更新于：2024-05-24
Fexofenadine Hydrochloride
盐酸非索非那定
更新于：2024-05-24
概要
基本信息
简介非索非那定于1996年3月获得FDA批准，是一种令人费解的小分子药物，可作为H1受体拮抗剂。该药物阻碍组胺在H1受体的作用，减少呼吸超敏反应，荨麻疹，皮炎，瘙痒和其他皮肤病。非索非那定主要用于这些疾病，有助于缓解其症状。赛诺菲是非索非那定的神秘鼻祖组织，已在临床上得到广泛应用。尽管其广泛使用，但这种药物的具体作用机制尚不清楚。然而，非索非那定是治疗过敏和相关疾病的重要武器，尽管它可能导致嗜睡和口干以及其他副作用。非索非那定副作用的可变性和不精确的作用方式突出了进一步研究以充分理解药物作用机制的必要性。 |
药物类型 小分子化药 |
别名 Allegra 5%、Fexofenadine hydrochloride (JP17/USP)、Fexofenading Hydrochloride + [21] |
作用机制 H1 receptor拮抗剂(组胺H1受体拮抗剂) |
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C32H40ClNO4 |
InChIKeyRRJFVPUCXDGFJB-UHFFFAOYSA-N |
CAS号153439-40-8 |
关联
58
项与 盐酸非索非那定 相关的临床试验A Bioequivalence study of a randomized, open-label, single dose, full replicate crossover design with four-period, two-treatment, and two-sequence of Fexofenadine 180 mg tablets relative to Telfast 180 mg tablets in healthy Thai volunteers under fasting condition.
A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)
Open-Label, Single-Dose, Randomized, 6-Treatment, 6-Sequence, 6-Period Crossover Relative Bioavailability Study Comparing Fexofenadine HCl New Formulation Tablets (Test Drug) With or Without Water to Fexofenadine HCl Coated Tablets (Reference Drug) With Water in Healthy Male and Female Subjects Under Fasting Conditions
100 项与 盐酸非索非那定 相关的临床结果
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100 项与 盐酸非索非那定 相关的转化医学
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100 项与 盐酸非索非那定 相关的专利（医药）
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162
项与 盐酸非索非那定 相关的文献（医药）2024-02-01Luminescence : the journal of biological and chemical luminescence
Eco‐friendly synchronous fluorescence spectrofluorimetric method for simultaneous determination of montelukast sodium and fexofenadine hydrochloride in their antiallergic rhinitis fixed‐dose combination tablets
Article
作者: Abdel Hamid, Mohamed A ; Michael, Mary A ; Mabrouk, Mokhtar M
Abstract:
An innovative, simple, accurate, sensitive, and eco‐friendly synchronous fluorescence spectrofluorimetric method has been developed for the simultaneous analysis of montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The method relies on measuring the relative synchronous fluorescence intensity of both drugs using Δλ of 60 nm in methanol at 405 nm for MON and 288 nm for FEX. The experimental parameters influencing the developed method were investigated and optimized. The method was linear over the ranges 0.1–2.0 and 2.0–20.0 μg/ml for MON and FEX, respectively. The limits of detection were 0.018 and 0.441 μg/ml, and the limits of quantitation were 0.055 and 1.336 μg/ml for MON and FEX, respectively. The developed method was applied successfully for the determination of the two drugs in their newly released fixed‐dose combination prescribed for the treatment of allergic rhinitis. The mean per cent recoveries were found to be 100.680 ± 0.890 and 100.110 ± 0.940 for MON and FEX, respectively. Furthermore, the method was found to be eco‐friendly green as was evaluated according to the Green Analytical Procedure Index tool guidelines and analytical eco‐scale.
2024-01-23Chemical & pharmaceutical bulletin
Development of Ethylcellulose Microparticles for Taste Masking of Fexofenadine
Article
作者: Shibazaki, Ikki ; Shimana, Aoi ; Yamazaki, Kurumi ; Morii, Machi ; Obata, Yasuko ; Ikeuchi-Takahashi, Yuri
For taste masking of fexofenadine hydrochloride (FXD), ethylcellulose (EC) microparticles with FXD were developed. The amounts of EC, Tween 80, and polyvinyl alcohol (PVA) in the composition had little effect on initial drug release properties. Based on the results of the drug recovery and the drug release properties, FXD(EC200) was the optimal FXD microparticle formulation. From the results of Fourier transform infrared spectroscopy spectra and X-ray diffraction patterns of FXD(EC200), FXD amorphization in the microparticles and interaction between FXD and other components were suggested, and the formation of a solid dispersion of FXD was suggested. Because the possibility of the complex of PVA and FXD on the particle surface was suggested, sodium lauryl sulfate (SLS) was added to the composition. The initial drug release from FXD microparticles with SLS was further suppressed compared with FXD(EC200). From these results, FXD microparticles with SLS can be prepared as a controlled-release formulation and are expected to be useful for masking the bitter tasting particulates.
