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Amphotericin B | CAS No: 1397-89-3 | GMP-certified suppliers
A medication that treats life-threatening systemic fungal infections by providing broad-spectrum antifungal activity essential for invasive fungal disease management.
Therapeutic categories
Primary indications
- Used to treat potentially life threatening fungal infections
Product Snapshot
- Amphotericin B is available in multiple formulation types including injectable liposomal forms, lyophilized powders for injection, oral suspensions, ointments, creams, and lozenges
- Its primary therapeutic use is for treating potentially life-threatening fungal infections
- This API is approved for use in the US and Canada, with some formulations also in investigational status
Clinical Overview
Pharmacodynamically, amphotericin B acts as either fungistatic or fungicidal depending on the concentration achieved in body fluids and the fungal strain’s susceptibility. The molecule belongs to the polyene class derived from aminoglycosides, characterized by amino-modified sugars. Its antifungal mechanism involves binding selectively and irreversibly to ergosterol, a key sterol component of fungal cell membranes. This binding induces pore formation, disrupting membrane integrity and causing leakage of intracellular components, ultimately leading to fungal cell death.
Absorption of amphotericin B after oral administration is minimal; it is typically administered intravenously for systemic infections. The drug demonstrates extensive tissue binding, particularly in the liver and spleen, with a prolonged half-life that supports sustained antifungal action. Despite its clinical utility, amphotericin B is associated with a narrow therapeutic index and notable toxicity, including nephrotoxicity and infusion-related reactions, which require careful monitoring during therapy.
Several formulations of amphotericin B exist, including conventional deoxycholate and lipid-based preparations, each varying in pharmacokinetics and safety profiles. Given its critical role in managing invasive fungal diseases, sourcing of high-quality amphotericin B API is essential. Procurement should focus on suppliers compliant with GMP standards, ensuring consistent purity, potency, and absence of contaminants to meet stringent regulatory and clinical performance requirements.
Identification & chemistry
| Generic name | Amphotericin B |
|---|---|
| Molecule type | Small molecule |
| CAS | 1397-89-3 |
| UNII | 7XU7A7DROE |
| DrugBank ID | DB00681 |
Pharmacology
| Summary | Amphotericin B is an antifungal agent targeting ergosterol in fungal cell membranes, leading to increased membrane permeability and cell death. Its fungistatic or fungicidal activity depends on drug concentration and fungal susceptibility. The drug exhibits broad-spectrum activity against various pathogenic fungi but is inactive against bacteria, rickettsiae, and viruses. |
|---|---|
| Mechanism of action | Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components. Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death. |
| Pharmacodynamics | Amphotericin B shows a high order of <i>in vitro</i> activity against many species of fungi. <i>Histoplasma capsulatum</i>, <i>Coccidioides immitis</i>, <i>Candida species</i>, <i>Blastomyces dermatitidis</i>, <i>Rhodotorula</i>, <i>Cryptococcus neoformans</i>, <i>Sporothrix schenckii</i>, <i>Mucor mucedo</i>, and <i>Aspergillus fumigatus</i> are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL <i>in vitro</i>. While <i>Candida albicans</i> is generally quite susceptible to amphotericin B, non-<i>albicans</i> species may be less susceptible. <i>Pseudallescheria boydii</i> and <i>Fusarium</i> sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Ergosterol | Candida albicans | binder |
ADME / PK
| Absorption | Bioavailability is 100% for intravenous infusion. |
|---|---|
| Half-life | An elimination half-life of approximately 15 days follows an initial plasma half-life of about 24 hours. |
| Protein binding | Highly bound (>90%) to plasma proteins. |
| Metabolism | Exclusively renal |
| Clearance | * 39 +/- 22 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 1 mg/kg/day at Day 1] * 17 +/- 6 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 1 mg/kg/day 3-20 days later] * 51 +/- 44 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 2.5 mg/kg/day at Day 1] * 22 +/- 15 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 2.5 mg/kg/day 3-20 days later] * 21 +/- 14 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 5 mg/kg/day at Day 1] * 11 +/- 6 mL/hr/kg [febrile neutropenic cancer and bone marrow transplant patients receiving infusion of 5 mg/kg/day 3-20 days later] |
Formulation & handling
- Amphotericin B is primarily formulated for intravenous administration due to its poor oral bioavailability, with additional topical and vaginal forms available.
- As a small molecule aminoglycoside with low water solubility, it often requires lipid-based formulations or lyophilized powders for reconstitution to enhance stability and delivery.
- Handling requirements include protection from light and moisture to maintain potency, especially for lyophilized and lipid complex injections.
Regulatory status
| Lifecycle | The API is marketed in the US and Canada with key patents expiring between 2012 and 2019, indicating that the product is in a mature market phase with potential for generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Amphotericin B is manufactured by multiple companies, including original originators and generic producers, reflecting a diverse manufacturing landscape. Its branded products, such as Abelcet and AmBisome, are primarily marketed in the US and Canada. Patent expirations between 2014 and 2019 indicate the presence of established generic competition in these markets. |
|---|
Safety
| Toxicity | Oral, rat: LD<sub>50</sub> = >5 gm/kg. Amphotericin B overdoses can result in cardio-respiratory arrest. |
|---|
- Oral LD50 in rats is greater than 5 g/kg, indicating low acute oral toxicity
- Overdose risk includes cardio-respiratory arrest
- Appropriate handling and dosing controls are recommended
Amphotericin B 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.
Amphotericin B (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.
Amphotericin B API manufacturers & distributors
Compare qualified Amphotericin B API suppliers worldwide. We currently have 8 companies offering Amphotericin B API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CoA, GMP | 36 products |
| Asence Pharma | Producer | India | India | CoA, WC | 6 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 235 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, Other, WC | 170 products |
| Jiwan Pharmaceutical Tech... | Producer | China | China | CoA, GMP, MSDS, USDMF | 8 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 762 products |
| Xellia | Producer | Denmark | Unknown | CEP, CoA, FDA, GMP, USDMF | 9 products |
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