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Sulbactam | CAS No: 68373-14-8 | GMP-certified suppliers
A medication that, combined with beta-lactam antibiotics, treats skin, intra-abdominal, gynecological infections, and hospital-acquired pneumonia caused by susceptible bacterial strains.
Therapeutic categories
Primary indications
- Sulbactam is used in combination with other antibacterial agents
- With [ampicillin], it is used to treat skin and skin structure infections, intra-abdominal infections, and gynecological infections caused by susceptible bacteria
- In combination with [durlobactam], sulbactam is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of _Acinetobacter baumannii-calcoaceticus_ complex
Product Snapshot
- Sulbactam is available primarily as an injectable powder for solution or suspension and oral tablets, classified as a beta-lactamase inhibitor used in combination formulations
- It is indicated for the treatment of bacterial infections including skin and skin structure infections, intra-abdominal and gynecological infections, as well as hospital-acquired and ventilator-associated bacterial pneumonia caused by specific bacteria
- Sulbactam-containing products are FDA approved and marketed in the United States
Clinical Overview
Clinically, sulbactam is indicated in combination with ampicillin for the treatment of a variety of infections including skin and skin structure infections, intra-abdominal infections, and gynecological infections caused by susceptible bacterial strains. More recently, sulbactam in combination with durlobactam has been approved for treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) due to susceptible Acinetobacter baumannii-calcoaceticus complex isolates in adult patients.
Pharmacodynamically, sulbactam enhances the activity of beta-lactam antibiotics by irreversibly and competitively inhibiting bacterial beta-lactamases, enzymes responsible for hydrolyzing and inactivating beta-lactam antibacterials. Sulbactam exhibits more potency against class C beta-lactamases. Although its intrinsic antibacterial action is weak, sulbactam can bind penicillin-binding proteins and shows some activity against Neisseriaceae, Acinetobacter species, and Bacteroides fragilis.
Pharmacokinetic and ADME data indicate that sulbactam is primarily excreted renally, with elimination largely dependent on renal function. This necessitates dosage adjustment in patients with impaired kidney function to avoid accumulation and potential toxicity.
Safety considerations for sulbactam align with those typical of beta-lactamase inhibitors and beta-lactam antibiotics, including the potential for hypersensitivity reactions, gastrointestinal disturbances, and, rarely, hematologic effects. Monitoring for allergic responses and renal function during therapy is advised.
From a sourcing and quality perspective, sulbactam API procurement requires confirmation of purity, stability, and compliance with current good manufacturing practices (cGMP). Given sulbactam’s role as a beta-lactamase inhibitor used in critical antibiotic combinations, ensuring consistent bioactivity and minimal impurities is essential for therapeutic efficacy and regulatory acceptance.
Identification & chemistry
| Generic name | Sulbactam |
|---|---|
| Molecule type | Small molecule |
| CAS | 68373-14-8 |
| UNII | S4TF6I2330 |
| DrugBank ID | DB09324 |
Pharmacology
| Summary | Sulbactam is a beta-lactamase inhibitor that competitively and irreversibly binds bacterial beta-lactamase enzymes, particularly class C variants, to prevent hydrolysis of beta-lactam antibiotics. This action broadens the antibacterial spectrum of co-administered beta-lactams by restoring their efficacy against beta-lactamase-producing gram-positive and gram-negative bacteria. Sulbactam also exhibits limited intrinsic antibacterial activity through binding to penicillin-binding proteins in select bacterial species. |
|---|---|
| Mechanism of action | Sulbactam is a competitive, irreversible bacterial beta (β)-lactamase inhibitor. It is reported to be more potent against class C beta-lactamases. |
| Pharmacodynamics | When given together with beta-lactam antibiotics, sulbactam broadens their antibacterial spectrum by blocking the enzyme involved in their hydrolysis. Sulbactam alone possesses weak intrinsic antibacterial activity except against the _Neisseriaceae_, _Acinetobacter spp._, and _Bacteroides fragilis_ as it can bind to the penicillin-binding proteins.[A220863, A263301] Sulbactam restores the activity of beta-lactam antibiotics against a range of beta-lactamase-producing gram-positive and gram-negative bacteria. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-lactamase | Staphylococcus aureus | inhibitor |
ADME / PK
| Absorption | Sulbactam is poorly absorbed after oral administration. Peak serum concentrations of ampicillin and sulbactam are reached following a 15-minute intravenous infusion. After the intravenous administration of 2000 mg of ampicillin plus 1000 mg sulbactam, peak sulbactam serum levels corresponded to 48 to 88 mcg/mL. After the intravenous administration of 1000 mg ampicillin plus 500 mg sulbactam, peak sulbactam serum levels corresponded to 21 to 40 mcg/mL. After an intramuscular injection of 1000 mg ampicillin plus 500 mg sulbactam, peak sulbactam serum levels ranged from 6 to 24 mcg/mL. |
|---|---|
| Half-life | In healthy volunteers, the half-life is approximately one hour. |
| Protein binding | Sulbactam is approximately 38% reversibly bound to plasma proteins. |
| Metabolism | Metabolism of sulbactam has not been characterized. |
| Route of elimination | When given in combination with ampicillin in individuals with normal renal function, approximately 75 to 85% of the drug is excreted unchanged in the urine during the first eight hours after administration. |
| Volume of distribution | The steady-state volumes of distribution range from 12.2 to 16.3 L. Sulbactam exhibits extensive distribution in extracellular fluids and tissues. Penetration of sulbactam into cerebrospinal fluid is enhanced in the presence of inflamed meninges. |
| Clearance | Eenal clearance is approximately 12 L/h following infusion over 15 to 30 minutes. |
Formulation & handling
- Sulbactam is a small molecule alpha amino acid derivative primarily formulated for parenteral administration via intramuscular or intravenous injection. It is also available in oral and topical ophthalmic forms, indicating moderate stability across diverse delivery routes. The compound’s high water solubility and low logP value suggest handling considerations for aqueous-based formulation and limited lipophilicity.
