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Carbocisteine | CAS No: 638-23-3 | GMP-certified suppliers
A medication that facilitates mucus clearance and improves respiratory function in conditions with excessive airway secretions, such as chronic obstructive pulmonary disease and other respiratory disorders.
Therapeutic categories
Primary indications
- Carbocisteine is indicated over the counter and in prescription formulas to clear airway secretions in conditions associated with increased mucus
Product Snapshot
- Carbocisteine is an oral small molecule formulation available in multiple dosage forms including syrup, solution, powder, granule, suspension, gel, tablet, and capsule
- It is primarily indicated for clearing airway secretions in conditions with increased mucus production
- Carbocisteine is approved for use and also available in investigational status across various markets
Clinical Overview
Pharmacologically, carbocisteine belongs to the class of l-cysteine-s-conjugates, compounds containing L-cysteine with a conjugated thio-group. Its mechanism of action involves modulation of the viscoelastic properties of mucus through the restoration of balance between glycoproteins—specifically the reduction of overexpressed fucomucins and normalization of sialomucin levels. This effect is thought to result from intracellular stimulation of sialyl transferase activity. Additionally, carbocisteine blocks bacterial adherence to epithelial cells, thereby reducing the risk of pulmonary infections commonly seen in mucus accumulation states. In vitro studies indicate carbocisteine exhibits antioxidant properties by activating protein kinase B (Akt) phosphorylation, which may prevent oxidative cell damage and lung cell apoptosis. It also appears to suppress inflammatory signaling pathways involving NF-κB and ERK1/2 MAPK, and reduce expression of intracellular adhesion molecules, contributing to lower airway inflammation.
Key ADME parameters for carbocisteine are not extensively detailed in available literature; however, its therapeutic effects are predominantly localized within the respiratory tract following systemic absorption.
Safety considerations have led to withdrawal of carbocisteine licenses for pediatric use in some countries due to serious and fatal paradoxical respiratory events including aggravated dyspnea and cough. It is currently not approved by the FDA or Health Canada but is authorized for use in various Asian, European, and South American markets.
Quality and sourcing of carbocisteine as an active pharmaceutical ingredient (API) require rigorous control of purity and consistency due to its specific chemical structure as an L-cysteine conjugate. Suppliers should ensure compliance with pharmacopeial standards and thorough impurity profiling to support formulation and regulatory requirements globally.
Identification & chemistry
| Generic name | Carbocisteine |
|---|---|
| Molecule type | Small molecule |
| CAS | 638-23-3 |
| UNII | 740J2QX53R |
| DrugBank ID | DB04339 |
Pharmacology
| Summary | Carbocisteine acts primarily as a mucoregulatory agent by modulating glycoprotein composition in bronchial mucus, thereby reducing viscosity and improving mucus clearance in respiratory conditions characterized by hypersecretion. It targets enzymes involved in mucin synthesis, such as lactosylceramide alpha-2,3-sialyltransferase, and exhibits antioxidant and anti-inflammatory effects through inhibition of NF-κB and MAPK signaling pathways. Additionally, carbocisteine impairs bacterial adherence and viral infection mechanisms, contributing to reduced pulmonary infections and inflammation. |
|---|---|
| Mechanism of action | The hypersecretion of mucus characterizes serious respiratory conditions including asthma, cystic fibrosis (CF), and chronic obstructive pulmonary disease (COPD). It blocks bacterial adherence to cells, preventing pulmonary infections. Glycoproteins (fucomucins, sialomucins and sulfomucins) regulate the viscoelastic properties of bronchial mucus. Increased fucomucins can be found in the mucus of patients with COPD. Carbocisteine serves to restore equilibrium between sialomucins and fucomucins, likely by intracellular stimulation of sialyl transferase enzyme, thus reducing mucus viscosity. A study found that L-carbocisteine can inhibit damage to cells by hydrogen peroxide (H2O2) by activating protein kinase B (Akt) phosphorylation, suggesting that carbocisteine may have antioxidant effects and prevent apoptosis of lung cells. There is some evidence that carbocisteine suppresses NF-κB and ERK1/2 MAPK signalling pathways, reducing TNF-alpha induced inflammation in the lungs, as well as other inflammatory pathways. An in-vitro study found that L-carbocisteine reduces intracellular adhesion molecule 1 (ICAM-1), inhibiting rhinovirus 14 infection, thereby reducing airway inflammation. |
| Pharmacodynamics | Due to its mucolytic effects, carbocisteine significantly reduces sputum viscosity, cough, dyspnea and fatigue. Additionally, it prevents pulmonary infections by decreasing accumulated mucus in the respiratory tract; this is especially beneficial in preventing exacerbations of COPD caused by bacteria and viruses. It has in-vitro anti-inflammatory activity with some demonstrated action against free radicals. |
Targets
| Target | Organism | Actions |
|---|---|---|
| PI-PLC X domain-containing protein 3 | Humans | inhibitor |
| Lactosylceramide alpha-2,3-sialyltransferase | Humans | inducer |
ADME / PK
| Absorption | Carbocisteine is rapidly absorbed in the gastrointestinal tract when taken orally with peak serum concentrations achieved within 1 to 1.7 hours. |
|---|---|
| Half-life | The plasma half-life of carbicostine is 1.33 hours. |
| Protein binding | Plasma protein binding information for carbocisteine is not readily available in the literature. |
| Metabolism | Metabolic pathways for carbocisteine include acetylation, decarboxylation, and sulfoxidation, leading to the formation of pharmacologically inactive carbocisteine derivatives. Significant variability exists in metabolism due to genetic polymorphism in sulfoxidation capacity. Two cytosolic enzymes are responsible for the metabolism of carbocisteine: cysteine dioxygenase and phenylalanine 4-hydroxylase. Reduced metabolism can cause increased exposure to carbocisteine, explaining variable clinical response between patients who may polymorphisms affecting the enzymes responsible for carbocisteine metabolism. It is generally accepted that sulfodixation is the main metabolic pathway of carbocisteine, however, one group of researchers found a novel urinary metabolite, S-(carboxymethylthio)-L-cysteine (CMTC). No cysteinyl sulfoxide metabolites were found in the urine of patients taking carbocisteine in this study. |
| Route of elimination | About 30% to 60% of an orally administered dose is detected unchanged in the urine. |
| Volume of distribution | Carbocisteine penetrates well into the lung and bronchial secretions. |
| Clearance | Clearance information for carbocisteine is not readily available in the literature. |
Formulation & handling
- Carbocisteine is a small molecule API formulated exclusively for oral administration in multiple dose forms including syrups, solutions, tablets, and granules. The compound has high water solubility which facilitates formulation in aqueous media and oral liquids. It can be administered with or without food, indicating low sensitivity to food interactions in pharmacokinetics.