2023-12-01Clinical pharmacology in drug development
Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride Oral Suspension
Article
作者: De Fer, Beatrice Bois ; Lucio, Luiz ; Lheritier-Barrand, Michele ; Rauch, Clemence
Abstract:
Fexofenadine hydrochloride (HCl) is a second‐generation, nonsedating, histamine H1‐receptor antagonist used to manage seasonal allergic rhinitis and chronic idiopathic urticaria. A new oral pediatric suspension of fexofenadine HCl has been developed, with the preservative potassium sorbate replacing parabens. The objective of this phase 1 single‐center, open‐label, randomized, 2‐treatment, full‐replicated, 4‐period, 2‐sequence crossover study in healthy adult volunteers was to assess the bioequivalence of 30 mg of the new oral suspension of fexofenadine HCl (test) versus 30 mg of the marketed pediatric oral suspension of fexofenadine HCl (reference). The replicate design was based on the high intra‐individual variability of fexofenadine (>30% on Cmax). The study comprised 68 randomized and treated volunteers. Plasma concentrations of fexofenadine were similar following the administration of a single dose of each formulation. Cmax, AUClast, AUC, median tmax, and mean t1/2z were similar between administrations of the same fexofenadine formulation and between formulations. A high intra‐individual variability was confirmed with both formulations. Bioequivalence of the test and reference fexofenadine HCl formulations was demonstrated as the 90% confidence intervals of the geometric least squares mean ratio for Cmax, AUClast, and AUC of fexofenadine were all within the bioequivalence range of 0.80‐1.25. There were no serious adverse events (AEs) or study discontinuations due to treatment‐emergent AEs with either fexofenadine HCl formulation. The new paraben‐free fexofenadine HCl 30‐mg oral suspension and marketed fexofenadine HCl 30‐mg pediatric oral suspension are bioequivalent under fasting conditions, with no safety concerns and a safety profile consistent with the known profile of fexofenadine.
100 项与 盐酸非索非那定 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 过敏性鼻炎 | 韩国 | 1998-05-04 | |
| 荨麻疹 | 澳大利亚 | 1997-01-10 | |
| 慢性荨麻疹 | 英国 | - | 1996-03-11 |
| 特应性皮炎 | 英国 | - | 1996-03-11 |
| 湿疹 | 英国 | - | 1996-03-11 |
| 瘙痒 | 英国 | - | 1996-03-11 |
| 季节性过敏性鼻炎 | 英国 | - | 1996-03-11 |
未上市
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临床结果
临床结果
适应症
分期
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临床3期 | 95 | (Arm A (Active-active)) | 艱鹽繭襯餘窪艱範餘鬱(積齋繭夢廠艱廠鏇蓋鑰) = 範壓顧獵構顧艱製齋衊 壓窪餘膚壓襯鬱願顧膚 (蓋蓋觸廠築鑰艱遞選製, 簾顧膚糧壓積築鑰製構 ~ 襯夢餘淵獵糧糧築築選) 更多 | - | 2024-05-16 | ||
Placebo (Arm B (Placebo-active)) | 艱鹽繭襯餘窪艱範餘鬱(積齋繭夢廠艱廠鏇蓋鑰) = 蓋襯衊鹽襯製選鬱選遞 壓窪餘膚壓襯鬱願顧膚 (蓋蓋觸廠築鑰艱遞選製, 襯獵淵獵繭憲鹹餘艱製 ~ 願鏇範網夢鏇廠網鑰膚) 更多 | ||||||
N/A | 145 | 範襯膚範獵鹽範範簾醖(艱網膚鹹網餘製積築製) = 鑰範蓋選淵積築範網鏇 選夢繭觸築窪選鹹鬱繭 (遞衊鏇網顧選壓製鹹鬱 ) 更多 | - | 2012-05-20 | |||
範襯膚範獵鹽範範簾醖(艱網膚鹹網餘製積築製) = 膚壓衊齋夢簾選鹽鹽襯 選夢繭觸築窪選鹹鬱繭 (遞衊鏇網顧選壓製鹹鬱 ) 更多 | |||||||
N/A | - | Fexofenadine HCl 6 mg/mL Suspension | 夢網簾鏇繭襯願積膚積(觸糧構顧醖獵範淵廠餘) = Ten treatment-emergent adverse events (TEAEs) occurred in seven subjects. No serious, one moderate intensity (pyrexia) and nine mild intensity TEAEs were reported. All TEAEs resolved without sequelae. 齋蓋壓壓構餘淵壓積願 (選鹹遞夢衊餘選憲網選 ) 更多 | 积极 | 2007-01-01 |
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