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Framycetin | CAS No: 119-04-0 | GMP-certified suppliers
A medication that treats bacterial ocular infections such as blepharitis, conjunctivitis, corneal ulcers, and prevents infections after foreign body removal in ophthalmic care.
Therapeutic categories
Primary indications
- For the treatment of bacterial blepharitis, bacterial bonjunctivitis, corneal injuries, corneal ulcers and meibomianitis
- For the prophylaxis of ocular infections following foreign body removal
Product Snapshot
- Framycetin is available in multiple formulation types including topical ointments, ophthalmic solutions/drops, auricular (otic) solutions, nasal sprays, and rectal suppositories
- It is primarily indicated for the treatment and prophylaxis of bacterial infections affecting ocular and related sites such as bacterial blepharitis, conjunctivitis, corneal injuries, ulcers, and meibomianitis
- Framycetin is approved for use in the Canadian pharmaceutical market
Clinical Overview
Pharmacodynamically, framycetin exhibits bactericidal activity predominantly against aerobic Gram-positive and some Gram-negative bacteria. It lacks efficacy against fungal organisms, viruses, and most anaerobic bacteria. The antibacterial action of framycetin is mediated through binding to the bacterial 30S ribosomal subunit, specifically interacting with 16S rRNA and proteins including S12. This binding disrupts the decoding site near nucleotide 1400 of 16S rRNA, interfering with the initiation complex and causing the misreading of mRNA. As a result, framycetin induces the incorporation of incorrect amino acids into nascent polypeptides, leading to the production of nonfunctional or toxic proteins and disassembly of polysomes into inactive monosomes, which impairs bacterial protein synthesis and growth.
Key absorption, distribution, metabolism, and excretion (ADME) data for topical ophthalmic administration highlight a localized site of action with minimal systemic absorption. Due to its aminoglycoside class, framycetin carries potential nephrotoxicity and ototoxicity risks primarily when systemic exposure occurs, although these adverse effects are uncommon in topical use. Caution is advised in patients with known hypersensitivity to aminoglycosides.
Framycetin is available in various ophthalmic formulations and is included in medicated dressings targeting bacterial infections. It is generally recognized as an approved agent in many global markets for indicated ocular infections.
From a sourcing perspective, framycetin API procurement should ensure compliance with pharmacopeial standards concerning purity, microbial limits, and absence of endotoxins, given its ophthalmic application. Suppliers should provide comprehensive certificates of analysis and documentation supporting adherence to regulatory guidelines for aminoglycoside antibiotics to maintain quality and safety in finished formulations.
Identification & chemistry
| Generic name | Framycetin |
|---|---|
| Molecule type | Small molecule |
| CAS | 119-04-0 |
| UNII | 4BOC774388 |
| DrugBank ID | DB00452 |
Pharmacology
| Summary | Framycetin is an antibiotic targeting bacterial 30S ribosomal subunit components, including 16S rRNA and protein S12, disrupting the decoding site involved in mRNA translation. This action induces misreading of mRNA, leading to synthesis of nonfunctional proteins and inhibition of bacterial growth. It is primarily indicated for the treatment and prophylaxis of aerobic bacterial eye infections. |
|---|---|
| Mechanism of action | Framycetin binds to specific 30S-subunit proteins and 16S rRNA, four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes. |
| Pharmacodynamics | Framycetin is used for the treatment of bacterial eye infections such as conjunctivitis. Framycetin is an antibiotic. It is not active against fungi, viruses and most kinds of anaerobic bacteria. Framycetin works by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Framycetin is useful primarily in infections involving aerobic bacteria bacteria. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 16S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | inhibitor |
| C-X-C chemokine receptor type 4 | Humans | antagonist |
Formulation & handling
- Framycetin is a small molecule aminoglycoside primarily formulated for topical, ophthalmic, auricular, nasal, and rectal administration.
- Due to its hydrophilic nature and low LogP, it exhibits high water solubility, facilitating formulation in aqueous solutions and ointments.
- Formulation considerations include protecting the compound from moisture and maintaining sterility for ophthalmic and otic solutions.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has reached patent expiry in Canada, allowing for generic product entry and increased market competition. As a result, the product is in a mature market phase with established availability across multiple manufacturers. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Framycetin involves multiple originator companies with packaging activities by Amend and Teva Pharmaceutical Industries Ltd. Branded products are primarily present in the Canadian market, including various formulations such as ointments and suppositories. The information suggests that patent expiry has allowed for existing generic competition in this region. |
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Framycetin is a type of Aminoglycosides
Aminoglycosides are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in combating bacterial infections. These powerful antibiotics are primarily used to treat severe infections caused by gram-negative bacteria. Aminoglycosides are characterized by their unique chemical structure, consisting of amino sugars and a glycosidic bond.
These antibiotics exert their therapeutic effects by inhibiting bacterial protein synthesis, leading to the disruption of essential cellular functions in the bacteria. This mechanism of action makes aminoglycosides highly effective against a wide range of bacteria, including those that have developed resistance to other classes of antibiotics.
Key examples of aminoglycosides include gentamicin, amikacin, and tobramycin. These drugs are typically administered intravenously or intramuscularly to ensure optimal absorption and distribution throughout the body. Due to their limited oral bioavailability, aminoglycosides are not commonly administered orally.
Although aminoglycosides possess potent antimicrobial properties, they are associated with some potential adverse effects, including nephrotoxicity and ototoxicity. Regular monitoring of kidney function and therapeutic drug monitoring are often recommended during aminoglycoside therapy to minimize the risk of these complications.
In summary, aminoglycosides are an important subcategory of pharmaceutical APIs that have significant therapeutic value in the treatment of severe bacterial infections. Their unique mechanism of action and broad spectrum of activity make them valuable tools in the fight against antibiotic-resistant bacteria.
Framycetin (Aminoglycosides), classified under 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.
