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更新于：2024-12-27
Amorolfine Hydrochloride
盐酸阿莫罗芬
更新于：2024-12-27
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1991-12-18), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C21H36ClNO |
InChIKeyXZKWIPVTHGWDCF-KUZYQSSXSA-N |
CAS号78613-38-4 |
关联
16
项与 盐酸阿莫罗芬 相关的临床试验NCT06689852
MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS
ChiCTR2300074178
Q-switched Nd:YAG laser versus Amorolfine Hydrochloride Cream in treatment of Distal lateral subungual onychomycosis in older adults
NCT05482763
Pilot Study on the Evaluation of the Efficacy, Tolerability and Safety of Topical and Oral Antifungals in the Treatment of Onychomycosis and Creation of a Library of Dermatological Clinical Isolates
100 项与 盐酸阿莫罗芬 相关的临床结果
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100 项与 盐酸阿莫罗芬 相关的转化医学
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100 项与 盐酸阿莫罗芬 相关的专利（医药）
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287
项与 盐酸阿莫罗芬 相关的文献（医药）2024-12-01Annales Pharmaceutiques Francaises
Amorolfine hydrochloride loaded solid lipid nanoparticles: Preparation, characterization and ex vivo nail permeation study to treat onychomycosis
Article
作者: Ahmed, Tasleem ; Mahato, Arun Kumar ; Shanthi, Nithya
Onychomycosis is a disease of the nail plate caused by fungi, leading to the progressive defacing of the nail. The infection requires a longer period of treatment orally and topically. The treatment with the topical route is difficult due to the low availability of drugs across the infected nail. This failure in topical treatment is the drawback of the conventional drug delivery system (DDS), particularly drug penetration issues across the nail plate. The solid lipid nanoparticle (SLN) approach was used to overcome such issues. The drug amorolfine hydrochloride (AOF) was incorporated into SLN by using the micro-emulsion cold dilution method. Monostrearin and stearic acid were used as solid lipids in the formulation of drug-loaded SLNs. The nanoparticle formulation was optimized by varying the type of solid lipids and bile salts. Sodium taurocholate (STC) and sodium tauroglycholate (STG) are the bile salts used as biosurfactants in the formulation. The SLNs prepared with stearic acid and STG demonstrated higher drug encapsulation efficiency (71.73%) and drug loading efficiency (13.03%) than monostearin. Bile salts have affected the particle size range and STG was found to produce smaller size particles with stearic acid (406nm) than STC. Process parameter homogenization speed was also optimized and 403 relative centrifugal force (RCF) was optimal to produce smaller-size particles (406nm). The drug permeation through the nail plate and anti-fungal studies were also performed for AOF-SLNs loaded cream and marketed cream (Amfocin). The SLNs have improved the permeation (1.63-fold) and anti-fungal activity (2.50-fold) of AOF. Transmission electron microscopy (TEM) images revealed a spherical shape of SLNs with no aggregation. The physical stability was performed and SLNs have higher stability at refrigeration storage. The SLNs were incorporated in cream for the final application for onychomycosis. The analytical method of high-performance liquid chromatography (HPLC) was used for the quantification of AOF in the formulations.
2024-12-01FUNDAMENTAL & CLINICAL PHARMACOLOGY
Nociceptive TRP channels function as molecular target for several antifungal drugs
Article
作者: Takahashi, Kenji ; Ohta, Toshio ; Okabe, Shota ; Hashimoto, Miho
Abstract:
Background/objectives:
Topically applied antifungal agents can induce adverse effects, such as pain and irritation. The transient receptor potential (TRP) channels—TRPA1 and TRPV1—mainly expressed in sensory neurons, act as sensors for detecting irritants. This study aims to evaluate the involvement of nociceptive channels in topical antifungal‐induced pain and irritation. We tested nine topical antifungals belonging five classes: isoconazole, econazole, miconazole, clotrimazole, and ketoconazole as imidazoles; liranaftate as a thiocarbamate; terbinafine as an allylamine; amorolfine as a morpholine; and butenafine as a benzylamine.
Methods:
Intracellular calcium concentrations ([Ca2+]i) and membrane currents in response to antifungals were measured to estimate channel activity using heterologously expressing cells and isolated mouse sensory neurons.
Results:
In mouse TRPA1‐expressing cells, all the tested drugs induced an increase in [Ca2+]i, which was abrogated or reduced by a TRPA1 blocker. Although many drugs evoked the TRPA1‐nonspecific [Ca2+]i response at high concentrations, responses to clotrimazole, ketoconazole, and liranaftate were TRPA1 specific and elicited current responses in TRPA1‐expressing cells. In mouse TRPV1‐expressing cells, clotrimazole and ketoconazole elicited [Ca2+]i and current responses. In mouse sensory neurons, liranaftate‐induced increase in [Ca2+]i was abrogated by a TRPA1 blocker and Trpa1 deletion. Responses to ketoconazole were inhibited by TRPA1 and TRPV1 blockers and by the genetic deletion of either channel.
