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Colistin | CAS No: 1066-17-7 | GMP-certified suppliers
A medication that treats acute and chronic infections caused by susceptible gram-negative bacilli, including multidrug-resistant Pseudomonas aeruginosa, with a focus on systemic antibacterial efficacy.
Therapeutic categories
Primary indications
- For the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli, particularly <i>Pseudomonas aeruginosa</i>
Product Snapshot
- Colistin is available primarily as injectable powder for solution, oral tablets, granules, suspensions, and auricular (otic) solutions
- It is indicated for the treatment of acute or chronic infections caused by sensitive gram-negative bacilli, notably Pseudomonas aeruginosa
- The product is approved for use in the US market
Clinical Overview
Clinically, colistin is indicated for the treatment of acute or chronic infections caused by susceptible strains of gram-negative bacilli, with a particular emphasis on Pseudomonas aeruginosa. Its therapeutic use is especially relevant in the management of multidrug-resistant infections where alternative antimicrobial agents have limited efficacy.
The pharmacological action of colistin involves its cationic polymyxin structure, which interacts with the bacterial cytoplasmic membrane. This interaction disrupts membrane integrity by altering permeability through a detergent-like mechanism, resulting in bacterial cell death. Additionally, evidence suggests polymyxins may penetrate bacterial cells and precipitate cytoplasmic components, including ribosomes, contributing to their bactericidal effect.
Pharmacokinetically, colistin is predominantly cleared by renal excretion. It exhibits a narrow therapeutic index and has well-documented nephrotoxic potential, necessitating careful dosing and monitoring. The methanesulfonate derivative of colistin is used for oral administration, whereas parenteral forms are reserved for severe infections due to concerns surrounding systemic toxicity.
Colistin is approved for clinical use and classified among aminoglycoside antibacterials, antimicrobial peptides, and agents known to cause neuromuscular blockade indirectly. Its resurgence in clinical practice aligns with the increasing prevalence of multidrug-resistant gram-negative pathogens, including Pseudomonas aeruginosa and Acinetobacter baumannii.
From an API sourcing perspective, quality control is critical given colistin’s narrow therapeutic index and toxicity profile. Suppliers should ensure compliance with pharmacopeial standards and confirm the purity and potency of the colistin generated, particularly regarding the proportions of polymyxin E1 and E2 components and the absence of contaminants that could influence safety or efficacy in pharmaceutical formulations.
Identification & chemistry
| Generic name | Colistin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1066-17-7 |
| UNII | Z67X93HJG1 |
| DrugBank ID | DB00803 |
Pharmacology
| Summary | Colistin is a polymyxin antibiotic that targets the outer membrane of gram-negative bacteria, disrupting membrane integrity through a surface-active, detergent-like mechanism. This interaction increases membrane permeability, leading to bactericidal effects. Colistin is primarily used against multidrug-resistant gram-negative pathogens such as Pseudomonas aeruginosa. |
|---|---|
| Mechanism of action | Colistin is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistin is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes. |
| Pharmacodynamics | Colistin is a polymyxin antibiotic agent. Polymyxins are cationic polypeptides that disrupt the bacterial cell membrane through a detergentlike mechanism. With the development of less toxic agents, such as extended-spectrum penicillins and cephalosporins, parenteral polymyxin use was largely abandoned, except for the treatment of multidrug-resistant pulmonary infections in patients with cystic fibrosis. More recently, however, the emergence of multidrug-resistant gram-negative bacteria, such as <i>Pseudomonas aeruginosa</i> and <i>Acinetobacter baumannii</i>, and the lack of new antimicrobial agents have led to the revived use of the polymyxins. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Bacterial outer membrane | Bacteria | incorporation into and destabilization |
ADME / PK
| Absorption | Very poor absorption from gastrointestinal tract. |
|---|---|
| Half-life | 5 hours |
| Metabolism | As 80% of the dose can be recovered unchanged in the urine, and there is no biliary excretion, it can be assumed that the remaining drug is inactivated in the tissues, however the mechanism is unknown. |
Formulation & handling
- Colistin is a cyclic peptide small molecule available in oral, injectable, and otic dosage forms, requiring formulation consideration for route-specific stability. Due to its low water solubility and peptide backbone, solubilization strategies and protection from enzymatic degradation are important in oral formulations. Injectable powder forms must be reconstituted properly to maintain potency and sterility, with handling conditions minimizing exposure to moisture.
Regulatory status
| Lifecycle | The API's primary patent protection in the US is set to expire within the next 12 months, positioning it in a late lifecycle phase with increasing generic competition. Market activity is expected to shift towards cost-competitive alternatives post-patent expiry. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Colistin is manufactured by originator companies such as Parke Davis Div Warner Lambert Co and packaged by entities including Paddock Labs, primarily serving the US market. Branded products like Coly-Mycin S and Cortisporin TC have a presence mainly in the US, with no specific mention of EU or other regional markets. Patent expiration has led to the availability of generic versions, indicating existing generic competition in the marketplace. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> in rats is 5450 mg/kg. Overdosage with colistimethate can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. |
|---|
- Oral LD50 in rats is 5450 mg/kg, indicating moderate acute toxicity
- Overexposure may induce neuromuscular blockade presenting as paresthesia, ataxia, and respiratory depression
- Respiratory muscle paralysis can result in apnea and respiratory arrest
Colistin 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.
Colistin API manufacturers & distributors
Compare qualified Colistin API suppliers worldwide. We currently have 9 companies offering Colistin 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, HALAL, ISO14001, ISO9001, Kosher, MSDS | 250 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Netherlands | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Hebei Shengxue Dacheng | Producer | China | China | CEP, CoA, FDA, GMP | 4 products |
| Jiangsu Sel Biochem | Producer | China | China | CEP, CoA, FDA, GMP | 1 products |
| Lifecome Biochemistry | Producer | China | China | CEP, CoA, FDA, GMP | 1 products |
| Meiji Pharma | Producer | China | China | CEP, CoA, GMP | 1 products |
| Xellia | Producer | Denmark | Unknown | CEP, CoA, FDA, GMP, USDMF | 9 products |
| Zhejiang Shenghua B.B. | Producer | China | China | CEP, CoA | 1 products |
When sending a request, specify which Colistin 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 Colistin 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.
