枸橼酸托法替尼对 Wistar 大鼠的急性口服毒性:对新型口腔溶解制剂的影响

Q2 Pharmacology, Toxicology and Pharmaceutics
Meghana Raykar, M. Velraj
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引用次数: 0

摘要

目的:枸橼酸托法替尼是治疗各种疾病的常用药物。口腔溶解制剂为患者的依从性提供了潜在的益处。本研究旨在评估这些制剂中枸橼酸托法替尼的急性口服毒性,以确保其安全性和有效性:本研究旨在评估枸橼酸托法替尼口腔溶解制剂的急性口服毒性,并评估其对食物和水消耗量、血液学和生化指标以及器官组织病理学的影响。雌雄 Wistar 大鼠分为四组。对照组饮用蒸馏水,治疗组分别口服 5 毫克/千克、100 毫克/千克和 300 毫克/千克的枸橼酸托法替尼。观察14天,评估动物的一般外观、行为、食物和水的消耗量以及死亡率。对重要器官进行了血液学和生化分析以及组织病理学检查:在急性毒性研究中,枸橼酸托法替尼最高剂量为 300 毫克/千克时,Wistar 大鼠没有表现出毒性。与对照组相比,食物/水摄入量以及主要器官的血液学、生物化学和组织病理学参数均保持不变,这表明该化合物不会对全身产生影响,并肯定了其口腔溶解制剂的安全性:结论:枸橼酸托法替尼口腔溶解制剂具有良好的安全性,无急性口腔毒性。正常的消耗量、不变的参数以及无器官异常都支持其安全性。需要进一步调查以评估慢性毒性和长期安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
ACUTE ORAL TOXICITY OF TOFACITINIB CITRATE IN WISTAR RATS: IMPLICATIONS FOR NOVEL MOUTH DISSOLVING FORMULATIONS
Objective: Tofacitinib citrate is a commonly used therapeutic agent for various diseases. Mouth-dissolving formulations provide potential benefits for patient compliance. This study aims to evaluate the acute oral toxicity of tofacitinib citrate in these formulations to ensure their safety and efficacy. Methods: This study aimed to assess the acute oral toxicity of tofacitinib citrate in mouth-dissolving formulations and evaluate its effects on food and water consumption, hematological and biochemical parameters, and organ histopathology. Male and female Wistar rats were divided into four groups. The control group received distilled water, while the treated groups were orally administered tofacitinib citrate at 5 mg/kg, 100 mg/kg, and 300 mg/kg. Observations were made over 14 d, assessing general appearance, behavior, food and water consumption, and mortality. Hematological and biochemical analyses and histopathological examinations were conducted on vital organs. Results: In acute toxicity studies, Wistar rats showed no toxicity at up to 300 mg/kg tofacitinib citrate. Compared to controls, food/water intake and hematological, biochemical, and histopathological parameters of major organs remained unchanged, indicating no systemic effects and affirming the compound's safety in mouth-dissolving formulations. Conclusion: Tofacitinib citrate in mouth-dissolving formulations demonstrated a favorable safety profile with no acute oral toxicity. Normal consumption, unchanged parameters, and no organ abnormalities support its safety. Further investigation is required to assess chronic toxicity and long-term safety.
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来源期刊
International Journal of Applied Pharmaceutics
International Journal of Applied Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
CiteScore
1.40
自引率
0.00%
发文量
219
期刊介绍: International Journal of Applied Pharmaceutics (Int J App Pharm) is a peer-reviewed, bimonthly (onward March 2017) open access journal devoted to the excellence and research in the pure pharmaceutics. This Journal publishes original research work that contributes significantly to further the scientific knowledge in conventional dosage forms, formulation development and characterization, controlled and novel drug delivery, biopharmaceutics, pharmacokinetics, molecular drug design, polymer-based drug delivery, nanotechnology, nanocarrier based drug delivery, novel routes and modes of delivery; responsive delivery systems, prodrug design, development and characterization of the targeted drug delivery systems, ligand carrier interactions etc. However, the other areas which are related to the pharmaceutics are also entertained includes physical pharmacy and API (active pharmaceutical ingredients) analysis. The Journal publishes original research work either as a Original Article or as a Short Communication. Review Articles on a current topic in the said fields are also considered for publication in the Journal.
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