更新于：2024-05-19
Terbinafine Hydrochloride
盐酸特比萘芬
更新于：2024-05-19
概要
基本信息
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C21H26ClN |
InChIKeyBWMISRWJRUSYEX-SZKNIZGXSA-N |
CAS号78628-80-5 |
关联
45
项与 盐酸特比萘芬 相关的临床试验A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
盐酸特比萘芬片在中国健康受试者中随机、开放、两制剂、单次给药、两周期交叉、空腹及餐后状态下生物等效性试验
100 项与 盐酸特比萘芬 相关的临床结果
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100 项与 盐酸特比萘芬 相关的转化医学
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100 项与 盐酸特比萘芬 相关的专利（医药）
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216
项与 盐酸特比萘芬 相关的文献（医药）2023-11-01Heliyon
Ternary cyclodextrin systems of terbinafine hydrochloride inclusion complexes: Solventless preparation, solid-state, and in vitro characterization
Article
作者: Kókai, Dávid ; Catenacci, Laura ; Csóka, Ildikó ; Sorrenti, Milena ; Burián, Katalin ; Ambrus, Rita ; Kondoros, Balázs Attila
Cyclodextrins (CD) are used extensively in the pharmaceutical industry to improve the water solubility and bioavailability of drugs. Preparing ternary systems by applying a third component can enhance these beneficial effects. The complexation methods of these ternary systems are the same as those of two-component complexes. These methods are solvent (co-evaporation, co-precipitation, etc.) or solventless "green" techniques (co-grinding, microwave irradiation, etc.). Using solvent-free methods is considered to be an economically and environmentally desirable technology. This study aimed to prepare ternary systems by the co-grinding method and evaluate the effect of a third component by comparing it to products obtained by solvent methods, binary systems, and marketed products. For that, we used terbinafine hydrochloride as a model drug, sulfobutyl-ether-beta-cyclodextrin as a complexation agent and 5 or 15 w/w% of polyvinylpyrrolidone K-90 (PVP) or hydroxypropyl methylcellulose (HPMC) as auxiliary components. Physicochemical evaluation (X-Ray Diffractometry, Differential Scanning Calorimetry, Thermogravimetry) showed that new solid phases were formed, while Scanning Electron Microscopy was performed to study morphological aspects of the products. Fourier transform infrared spectroscopic measurements suggested different intermolecular interactions depending on the type of polymer. In vitro dissolution studies showed beneficial effects of CD and further improvement with the applied polymers. Products showed less cell toxicity with one exception. Both polymers enhanced the physicochemical and in vitro properties, suggesting a greater bioavailability of the model drug. However, the percentage of polymers applied did not appear to be an influencing factor for these properties.
2023-10-20Gels (Basel, Switzerland)
Thermo-Responsive Sol-Gel-Based Nano-Carriers Containing Terbinafine HCl: Formulation, In Vitro and Ex Vivo Characterization, and Antifungal Activity.
Article
作者: Irfan, Ali ; Bajwa, Maryam ; Mehboob, Tooba ; Jardan, Yousef A Bin ; Tabassam, Naila ; Zaman, Muhammad ; Riaz, Tehseen ; Hameed, Huma ; Khan, Mahtab Ahmad ; Shazly, Gamal A
The current research aims to create a sol-gel-based nanocarrier containing terbinafine formulated for transdermal delivery of the drug into the skin. Sol-gel-based nanocarriers were prepared via the cold method using poloxamer-188, poloxamer-407, and distilled water. The prepared formulation was examined for pH, gelation temperature, Fourier transform infrared spectrophotometer (FTIR) analysis, thermal stability analysis, X-ray diffraction (XRD), scanning electron microscopy (SEM), particle size analysis, zeta potential, and anti-microbial activity. The in-vitro drug release study of F1 was found to be 94%, which showed greater drug release as compared to F2 and F3. The pH of the formulation was found to be within the range applicable to the skin. The gelation temperature was detected at 28 °C. The SEM images of formulations have spotted various particles well-segregated from each other. Analysis of formulations showed a mean globule size diameter of 428 nm, zeta potential values of 0.04 mV, refractive index (1.329), and viscosity (5.94 cP). FTIR analysis confirmed various functional groups' presence in the prepared formulation. Thermal analysis has confirmed the stability of the drug within the prepared formulation. The growth of inhibition was found to be 79.2% in 60 min, which revealed that the prepared formulation has shown good permeation from the membrane. Hence, the sol-gel-based nanocarrier formulation of terbinafine was successfully developed and evaluated.
