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Isoconazole | CAS No: 27523-40-6 | GMP-certified suppliers
A medication that provides topical antifungal treatment for dermatophytic infections and vulvovaginal candidiasis with minimal systemic absorption and established clinical use.
Therapeutic categories
Product Snapshot
- Isoconazole is available in multiple topical formulations including creams, solutions, sprays, inserts, suppositories, and irrigants for cutaneous and vaginal administration
- It is primarily indicated for antifungal therapeutic applications
- Isoconazole is approved for use in key regulatory markets
Clinical Overview
The antifungal activity of isoconazole is consistent with azole compounds, which exert their effect by inhibiting the fungal cytochrome P450 enzyme lanosterol 14α-demethylase. This inhibition disrupts the biosynthesis of ergosterol, an essential component of fungal cell membranes, leading to increased membrane permeability and eventual cell death. While detailed pharmacodynamics parameters specific to isoconazole are limited, its mechanism aligns with other imidazole derivatives used topically.
Absorption following topical application is minimal, resulting in low systemic exposure. Metabolic pathways and excretion parameters have not been extensively characterized due to the localized mode of delivery. This pharmacokinetic profile supports its safety for topical use, with systemic toxicity rarely observed. Nevertheless, potential adverse effects include local irritation, hypersensitivity reactions, or contact dermatitis. Appropriate safety evaluation should consider these factors, especially in sensitive populations.
Isoconazole is categorized under antifungal agents indicated for dermatological and gynecological use, including topical imidazole and triazole derivatives. It is commonly formulated as creams, ointments, or vaginal suppositories. The API’s inclusion in approved drug products reinforces its established role in antifungal therapy.
From an API sourcing perspective, quality assurance should focus on compliance with pharmacopeial standards, including purity, residual solvents, and microbial limits. Given its azole chemical class, attention to stereochemical integrity and absence of related impurities is critical. Reliable suppliers must provide detailed certificates of analysis and demonstrate adherence to Good Manufacturing Practices (GMP).
Identification & chemistry
| Generic name | Isoconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 27523-40-6 |
| UNII | GRI7WFR424 |
| DrugBank ID | DB08943 |
Formulation & handling
- Isoconazole is a small molecule antifungal primarily formulated for topical and vaginal administration, not suitable for oral or injectable routes.
- The compound exhibits very low water solubility and high lipophilicity (LogP 5.96), suggesting formulation strategies to enhance solubility and bioavailability may be needed.
- Formulations should consider stability and handling as a solid benzylether compound with potential sensitivity to moisture due to low aqueous solubility.
Regulatory status
Isoconazole is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Isoconazole (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Isoconazole API manufacturers & distributors
Compare qualified Isoconazole API suppliers worldwide. We currently have 2 companies offering Isoconazole API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Erregierre | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 44 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP | 63 products |
When sending a request, specify which Isoconazole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Isoconazole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
