Butoconazole Nitrate

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Cat Number

API64872771

CAS Number

64872-77-1

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Product Detail Description Advanced Innovations Customer Q&A

CAS Number

64872-77-1

EINECS

613-721-6

Storage

2-8℃

Molecular Formula

C19H18Cl3N3O3S

Molecular Weight

474.8

Smiles

C1=CC(=C(C(=C1)Cl)SC(CCC2=CC=C(C=C2)Cl)CN3C=CN=C3)Cl.[N+](=O)(O)[O-]

Appearance

White to off-white solid

Melting Point

159℃

General Description

Butoconazole Nitrate is an imidazole antifungal agent with a thioether side chain, developed specifically for the treatment of vulvovaginal candidiasis. Its chemical structure incorporates a thioether linkage that confers enhanced lipophilicity and improved vaginal tissue penetration. The nitrate salt is stable and provides consistent potency in topical vaginal formulations.

Mechanism of Action

Butoconazole Nitrate inhibits the fungal cytochrome P450 enzyme lanosterol 14-alpha-demethylase (CYP51), blocking the conversion of lanosterol to ergosterol, the essential sterol of the fungal cell membrane. This leads to accumulation of toxic sterol intermediates and disruption of the fungal cell membrane, resulting in fungicidal activity against Candida species including Candida albicans and non-albicans species.

Application

Butoconazole Nitrate is indicated for the local treatment of uncomplicated vulvovaginal candidiasis caused by Candida species.

Mucoadhesive vaginal sponges loaded with butoconazole nitrate (BN) were developed to treat vulvovaginal candidiasis. Sponges were prepared by lyophilization using chitosan, gelatin, HPMC, or carbopol 934, with calcium chloride as a crosslinker and Tween 80 or Labrasol/Transcutol as solubilizers. Chitosan-based sponges showed favorable mechanical properties, high swelling indices, strong mucoadhesion with detachment force up to 88.2 N, and prolonged residence time on cow vaginal mucosa. In vitro drug release followed Higuchi kinetics with Fickian diffusion. The chitosan:HPMC (1:1) sponge with 1.5% Tween 80 (S43) achieved the highest dissolution efficiency (83.5%), drug loading (95%), and antifungal activity against Candida albicans, with a minimum inhibitory concentration of 4.45 μg/mL. FT-IR and DSC confirmed drug-polymer compatibility. Selected sponges remained stable for three months. This mucoadhesive system provides prolonged vaginal retention and improved efficacy over conventional creams.

References

Shaker D S, et al. Butoconazole nitrate vaginal sponge: Drug release and antifungal efficacy. Journal of Drug Delivery Science and Technology, 2018, 48: 274-287.

What is the recommended storage condition for Butoconazole Nitrate?

It should be stored at 2-8°C in a well-sealed container, protected from moisture and direct light, to maintain its chemical integrity throughout the shelf life.

Can we obtain batch-specific analytical data for Butoconazole Nitrate?

Batch-specific COA documents are standard with every shipment. Additional analytical reports, including HPLC chromatograms or spectral data, may be provided upon request.

What quantities of Butoconazole Nitrate are available for order?

We accommodate orders of varying scale, from small research quantities through bulk commercial supply. Contact our sales team to discuss pack sizes and volume pricing.

Is Butoconazole Nitrate compatible with standard pharmaceutical formulation processes?

Pharmaceutical-grade material suitable for standard formulation processes is available. Technical data sheets and compatibility information can be provided upon request.

Is Butoconazole Nitrate suitable for use in regulated pharmaceutical processes?

Yes, it is manufactured under quality standards consistent with regulated pharmaceutical applications, including in-process controls and release testing aligned with industry requirements.