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Besifloxacin | CAS No: 141388-76-3 | GMP-certified suppliers
A medication that treats bacterial conjunctivitis by targeting susceptible gram-positive and gram-negative ocular pathogens for effective anti-infective ophthalmic therapy.
Therapeutic categories
Primary indications
- Treatment of bacterial conjunctivitis
- Bacterial isolates that are susceptible to besifloxacin include: CDC coryneform group G
- Corynebacterium pseudodiphtheriticum
- Corynebacterium striatum
Product Snapshot
- Besifloxacin is formulated as an ophthalmic suspension for topical application
- It is primarily indicated for the treatment of bacterial conjunctivitis caused by susceptible bacterial strains
- Besifloxacin is approved for use in the US and Canadian regulatory markets
Clinical Overview
Structurally, besifloxacin belongs to the quinoline carboxylic acid class, characterized by a quinoline ring substituted with one or more carboxyl groups. Its mechanism of action involves dual inhibition of bacterial DNA gyrase and topoisomerase IV enzymes. By blocking DNA gyrase, besifloxacin disrupts bacterial DNA replication, transcription, and repair processes. Concurrent inhibition of topoisomerase IV interferes with chromosome decatenation during cell division. This dual targeting contributes to its bactericidal activity and may reduce the propensity for resistance development.
Pharmacokinetically, besifloxacin achieves tear concentrations exceeding the minimum inhibitory concentration (MIC90) for common ocular pathogens, with effective concentrations sustained for 24 hours or more after topical administration. The mean residence time in conjunctival tissue is approximately 4.7 hours, providing prolonged antibacterial coverage. Systemic absorption is minimal following ophthalmic application, limiting systemic exposure.
From a safety perspective, besifloxacin is generally well tolerated when administered as directed. Given its classification as a moderate risk QTc-prolonging agent, caution may be warranted in patients with cardiac conduction abnormalities or those using concomitant QTc-prolonging drugs. As with other fluoroquinolones, potential adverse effects may include local irritation or hypersensitivity reactions.
Besifloxacin is marketed under various ophthalmic brand names globally and is predominantly used in topical formulations for bacterial conjunctivitis. When sourcing besifloxacin API, attention to quality attributes such as purity, polymorphic form, and residual solvents is essential. Compliance with pharmacopeial monographs and regulatory standards ensures suitability for formulation development and clinical use.
Identification & chemistry
| Generic name | Besifloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 141388-76-3 |
| UNII | BFE2NBZ7NX |
| DrugBank ID | DB06771 |
Pharmacology
| Summary | Besifloxacin is a bactericidal fluoroquinolone antibiotic targeting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and cell division. Inhibition of these enzymes disrupts bacterial DNA processes and reduces resistance development. The compound achieves sustained antibacterial concentrations in ocular tissues, supporting its use in bacterial conjunctivitis treatment. |
|---|---|
| Mechanism of action | Besifloxacin is a bactericidal fluroquinolone-type antibiotic that inhibits bacterial enzymes, DNA gyrase and topoisomerase IV. By inhibiting DNA gyrase, DNA replication, transcription, and repair is impaired. By inhibiting topoisomerase IV, decatenation during cell devision is impaired. Inhibiting these two targets also slows down development of resistance. |
| Pharmacodynamics | Besifloxacin tear concentrations were higher than MIC90 (minimum inhibitory concentration) values for common bacterial pathogens and sustained for 24 hours or longer. Mean residence time in the conjunctiva was 4.7 hours. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA topoisomerase 4 subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | antagonist |
| DNA topoisomerase 4 subunit A | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | antagonist |
| DNA gyrase subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | antagonist |
ADME / PK
| Absorption | Although ocular surface concentrations are high, average systemic concentrtions after three-times daily dosing was less than 0.5 ng/mL. This indicates that besifloxacin is not appreciably absorbed into the systemic and has a very low risk of systemic side effects. |
|---|---|
| Half-life | The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours. |
| Protein binding | None |
| Metabolism | No appreciable metabolism |
| Route of elimination | N/A |
| Volume of distribution | Not absorbed into the systemic |
| Clearance | N/A |
Formulation & handling
- Besifloxacin is a small molecule quinoline carboxylic acid primarily formulated for ophthalmic suspension use.
- Its aqueous solubility is low, necessitating suspension formulations for effective ocular delivery.
- The compound’s stability and handling require protection from contamination due to its liquid suspension form for topical eye application.
Regulatory status
| Lifecycle | The API is marketed in the US and Canada and has key patent protections in the United States expiring between 2012 and 2030, indicating a market in transition with both established and emerging intellectual property rights. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Besifloxacin is primarily supplied by originator companies with branded products focused on the US and Canadian markets. The presence of multiple US patents, with expiration dates extending through 2029 and 2030, indicates ongoing patent protection and limited current generic competition in these regions. The supply landscape is therefore characterized by a consolidated originator presence with brand exclusivity maintained in North America. |
|---|
Safety
| Toxicity | LD50, rat: >2000 mg/kg. The most common adverse reaction reported in 2% of patients treated with besifloxacin was conjunctival redness. |
|---|
- 1
- Oral LD50 in rats exceeds 2000 mg/kg, indicating low acute systemic toxicity
- 2
Besifloxacin 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.
Besifloxacin API manufacturers & distributors
Compare qualified Besifloxacin API suppliers worldwide. We currently have 6 companies offering Besifloxacin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Indoco Remedies | Producer | India | India | CoA, USDMF | 19 products |
| Micro Labs | Producer | India | India | CoA, USDMF | 38 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
When sending a request, specify which Besifloxacin 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 Besifloxacin 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.
