Analysis of US Marketed Artemisinin Supplements for Use in Dogs.

IF 1.5 4区 农林科学 Q3 PHARMACOLOGY & PHARMACY Journal of veterinary pharmacology and therapeutics Pub Date : 2024-08-24 DOI:10.1111/jvp.13480
Alyssa R Berman, Adam J Birkenheuer, Emily L Sorah, Mark G Papich
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Abstract

Oral artemisinin has antiparasitic activity and may help improve treatment success rates in dogs infected with Babesia gibsoni. However, these artemisinin products are unapproved and unregulated botanical supplements. They have not been evaluated for safety and efficacy or for strength, purity, or quality compared with a reference standard. Before considering these products for a clinical study, we evaluated the strength of four suppliers of artemisinin capsules using an high-performance liquid chromatography method validated in our laboratory. We found that the four artemisinin-labeled products that were tested had high within product and between product variability in capsule strength compared with the stated capsule strength on the product label. No products met the acceptance criteria of the United States Pharmacopeia and International Council for Harmonisation (ICH) as well as the criteria adapted by the authors. One product had no detectable artemisinin, and the other three products were much higher than the stated label strength. The results of this study reinforce the importance of testing unapproved and unregulated supplements before recommending a supplement for clinical use in dogs.

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美国市场上供犬使用的青蒿素补充剂分析。
口服青蒿素具有抗寄生虫活性,可能有助于提高感染吉布森巴贝西亚原虫的狗的治疗成功率。不过,这些青蒿素产品是未经批准和监管的植物补充剂。与参考标准相比,它们的安全性和有效性或强度、纯度或质量均未经评估。在考虑将这些产品用于临床研究之前,我们使用实验室验证的高效液相色谱法对四家青蒿素胶囊供应商的青蒿素强度进行了评估。我们发现,与产品标签上标明的胶囊强度相比,接受测试的四种贴有青蒿素标签的产品在产品内部和产品之间的胶囊强度差异很大。没有一种产品符合美国药典和国际协调理事会(ICH)的验收标准以及作者调整的标准。其中一种产品检测不到青蒿素,另外三种产品的青蒿素含量远远高于标签上标明的含量。这项研究的结果强化了在推荐一种补充剂用于狗的临床治疗之前对未经批准和未受管制的补充剂进行检测的重要性。
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来源期刊
CiteScore
3.10
自引率
15.40%
发文量
69
审稿时长
8-16 weeks
期刊介绍: The Journal of Veterinary Pharmacology and Therapeutics (JVPT) is an international journal devoted to the publication of scientific papers in the basic and clinical aspects of veterinary pharmacology and toxicology, whether the study is in vitro, in vivo, ex vivo or in silico. The Journal is a forum for recent scientific information and developments in the discipline of veterinary pharmacology, including toxicology and therapeutics. Studies that are entirely in vitro will not be considered within the scope of JVPT unless the study has direct relevance to the use of the drug (including toxicants and feed additives) in veterinary species, or that it can be clearly demonstrated that a similar outcome would be expected in vivo. These studies should consider approved or widely used veterinary drugs and/or drugs with broad applicability to veterinary species.
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Comparative Pharmacokinetics of Intravenous and Subcutaneous Omeprazole in Sheep and Goats. The Pharmacokinetics of Subcutaneous Eprinomectin in Plasma and Milk in Dry Dairy Cattle. Response to Correspondence on 'Analysis of US Marketed Artemisinin Supplements for Use in Dogs'. Correspondence on Analysis of US Marketed Artemisinin Supplements for Use in Dogs. Detection and Analysis of Florfenicol Residues and Metabolites in Nile Tilapia (Oreochromis niloticus) Tissues Post-Oral Administration in Tropical Waters.
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