- Raw materials
- Antibacterials
- Aminoglycosides
- Paromomycin
Paromomycin API Manufacturers & Suppliers
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Paromomycin | CAS No: 7542-37-2 | GMP-certified suppliers
A medication that treats acute and chronic intestinal amebiasis and supports hepatic coma management as adjunctive therapy with targeted intestinal antimicrobial activity.
Therapeutic categories
Primary indications
- For the treatment of acute and chronic intestinal amebiasis (it is not effective in extraintestinal amebiasis)
- Also for the management of hepatic coma as adjunctive therapy
Product Snapshot
- Paromomycin is available primarily as oral formulations including tablets, capsules, syrups, and powders for solution
- It is indicated for the treatment of acute and chronic intestinal amebiasis and as adjunctive therapy in hepatic coma management
- The product holds approval status in major regulatory markets including the US and Canada, with both approved and investigational designations
Clinical Overview
Clinically, paromomycin is indicated primarily for the treatment of acute and chronic intestinal amebiasis. It is important to note that paromomycin is ineffective against extraintestinal amebiasis. Additionally, it serves as adjunct therapy in the management of hepatic coma. Its antibacterial spectrum closely resembles that of neomycin, demonstrating broad efficacy against intestinal protozoa and certain bacterial pathogens.
The pharmacological action of paromomycin involves inhibition of protein synthesis. Specifically, it binds to the 16S ribosomal RNA within the 30S subunit of bacterial ribosomes, interfering with the translation process. Binding at the A site induces the production of aberrant polypeptides, leading to defective bacterial proteins. The accumulation of these faulty proteins ultimately results in bacterial cell death.
Regarding absorption, distribution, metabolism, and excretion (ADME), paromomycin is poorly absorbed from the gastrointestinal tract when administered orally, which enables high luminal concentrations in the gut while limiting systemic exposure. This property is central to its utility in intestinal infections, minimizing systemic toxicity. Paromomycin is excreted primarily unchanged via the feces; systemic clearance is minimal.
Safety considerations include warnings about nephrotoxicity and ototoxicity, consistent with aminoglycoside class effects, particularly when systemic absorption occurs or in higher doses. Its neuromuscular blocking potential is also documented, necessitating caution in susceptible populations. Adverse effects may include gastrointestinal disturbances due to local irritation.
Notable formulations containing paromomycin are utilized globally in regions endemic for amebiasis and other intestinal parasitic infections. Regulatory status varies by country, with paromomycin approved in several jurisdictions as an antiamebic and antiparasitic agent.
For pharmaceutical development and API procurement, attention should be directed toward stringent quality control parameters, including purity, polymorphism, and microbial contamination. Batch-to-batch consistency and compliance with pharmacopeial standards such as those from the USP or EP are critical to ensure therapeutic efficacy and safety. Suppliers should provide extensive documentation on sourcing, manufacturing processes, and stability data to support regulatory submissions.
Identification & chemistry
| Generic name | Paromomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 7542-37-2 |
| UNII | 61JJC8N5ZK |
| DrugBank ID | DB01421 |
Pharmacology
| Summary | Paromomycin is a broad-spectrum aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 16S ribosomal RNA within the 30S ribosomal subunit. This binding disrupts proper tRNA positioning, leading to the production of defective polypeptides and subsequent bacterial cell death. Its primary targets include components of the 30S and 40S ribosomal subunits, mediating antibacterial effects particularly against intestinal pathogens. |
|---|---|
| Mechanism of action | Paromomycin inhibits protein synthesis by binding to 16S ribosomal RNA. Bacterial proteins are synthesized by ribosomal RNA complexes which are composed of 2 subunits, a large subunit (50s) and small (30s) subunit, which forms a 70s ribosomal subunit. tRNA binds to the top of this ribosomal structure. Paramomycin binds to the A site, which causes defective polypeptide chains to be produced. Continuous production of defective proteins eventually leads to bacterial death. |
| Pharmacodynamics | Paromomycin is a broad spectrum aminoglycoside antibiotic produced by <i>Streptomyces rimosus</i> var. paromomycinus. The in vitro and in vivo antibacterial action of paromomycin closely parallels that of neomycin. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S10 | Thermus thermophilus (strain HB8 / ATCC 27634 / DSM 579) | inhibitor |
| 16S ribosomal RNA | Enteric bacteria and other eubacteria | inhibitor |
| 40S ribosomal protein SA | Humans | inhibitor |
ADME / PK
| Absorption | Poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool. |
|---|
Formulation & handling
- Paromomycin is a small molecule aminoglycoside antibiotic available in multiple oral dosage forms and injectable formulation.
- The API is highly water soluble and highly hydrophilic (LogP -8.3), indicating suitability for aqueous formulations.
- Oral formulations should be administered with food to optimize absorption and minimize gastrointestinal discomfort.
Regulatory status
| Lifecycle | The API's primary patent protection has expired in both the US and Canada, leading to increased availability of generic formulations in these markets. Consequently, the product is in a mature phase with established competition and market presence. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Paromomycin includes multiple packagers primarily serving the US and Canadian markets. Branded products, all under the name Humatin, have a notable presence in these regions. Patent expiry indicates the likelihood of existing or forthcoming generic competition in these markets. |
|---|
Paromomycin 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.
Paromomycin (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.
