We supply Terbinafine hcl API

We're proud to offer high- quality Terbinafine HCl API for use in pharmaceutical product processes. Our Terbinafine is produced using advanced manufacturing processes and undergoes rigorous quality control testing to insure chastity, thickness, and safety. It's a largely effective antifungal drug generally used to treat a range of skin and nail infections. Our API is available in large amounts and can be customized to meet your specific product requirements. Trust us to give you with the dependable and harmonious force of Terbinafine HCl API you need for your pharmaceutical products.

What is Terbinafine hcl

Terbinafine hydrochloride powder is a broad- diapason antifungal medicine used in the dermatology of acrylamide. Developed by Swiss pharmaceutical company Novartis in the 1980s, it was first launched in the UK in 1991. In 1996, it was approved by the US FDA as an OTC medicine and was launched in the United States the same time. presently, it's vended in over 90 countries worldwide. It can specifically disrupt the late stage biodegradation of fungal sterols, widely inhibit the exertion of fungal squalene epoxidase, and hamper the squalene epoxidation response in the process of fungal cell chemical membrane conformation, thereby achieving the effect of killing or inhibiting fungi. Suitable for treating skin candidiasis, similar as tinea manus, tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, it's also the stylish drug for treating argentine nails. In 2000, it was included in the first batch of OTC registers published by the country. This product belongs to the antifungal class and has a strong effect on superficial fungal infections. Topical use can cure the vast maturity of skin fungal conditions.

Basic Information

Product Name: Terbinafine hydrochloride

CAS:78628-80-5

MF:C21H26ClN

MW:327.89

EINECS:616-640-4

MDL No.:MFCD00145430

Structural formula:

Purity: 99%+

Origin: China

Application: Antifungal

Delivery Time: stock

Melting point: 204-208 ° C

Solubility: soluble in methanol: 50mg/mL

Technical Specification:

Package: 1kg; 25kg

Storage conditions: keep tightly closed, store in a cool dry place.

Pharmacokinetics

According to literature reports, a single oral dose of 250mg of terbinafine hydrochloride resulted in a peak plasma concentration of 0.97 within 2 hours after administration μ The absorption half-life of this product is 0.8 hours, and the dispersion half-life is 4.6 hours. Its bioavailability is slightly affected by food consumption, but dose adjustment is not required. The binding rate between drugs and plasma proteins is 99%, and they can quickly diffuse through the dermis and concentrate in the lipophilic stratum corneum. Terbinafine  can also be dispersed in the skin, thus achieving relatively high concentrations in hair follicles, hair, and multi-layered skin. In the last few weeks of treatment, it can enter the deck. The metabolites of this product after biotransformation have no antifungal activity and are mainly excreted from the urine. Its half-life for elimination is 17 hours, and it has no accumulation effect in the body. Its steady-state blood drug concentration is not affected by age. However, its elimination rate  in patients with liver and kidney dysfunction can be reduced, leading to a decrease in blood drug concentration.

Indications

1. Skin, hair, and nail infections caused by Trichophyton (Trichophyton albicans, Trichophyton trichophyton, Trichophyton verrucosum, Trichophyton truncatum, and Trichophyton purpurea), Microsporium canis, and Trichophyton flocculent.

2. Various ringworm diseases (such as tinea corporis, tinea cruris, tinea manus and pedis, and tinea scalp) as well as skin yeast infections caused by Candida albicans.

3. Onychomycosis caused by fungal infection.

Synthetic method

1. Synthesis of crude Terbinafine hydrochloride powder: Add 12.5ml of purified water and potassium carbonate (4.06g, 29.2mmol) to a 100ml three necked reaction flask, stir and dissolve, then add N-methylnaphthylamine (5.01g, 29.2mmol), then add 1-chloro-6,6-dimethyl-2-heptane-4-yne (4.57g, 29.2mmol), heat up to 80 ℃ for reaction, after 4 hours, cool to room temperature, add 25ml of ethyl acetate for extraction, separate the ethyl acetate phase, and cool to 0-10 ℃. Add 6N hydrochloric acid aqueous solution dropwise, adjust pH to 1, stir for 1-2 hours, filter, and vacuum the filter cake at 70 ℃. Dry for 4 hours to obtain crude terbinafine hcl (8.51g, yield: 89%);

2. Purification of crude terbinafine hcl powder: Add crude terbinafine hcl (8.51g, 26.8mmol) and 106ml of purified water to a 250ml single necked bottle, heat and reflux to clear solution, cool naturally to room temperature, then cool to 0-10 ℃ in an ice bath, stir for 1 hour, filter, and vacuum dry the filter cake at 70 ℃ for 3 hours to obtain finished terbinafine hydrochloride (7.66g, purity 99.988%, yield 90%).

What is the application of Terbinafine hydrochloride

Terbinafine hydrochloride is an acrylamide drug with broad-spectrum antifungal activity, which has significant therapeutic effects on fungal induced athlete's foot, onychomycosis, tinea corporis, tinea cruris, and tinea versicolor. It can also be used for bronchial asthma, asthmatic bronchitis, and emphysema.

Contact information

 Xi 'an Yihui Company as a professional manufacturer of Terbinafine hydrochloride powder, with high-quality products, high level of research and development capabilities, advanced production equipment and technology, perfect after-sales service and other advantages, is the customer choice of the ideal partner.

if you need it, pls feel free to contact us any time. we will reply you ASAP.

Our contact information:

E-mail: sales@yihuipharm.com
Tel: 0086-29-89695240
WeChat or WhatsApp: 0086-17792415937

Reference:

Wang Aiping, Li Ruoyu, Zeng Fanqin, etc A randomized double-blind controlled multicenter clinical trial of 1% terbinafine hydrochloride ointment for the treatment of superficial fungal disease. WanFang, 2001

Shuai Wuping, Shen Tu Jianzhong Pharmacokinetics of domestic and imported terbinafine hydrochloride tablets for oral administration. Chinese Journal of Hospital Pharmacy, 2005

Ge Jing, Ye Kefan Clinical observation of 57 cases of recurrent vulvovaginal candidiasis treated with combination of terbinafine hydrochloride vaginal vesicular vine tablets and lactobacillus live bacteria. CNKI; WanFang, 2012

Bian Meilu, Chen Qingyun, Zhang Youzhong, etc Treatment of 71 cases of vulvovaginal candidiasis with terbinafine hydrochloride vaginal effervescent tablets. Chinese Journal of New Drugs, 2005

Chen Huijuan, Zhao Xiaoping, Lv Lianfeng 49 cases of recurrent candidal vaginitis treated with combination of terbinafine hydrochloride vaginal effervescent tablets and traditional Chinese medicine external washing. Liaoning Journal of Traditional Chinese Medicine, 2007