Wen Zai-Qing, Vance Aylin, Vega Fabian, Cao Xiaolin, Eu Bruce, Schulthesis Robert
Department of Formulation and Analytical Resources, Amgen Inc., Thousand Oaks, CA 91320, USA.
PDA J Pharm Sci Technol. 2009 Mar-Apr;63(2):149-58.
Prefilled glass syringes (PFSs) have become the most commonly used device for the delivery of recombinant protein therapeutics in parenteral formulations. In particular, auto-injectors preloaded with PFSs greatly facilitate the convenient and efficient self-administration of protein therapeutics by patients. Silicone oil is used as a lubricant in PFSs to facilitate the smooth motion of the plunger during injection. However, there have been few sophisticated analytical techniques that can qualitatively and quantitatively characterize in-situ the morphology, thickness, and distribution of silicone oil in PFSs. In this paper, we demonstrate the application of three optical techniques including confocal Raman microscopy, Schlieren optics, and thin film interference reflectometry to visualize and characterize silicone oil distribution in PFS. The results showed that a container coating process could produce unevenly distributed silicone oil on the glass barrel of PFSs. An insufficiency of the amount of silicone oil on the glass barrel of a PFS can cause stalling when the device is preloaded into an auto-injector. These analytical techniques can be applied to monitor the silicone oil distribution in PFSs.
预填充玻璃注射器（PFSs）已成为肠胃外制剂中递送重组蛋白治疗药物最常用的装置。特别是，预装有PFSs的自动注射器极大地便利了患者方便、高效地自行注射蛋白治疗药物。硅油在PFSs中用作润滑剂，以促进注射过程中柱塞的顺畅移动。然而，几乎没有复杂的分析技术能够原位定性和定量地表征PFSs中硅油的形态、厚度和分布。在本文中，我们展示了三种光学技术的应用，包括共焦拉曼显微镜、纹影光学和薄膜干涉反射测量法，以可视化和表征PFS中硅油的分布。结果表明，容器涂层工艺可能会在PFSs的玻璃筒上产生分布不均匀的硅油。当将PFS预装入自动注射器时，PFS玻璃筒上硅油用量不足会导致卡顿。这些分析技术可用于监测PFSs中硅油的分布。
