Comparison of solubility profiles for pioneer and generic monensin premixes in biorelevant simulated intestinal fluid based on shake flask extractions

IF 1.5 4区 农林科学 Q3 PHARMACOLOGY & PHARMACY
Beverly J. Krabel, Laura B. Foust, Gary B. Fuller, Robert P. Hunter
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引用次数: 0

Abstract

In the United States, a generic Type A medicated article product can gain the FDA approval by demonstrating bioequivalence (BE) to the pioneer product by successfully conducting a blood level, pharmacodynamic, or clinical BE study. A biowaiver can be granted based on several criteria, assuming the dissolution of the test and reference products represents the only factor influencing the relative bioavailability of both products. Monensin is practically insoluble in H2O per the USP definition. Previously published data from a comparison study of monensin dissolution profiles from the pioneer product and four generic products using biorelevant media showed that generic monensin products demonstrated different dissolution profiles to the pioneer product in these USP biorelevant rumen media. This follow-up study compared the solubility profiles in simulated intestinal fluid (cFaSSIF, pH 7.5) for the pioneer product and four generic products. The generic monensin products demonstrated different in vitro dissolution profiles to the pioneer product in biorelevant media. The differences demonstrated in solubility and dissolution profiles are of concern regarding the potential efficacy of generic monensin in cattle. There are also additional concerns for the potential development of Eimeria resistance in cattle receiving a sub-therapeutic dose of monensin from a less soluble generic product.

基于摇瓶提取法,比较先锋和通用莫能菌素预混剂在生物相关模拟肠液中的溶解度曲线。
在美国,非专利 A 类药用物品产品可通过成功进行血药浓度、药效学或临床生物等效性研究,证明与先驱产品具有生物等效性(BE),从而获得 FDA 批准。如果试验产品和参比产品的溶解度是影响两种产品相对生物利用度的唯一因素,则可根据若干标准批准生物豁免。根据美国药典的定义,莫能菌素几乎不溶于 H2 O。之前公布的使用生物相关介质对先驱产品和四种非专利产品的莫能菌素溶解度曲线进行比较研究的数据显示,在这些 USP 生物相关瘤胃介质中,非专利莫能菌素产品的溶解度曲线与先驱产品不同。这项后续研究比较了先驱产品和四种非专利产品在模拟肠液(cFaSSIF,pH 7.5)中的溶解度曲线。在生物相关介质中,莫能菌素非专利产品的体外溶解度曲线与先驱产品不同。溶解度和溶解曲线的差异令人担忧仿制药莫能菌素对牛的潜在疗效。此外,人们还担心,如果牛只从溶解度较低的仿制产品中摄入低于治疗剂量的莫能菌素,可能会产生艾美耳病抗药性。
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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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