Malkawi Ruba, Altahrawi Lora
Jadara University, Pharmacy Department, P.O.Box 733, Irbid, 21110, Jordan.
Leicester School of Pharmacy, Faculty of Health and Life Sciences, De Montfort University, Leicester, UK.
Saudi Pharm J. 2025 Jul 8;33(4):18. doi: 10.1007/s44446-025-00004-8.
Excipients are important inactive components in drug formulations that ensure stability, bioavailability, and patient compliance. However, emerging evidence suggests that certain excipients, once considered inert, can cause hypersensitivity reactions in certain individuals. Such reactions include mild erythema due to systemic anaphylaxis and create clinical challenges that are difficult to handle. This review presents a systematic review of the existing literature on excipient hypersensitivity, with specific attention paid to commonly implicated excipients such as polyethylene glycol (PEG), parabens, and tartrazine. Hypersensitivity mechanisms (immune-mediated [IgE, T-cell] and non-immune) are discussed, along with their clinical features and diagnostic challenges. In addition, geographic variations in reporting are discussed, which in turn focus on the role of pharmacovigilance in the reduction of risk. Geographic variations in excipient hypersensitivity reporting are also discussed, highlighting disparities in pharmacovigilance efforts across different regions. This review also discusses recent work, regulatory issues, and desensitization protocols for the control of hypersensitivity reactions. Persistent surveillance and individual strategies are needed to enhance patient safety in the context of excipient-induced hypersensitivity.
辅料是药物制剂中重要的非活性成分，可确保药物的稳定性、生物利用度和患者依从性。然而，新出现的证据表明，某些曾被认为是惰性的辅料，可能会在某些个体中引起过敏反应。此类反应包括全身性过敏反应导致的轻度红斑，并带来难以处理的临床挑战。本综述对关于辅料过敏的现有文献进行了系统回顾，特别关注了常见的引发过敏的辅料，如聚乙二醇（PEG）、对羟基苯甲酸酯和酒石黄。文中讨论了过敏机制（免疫介导[IgE、T细胞]和非免疫机制）及其临床特征和诊断挑战。此外，还讨论了报告中的地域差异，进而关注药物警戒在降低风险方面的作用。还讨论了辅料过敏报告中的地域差异，突出了不同地区在药物警戒工作上的差距。本综述还讨论了近期的研究工作、监管问题以及控制过敏反应的脱敏方案。在辅料引起的过敏反应背景下，需要持续监测和个体化策略来提高患者安全性。
