the standard evaluation of drug stability, it is important to consider container closure functionality and overall device performance changes over time because of drug–container closure component interaction. This study elucidated the mechanisms that cause changes in syringe glide force over time and the impact on the injection duration. It was an expansion of the previous work, which indicated that drug formulation variables such as formulation excipients and pH affect syringe functionality over time. The current study described an investigative process for troubleshooting prolonged and variable autoinjector injection time caused by an increased syringe glide force variability over time. This increase in glide force variability stems from two root causes, namely plunger dimensional variation and syringe silicone oil change over time. The results demonstrated (a) the underlying factors of silicone oil change in the presence of drug formulation matrices, (b) accelerated stability of syringe glide force as a good indicator of long-term, real-time stability, and (c) that buffer matrix-filled syringes can be used to predict the syringe functionality and stability of drug product-filled syringes. Based on the experimental findings of a variety of orthogonal characterization techniques including contact angle, interfacial tension, and calculation of Hansen solubility parameters, it is proposed that silicone oil change is caused by formulation excipients and a complex set of phenomena summarized as “wet, wash, and delube” processes.
科研通智能强力驱动
Strongly Powered by AbleSci AI