2023-10-02AAPS PharmSciTech
Polymeric Nanocapsules Containing Ozonated Oil and Terbinafine Hydrochloride as a Potential Treatment Against Dermatophytes.
Article
作者: Contri, Renata Vidor ; Marques, Morgana Souza ; da Costa, Bárbara Souza ; Zilles, Júlia Capp ; Dos Santos, Francielli Lima ; Machado, Andressa Urbano ; Fuentefria, Alexandre Meneghello ; Kulkamp Guerreiro, Irene Clemes
Terbinafine hydrochloride is a synthetic allylamine whose mechanism of action consists of inhibiting the enzyme squalene epoxidase that participates in the first stage of ergosterol synthesis, interfering with fungal membrane function. Ozonated oils are used for topical application of ozone, producing reactive oxygen species that cause cellular damage in microorganisms, therefore being an alternative treatment for acute and chronic skin infections. This study aimed to develop and characterize Eudragit® RS100 nanocapsules, obtained by interfacial deposition of preformed polymer method, containing 0.5% terbinafine hydrochloride and 5% ozonated sunflower seed oil as a potential treatment against dermatophytes. The polymeric nanocapsules were characterized regarding particle size, zeta potential, pH, drug content, encapsulation efficiency, and stability. The in vitro drug release, in vitro skin permeation, and in vitro antifungal activity were also evaluated. The particle size was around 150 nm with a narrow size distribution, the zeta potential was around + 6 mV, and the pH was 2.2. The drug content was close to 95% with an encapsulation efficiency of 53%. The nanocapsules were capable to control the drug release and the skin permeation. The in vitro susceptibility test showed greater antifungal activity for the developed nanocapsules, against all dermatophyte strains tested, compared to the drug solution. Therefore, the polymeric nanocapsules suspension containing terbinafine hydrochloride and ozonated oil can be considered a potential high-efficacy candidate for the treatment of dermatophytosis, with a possible reduction in the drug dose and frequency of applications. Studies to evaluate safety and efficacy in vivo still need to be performed.
100 项与 盐酸特比萘芬 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 足癣 | 美国 | 1999-03-09 | |
| 皮肤真菌病 | 中国 | 1997-01-01 | |
| 皮肤念珠菌病 | 日本 | 1993-07-02 | |
| 花斑癣 | 日本 | 1993-07-02 | |
| 头癣 | 美国 | 1992-12-30 | |
| 真菌病 | 英国 | 1990-10-03 | |
| 甲癣 | 英国 | 1990-10-03 | |
| 癣 | 英国 | 1990-10-03 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 红斑 | 临床1期 | 美国 | 2017-10-15 |
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临床3期 | - | 糧膚艱廠繭餘鑰鑰鏇糧(鏇壓鏇構選獵簾顧築淵) = 觸窪鑰觸襯淵齋顧製築 簾鹹艱選範獵衊廠範繭 (鬱遞夢鹹繭餘膚膚鹹淵 ) 更多 | 非优 | 2021-07-01 | |||
vehicle | 糧膚艱廠繭餘鑰鑰鏇糧(鏇壓鏇構選獵簾顧築淵) = 襯淵鹹憲齋積鏇蓋齋積 簾鹹艱選範獵衊廠範繭 (鬱遞夢鹹繭餘膚膚鹹淵 ) 更多 | ||||||
临床3期 | 452 | 襯繭醖鹹淵憲齋壓鹽築(壓醖鹹簾選鏇齋鏇夢壓) = 獵艱艱鏇糧顧糧願糧夢 淵醖簾艱夢憲積廠夢艱 (鏇廠範簾蓋製鹹觸顧夢 ) 更多 | 非劣 | 2020-06-25 | |||
襯繭醖鹹淵憲齋壓鹽築(壓醖鹹簾選鏇齋鏇夢壓) = 齋鹽窪簾夢範膚鹽簾範 淵醖簾艱夢憲積廠夢艱 (鏇廠範簾蓋製鹹觸顧夢 ) 更多 |
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