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Spectinomycin | CAS No: 1695-77-8 | GMP-certified suppliers
A medication that treats acute gonorrheal infections in males and females by targeting susceptible Neisseria gonorrhoeae strains with systemic antibacterial activity.
Therapeutic categories
Primary indications
- For use in the treatment of acute gonorrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of <i>Neisseria gonorrhoeae</i>
Product Snapshot
- Spectinomycin is available as a powder for solution and injectable solutions formulated for intramuscular and oral administration
- It is indicated primarily for the treatment of gonococcal infections including urethritis, cervicitis, and proctitis caused by susceptible Neisseria gonorrhoeae strains
- Spectinomycin holds approval status in the US and Canada for human use, with some investigational and veterinary approvals
Clinical Overview
Pharmacodynamically, spectinomycin demonstrates activity against most strains of N. gonorrhoeae, with minimum inhibitory concentrations typically ranging from 7.5 to 20 mcg/mL in vitro. Mechanistically, its antimicrobial effect results from inhibition of bacterial protein synthesis by binding to the 30S ribosomal subunit. This interaction disrupts ribosomal function and impairs translation, leading to a bactericidal effect.
Spectinomycin is classified chemically within organic compounds known as 1,4-dioxanes, specifically featuring a six-membered aliphatic ring containing two oxygen atoms at positions 1 and 4. It is included within drug categories such as anti-bacterial agents and systemic anti-infectives.
Key absorption, distribution, metabolism, and excretion (ADME) details for spectinomycin are limited in the provided data; however, its use is well established in systemic antibacterial therapy. Safety considerations include potential toxicity profiles relevant to systemic administration, though detailed safety and toxicity data should be consulted from regulatory documents and pharmacovigilance sources. The drug has been approved for human use and is also recognized in veterinary applications under investigational or approved status.
Notable formulations are typically parenteral, designed for rapid attainment of therapeutic drug levels at infection sites. Spectinomycin has been used primarily in antimicrobial regimens targeting resistant gonococcal infections, especially where first-line agents are contraindicated.
For API procurement, sourcing spectinomycin requires attention to microbial fermentation quality, compliance with Good Manufacturing Practices (GMP), and confirmation of chemical identity including the structural criteria consistent with 1,4-dioxane derivatives. Robust impurity profiling and batch-to-batch consistency are critical to ensure efficacy and safety in clinical applications.
Identification & chemistry
| Generic name | Spectinomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1695-77-8 |
| UNII | 93AKI1U6QF |
| DrugBank ID | DB00919 |
Pharmacology
| Summary | Spectinomycin is a bactericidal aminocyclitol antibiotic that inhibits protein synthesis by binding to the 30S ribosomal subunit, specifically targeting ribosomal protein S12 in susceptible bacteria. It primarily acts against Neisseria gonorrhoeae by disrupting ribosomal function and protein assembly. This mechanism underlies its therapeutic use in treating acute gonococcal infections. |
|---|---|
| Mechanism of action | Spectinomycin is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. It is bactericidal in its action. |
| Pharmacodynamics | Spectinomycin is an aminocyclitol antibiotic produced by a species of soil microorganism designated as S<i>treptomyces spectabilis</i>. In vitro studies have shown spectinomycin to be active against most strains of <i>Neisseria gonorrhoeae</i> (minimum inhibitory concentration <7.5 to 20 mcg/mL). Footprint studies indicate that spectinomycin exerts regional effects on ribosomal structure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Rapidly and almost completely absorbed after intramuscular injection. |
|---|---|
| Half-life | 1 to 3 hours in patients with normal renal function and 10 to 30 hours in patients with impaired renal function with a creatinine clearance < 20 mL per minute. |
| Protein binding | Not significant |
Formulation & handling
- Spectinomycin is available for both oral and intramuscular administration, allowing flexibility in formulation design.
- As a small molecule with high water solubility and negative LogP, Spectinomycin formulations should prioritize aqueous stability and solubility enhancement.
- Injectable forms require reconstitution from powder, necessitating attention to sterility and proper dissolution prior to intramuscular administration.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the US and Canada, with patent protection expected to expire within the next 12 months. Following patent expiry, the API is anticipated to enter a mature market phase with increased generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Spectinomycin is manufactured by Pharmacia and Upjohn Co., with packaging handled by Pfizer Inc. and Pharmacia Inc. Branded products, such as Trobicin and Trobicin Inj 400 mg/ml, are primarily marketed in the US and Canadian markets. The presence of established originator companies in North America suggests a controlled supply landscape, with limited global branded product distribution and potential for generic competition depending on patent status. |
|---|
Safety
| Toxicity | Acute oral toxicity (LD<sub>50</sub>): >5000 mg/kg [Rat]. Information on overdosage in humans is not available. |
|---|
- Exhibits low acute oral toxicity with an LD₅₀ greater than 5000 mg/kg in rat models
- Lack of human overdosage data necessitates caution in handling and dosing accuracy
- Potential for adverse reactions related to sensitive populations should be evaluated during formulation
Spectinomycin 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.
Spectinomycin (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.
Spectinomycin API manufacturers & distributors
Compare qualified Spectinomycin API suppliers worldwide. We currently have 6 companies offering Spectinomycin API, with manufacturing taking place in 2 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, ISO9001, MSDS, WC | 250 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, USDMF | 235 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Shandong Lukang | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 4 products |
| Shandong Qilu King-Phar | Producer | China | China | CEP, CoA, GMP | 3 products |
| Zhejiang Jinhua Conba | Producer | China | China | CEP, CoA, FDA, GMP | 6 products |
When sending a request, specify which Spectinomycin 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 Spectinomycin 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.
