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Towards more tolerable subcutaneous administration: Review of contributing factors for improving combination product design
Advanced Drug Delivery Reviews ( IF 15.2 ) Pub Date : 2024-04-02 , DOI: 10.1016/j.addr.2024.115301 Neil Mathias 1 , Sylvain Huille 2 , Marie Picci 3 , Robert P Mahoney 4 , Ronald J Pettis 5 , Brian Case 6 , Bernhard Helk 7 , David Kang 8 , Ronak Shah 1 , Junchi Ma 9 , Deep Bhattacharya 10 , Yogita Krishnamachari 11 , Dany Doucet 12 , Nathalie Maksimovikj 2 , Sahab Babaee 13 , Patrick Garidel 14 , Reza Esfandiary 15 , Rajesh Gandhi 1
Advanced Drug Delivery Reviews ( IF 15.2 ) Pub Date : 2024-04-02 , DOI: 10.1016/j.addr.2024.115301 Neil Mathias 1 , Sylvain Huille 2 , Marie Picci 3 , Robert P Mahoney 4 , Ronald J Pettis 5 , Brian Case 6 , Bernhard Helk 7 , David Kang 8 , Ronak Shah 1 , Junchi Ma 9 , Deep Bhattacharya 10 , Yogita Krishnamachari 11 , Dany Doucet 12 , Nathalie Maksimovikj 2 , Sahab Babaee 13 , Patrick Garidel 14 , Reza Esfandiary 15 , Rajesh Gandhi 1
Affiliation
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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.
中文翻译：
实现更耐受的皮下给药：审查改进组合产品设计的影响因素
皮下 (SC) 注射可能会导致主观的局部疼痛和不适，并可能影响治疗依从性和整体患者体验。随着创新越来越注重寻找提供更高剂量和体积（≥2 mL）的方法，需要更好地了解影响皮下注射疼痛的多个相互交织的因素。作为 SC 药物开发和递送联盟的优先事项，本手稿从三个角度对已发表文献中导致 SC 注射时疼痛/不适的已知属性进行了全面回顾：(1) 导致身体疼痛的设备和递送因素，( 2）触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，我们对可能影响皮下注射疼痛的比较因素和相互依存因素进行了评估。此外，我们还提供专家见解和未来前景，以填补已发现的知识空白，帮助推进以患者为中心且耐受性良好的高剂量/大容量 SC 给药解决方案的开发。
更新日期：2024-04-02
中文翻译：
实现更耐受的皮下给药：审查改进组合产品设计的影响因素
皮下 (SC) 注射可能会导致主观的局部疼痛和不适，并可能影响治疗依从性和整体患者体验。随着创新越来越注重寻找提供更高剂量和体积（≥2 mL）的方法，需要更好地了解影响皮下注射疼痛的多个相互交织的因素。作为 SC 药物开发和递送联盟的优先事项，本手稿从三个角度对已发表文献中导致 SC 注射时疼痛/不适的已知属性进行了全面回顾：(1) 导致身体疼痛的设备和递送因素，( 2）触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，我们对可能影响皮下注射疼痛的比较因素和相互依存因素进行了评估。此外，我们还提供专家见解和未来前景，以填补已发现的知识空白，帮助推进以患者为中心且耐受性良好的高剂量/大容量 SC 给药解决方案的开发。
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