Graduate Program in Veterinary Sciences, Center for Agricultural Sciences and Engineering - CCAE, Federal University of Espírito Santo - UFES, Alegre, ES, 29500-000, Brazil.
Pharmaceutical Product Development Laboratory, Center of Exact, Natural and Health Sciences - CCENS, Federal University of Espírito Santo - UFES, Alegre, ES, 29500-000, Brazil.
Daru. 2024 Jun;32(1):289-305. doi: 10.1007/s40199-023-00486-8. Epub 2023 Oct 31.
Veterinarians and pharmacists are familiar with the efficacy and safety aspects attributed to active pharmaceutical ingredients included in medicines, but they are rarely concerned with the safety of excipients present in medicines. Although generally recognized as safe, excipients are not chemically inert and may produce adverse events in certain animal populations. This review aims to present excipients of concern to these populations and highlight their relevance for rational veterinary pharmacotherapy.
A comprehensive review of the literature about the existence of adverse reactions in animals caused by pharmaceutical excipients was carried out based on an exploratory study. An overview of the correct conditions of use and safety of these excipients has also been provided, with information about their function, the proportion in which they are included in the different pharmaceutical dosage forms and the usual routes of administration.
We identified 18 excipients considered of concern due to their potential to cause harm to the health of specific animal populations: bentonite, benzalkonium chloride, benzoic acid, benzyl alcohol, ethanol, lactose, mannitol, mineral oil, monosodium glutamate, polyethylene glycol, polysorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium lauryl sulfate, sulfites, polyoxyethylene castor oil derivatives, and xylitol. Among the 135 manuscripts listed, only 24 referred to studies in which the substances were correctly evaluated as excipients.
Based on the information presented in this review, the authors hope to draw the attention of professionals involved in veterinary pharmacotherapy to the existence of excipients of concern in medicines. This information contributes to rational veterinary pharmacotherapy and supports veterinary pharmacovigilance actions. We hope to shed light on the subject and encourage studies and new manuscripts that address the safety of pharmaceutical excipients to the animal population.
兽医和药剂师熟悉药物中活性药物成分的疗效和安全性方面，但他们很少关注药物中辅料的安全性。虽然辅料通常被认为是安全的，但它们并非化学惰性物质，在某些动物群体中可能会产生不良反应。本综述旨在介绍这些人群中关注的辅料，并强调其对合理兽医药物治疗的相关性。
基于探索性研究，对关于药物辅料引起动物不良反应的文献进行了全面综述。还提供了这些辅料的正确使用条件和安全性概述，包括其功能、在不同药物剂型中的含量以及常用给药途径的信息。
我们确定了 18 种被认为对特定动物群体健康有潜在危害的辅料：膨润土、苯扎氯铵、苯甲酸、苯甲醇、乙醇、乳糖、甘露醇、矿物油、谷氨酸单钠、聚乙二醇、聚山梨酯、丙二醇、苯甲酸钠、羧甲基纤维素钠、月桂基硫酸钠、亚硫酸盐、聚氧乙烯蓖麻油衍生物和木糖醇。在所列出的 135 篇手稿中，只有 24 篇涉及对这些物质作为辅料进行正确评估的研究。
基于本综述中提供的信息，作者希望引起参与兽医药物治疗的专业人员对药物中关注的辅料的存在的关注。这些信息有助于合理的兽医药物治疗，并支持兽医药物警戒行动。我们希望能阐明这个问题，并鼓励进行研究和新的手稿，以解决药物辅料对动物群体的安全性问题。