Conclusion:
These results suggest that topical antifungal‐induced pain and irritation are attributable to the activation of nociceptive TRPA1 and/or TRPV1 channel/s. Consequently, caution should be exercised in the use of topical antifungals with symptoms of pain.
2024-09-01MYCOSES
Efficacy of Amorolfine in Onychomycosis Treatment: A Mixed‐Effects Models and Multivariate Logistic Regression Analysis
Article
作者: Jiang, Guan ; Ding, Mingming ; Du, Chichi ; Zhang, Lin
ABSTRACT:
Background:
Onychomycosis (OM) is a common nail infection treated with amorolfine hydrochloride nail lacquer in China. Monitoring drug concentrations and using dermoscopy to evaluate treatment efficacy may provide new insights.
Objective:
The study aims to analyse amorolfine concentrations in nails with mild to moderate OM, assess treatment outcomes using dermoscopy and explore factors influencing drug concentrations and efficacy.
Methods:
Patients with mild to moderate OM confirmed by fungal microscopy were enrolled. Amorolfine nail lacquer was applied twice weekly for 36 weeks. Monthly nail samples measured amorolfine concentrations using liquid chromatography. Dermoscopy was performed before and after treatment to evaluate responses. Mixed‐effects models and logistic regression analysed factors affecting drug concentrations and outcomes.
Results:
Ninety‐seven nails were included. Amorolfine concentrations increased over time, with higher levels in females, fingernails, 2nd–5th digits and superficial white OM (p < 0.05). Age was a risk factor, while drug concentration and OM type were protective for clinical efficacy (p < 0.05). Peak concentration correlated with clinical (r = 0.487, p = 0.000) and mycological (r = 0.433, p = 0.000) responses. Dermoscopic features improved significantly in successful cases (p < 0.05).
Limitations:
In the assessment of fungal efficacy, only fungal microscopy was used, and fungal cultures were not performed. The study was limited by a small sample size and the lack of a longer follow‐up to assess relapse.
Conclusion:
Amorolfine concentrations vary with patient and nail characteristics, influencing efficacy. Dermoscopy is valuable for monitoring OM treatment.
100 项与 盐酸阿莫罗芬 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 传染性皮肤病 | 中国 | 2000-04-10 | |
| 皮肤念珠菌病 | 日本 | 1993-10-01 | |
| 银屑病 | 日本 | 1993-10-01 | |
| 足癣 | 日本 | 1993-10-01 | |
| 白癜风 | 日本 | 1993-10-01 | |
| 真菌病 | 日本 | 1991-12-18 |
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临床结果
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临床4期 | 50 | (Loceryl NL+Cosmetic Varnish) | 壓選願鏇構觸餘餘構遞(齋糧憲構鹹築繭夢獵壓) = 鹽鑰壓壓鏇範繭襯構範 夢選網憲鏇衊齋鑰鏇膚 (憲糧廠餘夢窪鹽顧廠築, 鹽遞構齋廠鑰選選願膚 ~ 艱鏇繭獵鬱築觸積醖製) 更多 | - | 2018-10-09 | ||
(Loceryl NL 12 Weeks) | 壓選願鏇構觸餘餘構遞(齋糧憲構鹹築繭夢獵壓) = 範鹽膚窪範鬱蓋築選艱 夢選網憲鏇衊齋鑰鏇膚 (憲糧廠餘夢窪鹽顧廠築, 製簾糧網醖築襯淵觸鏇 ~ 積築鬱憲醖顧蓋窪願觸) 更多 | ||||||
临床4期 | 20 | (Loceryl NL) | 淵齋憲構簾蓋構築選顧(觸艱遞窪鬱範積蓋襯鏇) = 醖壓夢襯餘遞願網蓋鏇 餘鬱窪選蓋鏇衊構築鬱 (鹽獵夢夢簾鹽簾遞顧齋, 衊鹹積衊膚壓齋膚艱顧 ~ 醖窪窪製獵淵蓋願網齋) 更多 | - | 2018-10-03 | ||
(Ciclopirox NL) | 淵齋憲構簾蓋構築選顧(觸艱遞窪鬱範積蓋襯鏇) = 醖簾鏇窪築獵觸鏇窪鑰 餘鬱窪選蓋鏇衊構築鬱 (鹽獵夢夢簾鹽簾遞顧齋, 構糧廠蓋壓餘選齋簾壓 ~ 襯糧壓鏇憲醖製願鑰鹽) 更多 |
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