Regulatory status
| Lifecycle | The API is currently protected by multiple patents in the United States expiring between April 2033 and November 2035, indicating a mid-to-late lifecycle stage with ongoing market exclusivity. Commercial products utilizing this API are primarily marketed in the US. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The Sulbactam supply landscape involves multiple originator companies producing branded combination products primarily in the US market. Existing patents with expiration dates extending to 2033 and beyond indicate ongoing patent protection, suggesting limited current generic competition. This patent status may influence the timeline for future entry of generic manufacturers. |
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Safety
| Toxicity | The oral LD<sub>50</sub> of sulbactam sodium is >4000 mg/kg in rats and >10,000 mg/kg in mice. The intravenous LD<sub>50</sub> of sulbactam sodium is 4582 mg/kg in rats and 3604 mg/kg in mice. There is no information on the clinical signs and symptoms associated with a sulbactam overdose. Neurological adverse reactions, including convulsions, may occur. While sulbactam is removable by hemodialysis, there is limited clinical information regarding the use of hemodialysis to treat overdosage. |
|---|
- Sulbactam sodium exhibits low acute toxicity with oral LD50 values exceeding 4000 mg/kg in rodents
- Neurological adverse effects, including convulsions, have been reported in overdose scenarios
- Sulbactam can be partially removed via hemodialysis, though clinical data on this treatment approach are limited
Sulbactam is a type of Beta-lactamase inhibitors
Beta-lactamase inhibitors are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in combating antibiotic resistance. These inhibitors are compounds specifically designed to enhance the effectiveness of beta-lactam antibiotics, which are widely used to treat bacterial infections. By inhibiting beta-lactamase enzymes, which are produced by bacteria to neutralize the activity of beta-lactam antibiotics, beta-lactamase inhibitors help restore the efficacy of these antibiotics.
The mechanism of action of beta-lactamase inhibitors involves binding to beta-lactamase enzymes, preventing them from inactivating beta-lactam antibiotics. This allows the antibiotics to effectively target and eliminate bacteria that would otherwise be resistant to their activity. By combining beta-lactamase inhibitors with beta-lactam antibiotics, healthcare professionals can overcome antibiotic resistance, expanding the range of infections that can be effectively treated.
Some commonly used beta-lactamase inhibitors include clavulanic acid, sulbactam, and tazobactam. These inhibitors are often formulated in combination with beta-lactam antibiotics, such as penicillins and cephalosporins, to create powerful therapeutic agents.
The development of beta-lactamase inhibitors is a critical strategy in the fight against antibiotic resistance, as it helps to extend the lifespan of existing antibiotics. By leveraging these inhibitors, healthcare providers can continue to use beta-lactam antibiotics effectively and combat infections caused by drug-resistant bacteria. Ongoing research and development efforts in this subcategory of pharmaceutical APIs are aimed at improving the efficacy and safety profiles of beta-lactamase inhibitors, thereby addressing the global challenge of antibiotic resistance.
Sulbactam (Beta-lactamase inhibitors), 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.
Sulbactam API manufacturers & distributors
Compare qualified Sulbactam API suppliers worldwide. We currently have 8 companies offering Sulbactam 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 |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CoA, JDMF, USDMF | 36 products |
| Eumedica Pharmaceuticals | Producer | Spain | Spain | CoA, JDMF | 1 products |
| Qilu Tianhe | Producer | China | China | CoA, USDMF, WC | 16 products |
| Shin Poong Pharm | Producer | South Korea | South Korea | CoA, JDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Yuhan Chemical | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF, WC | 69 products |
| Zhuhai United Labs | Producer | China | China | CoA, WC | 12 products |
When sending a request, specify which Sulbactam 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 Sulbactam 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.