Regulatory status
Safety
| Toxicity | The oral LD50 of carbocisteine in rats is >15000 mg/kg. An overdose with carbocisteine is likely to result in gastrointestinal discomfort with nausea and vomiting. |
|---|
- Carbocisteine exhibits low acute oral toxicity, with an LD50 exceeding 15,000 mg/kg in rat models
- Exposure to excessive quantities may cause gastrointestinal irritation characterized by nausea and vomiting
- Appropriate handling measures should minimize ingestion and limit exposure to prevent inadvertent overdose
Carbocisteine is a type of Mucolytics
Mucolytics are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of respiratory conditions. Mucolytics are specifically designed to alleviate respiratory distress by enhancing the clearance of mucus from the airways.
These APIs work by breaking down the chemical bonds within mucus, reducing its viscosity and promoting its removal from the respiratory tract. By thinning the mucus, mucolytics facilitate easier expectoration and help to relieve congestion and cough associated with respiratory conditions such as chronic bronchitis, asthma, and cystic fibrosis.
One of the commonly used mucolytics is N-acetylcysteine (NAC), which acts as a precursor for the synthesis of glutathione—a powerful antioxidant. Glutathione helps to protect the respiratory system from oxidative stress and inflammation, promoting healthy lung function. NAC's mucolytic properties make it an effective treatment for conditions characterized by excessive mucus production.
Mucolytics can be formulated in various dosage forms, including oral tablets, effervescent granules, and inhalation solutions. The choice of formulation depends on the target condition and the desired mode of administration.
Overall, mucolytics play a crucial role in the management of respiratory disorders by improving mucus clearance and reducing airway obstruction. These pharmaceutical APIs offer relief to patients suffering from respiratory conditions, promoting better breathing and overall quality of life.
Carbocisteine (Mucolytics), classified under Respiratory Tract Agents
Respiratory Tract Agents are a vital category of pharmaceutical APIs (Active Pharmaceutical Ingredients) designed to treat respiratory conditions and diseases. These agents are specifically formulated to target the respiratory system, which includes the lungs, airways, and nasal passages. They play a crucial role in managing various respiratory disorders, such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
Respiratory Tract Agents encompass a wide range of medications, including bronchodilators, corticosteroids, antihistamines, and mucolytics. Bronchodilators are commonly used to relieve airway constriction and facilitate smooth breathing by relaxing the muscles in the airways. Corticosteroids help reduce inflammation in the respiratory system, alleviating symptoms and preventing exacerbations. Antihistamines work by blocking histamine receptors, thus mitigating allergic reactions that often impact the respiratory tract. Mucolytics aid in loosening and thinning mucus, making it easier to expel from the airways.
These APIs are developed through rigorous research and development processes, ensuring their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers rely on advanced technologies and stringent quality control measures to produce high-quality Respiratory Tract Agents. These APIs are subsequently incorporated into various dosage forms, including inhalers, nasal sprays, nebulizers, and oral medications.
Respiratory Tract Agents are essential in the management of respiratory conditions, providing relief from symptoms, improving lung function, and enhancing the overall quality of life for patients. They are prescribed by healthcare professionals and often used in combination therapies to achieve optimal results. As respiratory disorders continue to affect a significant portion of the global population, the development and availability of effective Respiratory Tract Agents play a vital role in addressing these health challenges and improving patient outcomes.
Carbocisteine API manufacturers & distributors
Compare qualified Carbocisteine API suppliers worldwide. We currently have 11 companies offering Carbocisteine API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| BCF | Producer | France | France | CEP, CoA, GMP | 1 products |
| DaeBong LS | Producer | South Korea | South Korea | CoA, JDMF | 1 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP | 58 products |
| Il Shin Chemical Co | Producer | South Korea | South Korea | CoA, JDMF | 3 products |
| Innovative Healthcare | Producer | India | India | CoA, GMP, HALAL, ISO9001, MSDS, WHO-GMP | 10 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF | 50 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Taenaka Kogyo | Producer | Japan | Japan | CoA, JDMF | 6 products |
| Wuhan Grand Hoyo | Producer | China | China | CEP, CoA, GMP | 2 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, MSDS, USDMF | 31 products |
When sending a request, specify which Carbocisteine 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 Carbocisteine 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.
