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Bromhexine | CAS No: 3572-43-8 | GMP-certified suppliers
A medication that reduces mucus viscosity and clears respiratory secretions to ease breathing in conditions like common cold, influenza, and respiratory tract infections.
Therapeutic categories
Primary indications
- Bromohexine is used alone or with other ingredients such as [diphenhydramine], [dextromethorphan], and [guaifenesin] to reduce mucus viscosity and clear mucus in conditions associated with mucus hypersecretion, including the common cold, influenza, respiratory tract infections, or other conditions
Product Snapshot
- Bromhexine is available in multiple formulations including oral tablets, capsules, syrups, injectable solutions for intramuscular and intravenous administration, suppositories, inhalation solutions, powders, and creams
- It is primarily used as a mucolytic agent to reduce mucus viscosity and facilitate mucus clearance in respiratory conditions characterized by mucus hypersecretion such as colds, influenza, and respiratory infections
- Bromhexine is approved for use in the US market
Clinical Overview
Pharmacologically, bromhexine reduces mucus viscosity, enhancing mucociliary transport, which is critical for maintaining lung function and defense mechanisms. Its mechanism of action involves both the thinning of secretions and stimulation of the ciliated epithelium in the respiratory tract to promote mucus clearance. Additionally, recent research highlights bromhexine’s inhibitory effect on the transmembrane serine protease 2 (TMPRSS2) receptor, a key facilitator of viral entry in infections such as influenza A, Middle East Respiratory Syndrome (MERS), and potentially SARS-CoV-2. The major active metabolite, ambroxol, has been shown in vitro to interact with the angiotensin-converting enzyme 2 (ACE2) receptor, potentially modulating viral binding and enhancing surfactant production, which may reduce alveolar vulnerability to viral invasion.
Regarding absorption, distribution, metabolism, and excretion (ADME), bromhexine is absorbed following oral administration and metabolized hepatically to active metabolites such as ambroxol. The compound is generally well tolerated; however, safety data emphasize considerations of hypersensitivity reactions and gastrointestinal disturbances. Toxicity profiles suggest a suitable margin of safety when used within therapeutic ranges.
Bromhexine is categorized pharmacologically among amines, aniline derivatives, and respiratory system agents and is approved for clinical use in multiple regions.
For formulation scientists, regulatory teams, and API sourcing managers, attention to purity standards, batch consistency, and compliance with pharmacopoeial specifications is essential. Quality control must address potential impurities, including related substances and residual solvents, to ensure safety, efficacy, and global regulatory acceptance of bromhexine APIs.
Identification & chemistry
| Generic name | Bromhexine |
|---|---|
| Molecule type | Small molecule |
| CAS | 3572-43-8 |
| UNII | Q1J152VB1P |
| DrugBank ID | DB09019 |
Pharmacology
| Summary | Bromhexine acts primarily by reducing mucus viscosity and enhancing mucociliary clearance in the respiratory tract, facilitating the expulsion of airway secretions. It inhibits transmembrane protease serine 2 (TMPRSS2) and may modulate angiotensin-converting enzyme 2 (ACE2) activity, mechanisms implicated in viral entry for respiratory pathogens such as influenza and SARS-CoV-2. These combined pharmacodynamic effects support its therapeutic use in conditions characterized by mucus hypersecretion and compromised airway clearance. |
|---|---|
| Mechanism of action | Inflammation of the airways, increased mucus secretion, and altered mucociliary clearance are the hallmarks of various diseases of the respiratory tract. Mucus clearance is necessary for lung health; bromhexine aids in mucus clearance by reducing the viscosity of mucus and activating the ciliary epithelium, allowing secretions to be expelled from the respiratory tract. Recent have studies have demonstrated that bromhexine inhibits the transmembrane serine protease 2 receptor (TMPRSS2) in humans. Activation of TMPRSS2 plays an important role in viral respiratory diseases such as influenza A and Middle East Respiratory Syndrome (MERS). Inhibition of receptor activation and viral entry by bromhexine may be effective in preventing or treating various respiratory illnesses, including COVID-19. In vitro studies have suggested the action of ambroxol (a metabolite of bromhexine) on the angiogensin-converting enzyme receptor 2 (ACE2), prevents entry of the viral envelope-anchored spike glycoprotein of SARS-Cov-2 into alveolar cells or increases the secretion of surfactant, preventing viral entry.[A233365 ,A233370] |
