Bristol-Myers Squibb, Co., 1 Squibb Dr, New Brunswick, NJ, 08901 USA.
Sanofi, 13 quai Jules Guesde, 94400 Vitry-Sur-Seine, France.
Adv Drug Deliv Rev. 2024 Jun;209:115301. doi: 10.1016/j.addr.2024.115301. Epub 2024 Apr 2.
Subcutaneous (SC) injections can be associated with local pain and discomfort that is subjective and may affect treatment adherence and overall patient experience. With innovations increasingly focused on finding ways to deliver higher doses and volumes (≥2 mL), there is a need to better understand the multiple intertwined factors that influence pain upon SC injection. As a priority for the SC Drug Development & Delivery Consortium, this manuscript provides a comprehensive review of known attributes from published literature that contribute to pain/discomfort upon SC injection from three perspectives: (1) device and delivery factors that cause physical pain, (2) formulation factors that trigger pain responses, and (3) human factors impacting pain perception. Leveraging the Consortium's collective expertise, we provide an assessment of the comparative and interdependent factors likely to impact SC injection pain. In addition, we offer expert insights and future perspectives to fill identified gaps in knowledge to help advance the development of patient-centric and well tolerated high-dose/high-volume SC drug delivery solutions.
皮下（SC）注射可能会引起局部疼痛和不适，这种疼痛和不适是主观的，可能会影响治疗的依从性和整体患者体验。随着创新越来越关注寻找方法来提供更高的剂量和体积（≥2 毫升），因此有必要更好地了解影响 SC 注射疼痛的多种相互交织的因素。作为 SC 药物开发和输送联盟的首要任务，本文稿从三个角度全面回顾了已发表文献中已知的导致 SC 注射疼痛/不适的属性：（1）导致身体疼痛的设备和输送因素，（2）引发疼痛反应的配方因素，以及（3）影响疼痛感知的人为因素。利用联盟的集体专业知识，我们对可能影响 SC 注射疼痛的比较和相互依赖的因素进行了评估。此外，我们还提供了专家的见解和未来的观点，以填补知识空白，帮助推进以患者为中心且耐受良好的高剂量/大容量 SC 药物输送解决方案的开发。
