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Nitrofural | CAS No: 59-87-0 | GMP-certified suppliers
A medication that treats bacterial skin infections and supports wound healing in burns, cuts, ulcers, and resistant cases, with antibacterial and antiparasitic properties for topical use.
Therapeutic categories
Primary indications
- For the treatment of bacterial skin infections including pyodermas, infected dermatoses and infections of cuts, wounds, burns and ulcers due to susceptible organisms
Product Snapshot
- Nitrofural is available in various topical formulations including ointments, solutions, inserts, suppositories, creams, and drops for auricular, ophthalmic, vaginal, and cutaneous routes
- It is primarily indicated for the treatment of bacterial skin infections such as pyodermas, infected dermatoses, and infections of cuts, wounds, burns, and ulcers from susceptible organisms
- The product has mixed approval status with some formulations approved for human and veterinary use, others investigational, and some withdrawn from the market
Clinical Overview
Pharmacodynamically, nitrofural is indicated as an adjunctive therapy in second and third degree burns, particularly in cases where resistance to other antibacterial agents presents a clinical challenge. It is also utilized in skin grafting procedures to prevent bacterial contamination that could result in graft rejection or donor site infection, especially in hospital environments with documented resistant bacterial strains.
The precise mechanism of action of nitrofural remains incompletely elucidated. It is understood to inhibit multiple bacterial enzymes involved in both aerobic and anaerobic glucose and pyruvate metabolism. Key enzymatic targets are believed to include pyruvate dehydrogenase, citrate synthetase, malate dehydrogenase, glutathione reductase, and pyruvate decarboxylase, disrupting essential bacterial metabolic pathways.
Key Absorption, Distribution, Metabolism, and Excretion (ADME) parameters specific to topical use are limited, as systemic absorption is generally minimal when nitrofural is applied to intact skin or superficial wounds. Oral administration has been studied but is not widely employed due to safety and regulatory considerations.
Safety and toxicity concerns have influenced regulatory status in various regions. The U.S. Food and Drug Administration has withdrawn approval for nitrofural-containing drug products except those intended for topical dermatologic use, reflecting potential systemic toxicity and carcinogenicity risks observed in certain preclinical studies. Monitoring for local hypersensitivity or irritation is advised during topical administration.
Notable branded formulations containing nitrofural are primarily topical dressings or ointments used in wound care and dermatologic applications. Its deployment is typically confined to clinical scenarios where resistance to other agents is problematic, or when targeted antiparasitic activity is required.
From an API sourcing and quality perspective, procurement should ensure compliance with pharmacopeial standards for purity, impurity profiles, and stability. Given the regulatory constraints and potential safety considerations associated with nitrofural, manufacturers and sourcing managers must verify batch certification, regulatory documentation, and suitability for the intended formulation and market. Controlled handling and appropriate labeling are critical due to the compound’s potential hazards.
Identification & chemistry
| Generic name | Nitrofural |
|---|---|
| Molecule type | Small molecule |
| CAS | 59-87-0 |
| UNII | X8XI70B5Z6 |
| DrugBank ID | DB00336 |
Pharmacology
| Summary | Nitrofurazone is a topical antibacterial agent targeting bacterial enzymes involved in aerobic and anaerobic glucose and pyruvate metabolism, including glutathione reductase. Its mechanism disrupts key enzymatic pathways critical for bacterial energy production and survival. It is primarily used to manage bacterial skin infections and prevent contamination in burns and skin grafts, particularly in cases involving resistant organisms. |
|---|---|
| Mechanism of action | The exact mechanism of action is unknown. Nitrofurazone inhibits several bacterial enzymes, especially those involved in the aerobic and anaerobic degradation of glucose and pyruvate. This activity is believed also to affect pyruvate dehydrogenase, citrate synthetase, malate dehydrogenase, glutathione reductase, and pyruvate decarboxylase. |
| Pharmacodynamics | Nitrofurazone is a topical antibacterial agent indicated as an adjunctive therapy for second and third degree burns when resistance to other agents is a real or potential problem. Nitrofurazone is also indicated in skin grafting when bacterial contamination may cause graft rejection or donor site infection, especially in hospitals with a history of resistant bacteria. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glutathione reductase | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Well absorbed. |
|---|---|
| Half-life | 5 hours |
| Metabolism | Nitrofurans, including nitrofural, undergo metabolic reduction at the nitro group to generate reactive species which can covalently bind to cellular macromolecules (Polnaszek et al., 1984; Kutcher & McCalla, 1984; McCalla 1979; McCalla et al., 1975). |
Formulation & handling
- Nitrofural is a small molecule primarily formulated for topical, auricular, ophthalmic, and vaginal administration rather than oral or injectable use.
- It exhibits low water solubility, requiring consideration in aqueous formulations to ensure adequate bioavailability and stability.
- Formulations must account for the nitrofuran moiety’s potential sensitivity to light and oxidation, suggesting protective packaging and handling conditions.
Regulatory status
Supply Chain
| Supply chain summary | Nitrofural is produced by multiple manufacturers, including several pharmaceutical companies primarily based in the USA. Branded products are available across the US and potentially other regions, supported by diverse packaging partners. Patent expiry has led to existing generic competition, as evidenced by the range of manufacturers offering the API. |
|---|
Safety
| Toxicity | Rat LD<sub>50</sub> = 590 mg/kg; Allergic contact dermatitis is the most frequently reported adverse effect, occurring in approximately 1 % of patients treated. |
|---|
- Acute toxicity LD50 (rat, oral): 590 mg/kg
- May cause allergic contact dermatitis upon dermal exposure
- Handle with appropriate protective equipment to minimize skin contact
Nitrofural is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Nitrofural API manufacturers & distributors
Compare qualified Nitrofural API suppliers worldwide. We currently have 3 companies offering Nitrofural API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Menadiona, S.L. | Producer | Spain | Spain | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 15 products |
| Shandong Fangxing Technol... | Producer | China | China | CoA | 5 products |
When sending a request, specify which Nitrofural 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 Nitrofural 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.