| Pharmacodynamics | Bromhexine thins airway secretions, improving breathing and discomfort associated with thick mucus in airways associated with a variety of respiratory conditions. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Transmembrane protease serine 2 | Humans | |
| Angiotensin-converting enzyme 2 | Humans | binder |
ADME / PK
| Absorption | After oral administration, bromhexine demonstrates linear pharmacokinetics when given in doses of 8-32 mg. Bromhexine is readily absorbed in the gastrointestinal tract at a rapid rate. This drug undergoes extensive first-pass effect in the range of 75-80%. The bioavailability is therefore reduced to approximately 22-27%. |
|---|---|
| Half-life | Following single oral doses ranging from 8 and 32 mg, the terminal half-life of bromhexine has been measured between 6.6 and 31.4 hours. |
| Protein binding | Bromhexine is approximately 95% bound to plasma proteins. |
| Metabolism | Bromhexine is almost completely metabolized to a variety of hydroxylated metabolites in addition to dibromanthranilic acid. Ambroxol is a known metabolite of bromhexine. In one study of human plasma, (E)-4-hydroxydemethylbromhexine (E-4-HDMB) and (E)-3-hydroxydemethylbromhexine (E-3-HDMB) were quantified as major metabolites of ambroxol, and (Z)-4-hydroxydemethylbromhexine and (Z)-3-hydroxydemethylbromhexine were quantified as minor metabolites. |
| Route of elimination | After a dose of bromhexine was administered during a pharmacokinetic study, approximately 97% of the radiolabeled dose was detected in the urine; under 1% was detected as the parent drug. |
| Volume of distribution | After intravenous administration in a pharmacokinetic study, bromhexine was found to be widely distributed. Bromhexine is known to cross the blood-brain barrier; small concentrations may cross the placenta. The average volume of distribution of bromhexine was 1209 ± 206 L (19 L/kg). Lung tissue concentrations of bromhexine two hours after a dose were 1.5 to 3.2 times higher in bronchial tissues than plasma concentrations. Pulmonary parynchema concentrations were 3.4 to 5.9 times higher when compared to plasma concentrations. |
| Clearance | The clearance of bromhexine ranges from 843-1073 mL/min, within the range of the hepatic circulation. |
Formulation & handling
- Bromhexine is a small molecule drug available for multiple administration routes including oral, injectable, inhalation, and rectal formulations.
- The compound exhibits low water solubility and moderate lipophilicity (LogP 4.42), which may impact formulation strategies for oral and parenteral dosage forms.
- Handling precautions should consider its solid state and potential impact on formulation stability across diverse delivery forms.
Regulatory status
| Lifecycle | The API's primary patent protection in the US recently expired, leading to an increase in generic product availability and a transition toward a mature market phase. Ongoing competition among manufacturers is expected to focus on cost and supply stability. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The bromhexine supply landscape features originator companies that have developed branded bromhexine hydrochloride products primarily targeting the US market. Branded versions are present with regulatory approval predominantly in the US, with limited visibility in other regions such as the EU. Patent expiries have likely allowed for existing generic competition in these markets. |
|---|
Safety
| Toxicity | The oral LD50 of bromhexine in rats is 6 g/kg. The observed symptoms of accidental overdose with bromhexine are consistent with the known adverse effects of bromhexine, including headache, nausea, and vomiting, among other symptoms. Provide symptomatic treatment and contact poison control services if an overdose is confirmed or suspected. |
|---|
- Bromhexine demonstrates low acute oral toxicity with an LD50 of 6 g/kg in rats
- Overdose may result in central nervous system and gastrointestinal effects including headache, nausea, and vomiting
- Handle with appropriate precautions to avoid accidental ingestion
Bromhexine 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.
Bromhexine (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.
Bromhexine API manufacturers & distributors
Compare qualified Bromhexine API suppliers worldwide. We currently have 6 companies offering Bromhexine API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Aarambh Life Science | Producer | India | India | CoA, GMP | 19 products |
| Bidachem | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 14 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 757 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Ven Petrochem & Pharma | Producer | India | India | CEP, CoA, WC | 3 products |
When sending a request, specify which Bromhexine 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 Bromhexine 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.
