California Institute of Technology, Electrical Engineering, Pasadena, CA 91125, USA.
Amgen Process Development, Thousand Oaks, CA 91320, USA.
J Pharm Sci. 2020 Nov;109(11):3292-3299. doi: 10.1016/j.xphs.2020.07.012. Epub 2020 Jul 15.
Prefilled syringes (PFSs) are commonly used for parenteral delivery of protein therapeutics. In PFSs, the inner surface of the syringe barrel is typically coated with silicone oil for lubrication. The total amount of silicone oil as well as its distribution can impact syringe functionality and particle formation. However, methods to non-destructively characterize the silicone oil distribution are limited. In this paper, we developed a method to visualize and quantify the relative distribution of silicone oil in unfilled syringes using a custom-built multi-color interferometric imaging system. We then applied the system in a preliminary study to investigate the impact of the silicone oil distribution on the number of particles formed in solution after filling and extrusion for two different types of syringes. The syringe type with significantly lower particle counts also exhibited significantly more homogeneous silicone oil distributions. Within syringe types, no significant association was found between silicone oil distribution and particle formation. Our method can be used in further studies that investigate the impact of syringe siliconization on PFS functionality and particle formation.
预充式注射器（PFS）常用于蛋白质治疗药物的肠胃外给药。在 PFS 中，注射器筒的内表面通常涂有硅油以实现润滑。硅油的总量及其分布会影响注射器的功能和颗粒形成。然而，用于非破坏性地描述硅油分布的方法有限。在本文中，我们开发了一种使用定制的多色干涉成像系统可视化和定量未填充注射器中硅油相对分布的方法。然后，我们应用该系统进行了一项初步研究，以考察硅油分布对两种不同类型注射器在填充和挤出后溶液中形成的颗粒数量的影响。颗粒计数明显较低的注射器类型表现出明显更均匀的硅油分布。在注射器类型内，未发现硅油分布与颗粒形成之间存在显著关联。我们的方法可用于进一步研究注射器硅化对 PFS 功能和颗粒形成的影响。
