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Dexbrompheniramine | CAS No: 132-21-8 | GMP-certified suppliers
A medication that provides symptomatic relief from allergies, hay fever, and common cold symptoms by targeting histamine H1 receptors for systemic antihistamine effects.
Therapeutic categories
Primary indications
- For treatment and relief of symptoms of allergies, hay fever, and colds
Product Snapshot
- Dexbrompheniramine is available as oral small molecule formulations including solution, tablets (regular and extended release), syrup, and chewable tablets
- It is primarily used for symptomatic treatment of allergies, hay fever, and common cold symptoms
- The product is approved for commercial use in the US and Canadian pharmaceutical markets
Clinical Overview
The pharmacologic action of dexbrompheniramine is mediated through competitive antagonism at histamine H1 receptors. In allergic reactions, allergen-triggered cross-linking of IgE antibodies on mast cells and basophils leads to the release of histamine. Histamine subsequently interacts with H1 receptors distributed on effector cells within the respiratory tract, blood vessels, and gastrointestinal tract. This interaction precipitates symptoms such as pruritus, vasodilation, bronchoconstriction, and increased vascular permeability. By binding to the H1 receptor sites, dexbrompheniramine inhibits endogenous histamine effects, providing temporary symptom relief including reduction of sneezing, nasal congestion, and ocular irritation.
Pharmacokinetic and ADME parameters for dexbrompheniramine indicate oral bioavailability suitable for systemic action. It undergoes hepatic metabolism, with elimination pathways involving renal excretion of metabolites. Specific data on half-life and metabolic enzymes are not included here but should be referenced in detailed regulatory dossiers.
Safety considerations include potential central nervous system depressant effects, consistent with its classification among substituted alkylamines. Additionally, the agent is listed among potential QTc-prolonging compounds, warranting cautious use in patients predisposed to cardiac arrhythmias. Common adverse effects may include sedation, dry mouth, and gastrointestinal discomfort.
Dexbrompheniramine has been incorporated into various pharmaceutical formulations globally, often in combination with other agents for upper respiratory allergy symptom management.
From an API sourcing and quality perspective, procurement should ensure compliance with pharmacopeial standards for purity, impurity profiles, and residual solvents. Validation of manufacturing processes, control of chiral purity, and adherence to Good Manufacturing Practices (GMP) are critical to maintain consistent quality and regulatory acceptance in global markets.
Identification & chemistry
| Generic name | Dexbrompheniramine |
|---|---|
| Molecule type | Small molecule |
| CAS | 132-21-8 |
| UNII | 75T64B71RP |
| DrugBank ID | DB00405 |
Pharmacology
| Summary | Dexbrompheniramine is a selective antagonist of histamine H1 receptors, competitively inhibiting histamine binding on effector cells in the gastrointestinal tract, vasculature, and respiratory system. By blocking H1 receptor activation, it mitigates histamine-induced effects such as vasodilation, increased vascular permeability, and bronchoconstriction associated with allergic responses. This mechanism underlies its use in managing symptoms related to allergic rhinitis and other upper respiratory allergies. |
|---|---|
| Mechanism of action | Dexbrompheniramine competitively binds to the histamine H<sub>1</sub>-receptor. It competes with histamine for the normal H<sub>1</sub>-receptor sites on effector cells of the gastrointestinal tract, blood vessels and respiratory tract. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. |
| Pharmacodynamics | In allergic reactions an allergen interacts with and cross-links surface IgE antibodies on mast cells and basophils. Once the mast cell-antibody-antigen complex is formed, a complex series of events occurs that eventually leads to cell-degranulation and the release of histamine (and other chemical mediators) from the mast cell or basophil. Once released, histamine can react with local or widespread tissues through histamine receptors. Histamine, acting on H<sub>1</sub>-receptors, produces pruritis, vasodilatation, hypotension, flushing, headache, tachycardia, and bronchoconstriction. Histamine also increases vascular permeability and potentiates pain. Dexbrompheniramine is a histamine H1 antagonist (or more correctly, an inverse histamine agonist) of the alkylamine class. It provides effective, temporary relief of sneezing, watery and itchy eyes, and runny nose due to hay fever and other upper respiratory allergies. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histamine H1 receptor | Humans | antagonist |
ADME / PK
| Absorption | Antihistamines are well absorbed from the gastrointestinal tract after oral administration. |
|---|---|
| Half-life | 25 hours |
| Metabolism | Hepatic (cytochrome P-450 system), some renal. |
Formulation & handling
- Dexbrompheniramine is a small molecule API formulated exclusively for oral administration in various dosage forms including tablets, extended-release tablets, syrups, and solutions.
- The compound exhibits low water solubility and moderate lipophilicity (LogP 3.75), which should be considered in formulation strategies for bioavailability optimization.
- Alcohol consumption should be avoided during treatment as it may potentiate central nervous system depression and increased drowsiness.
Regulatory status
| Lifecycle | The API is currently marketed in the US and Canada, with key patents expiring within the next two years, indicating a transition toward increased generic competition and a more mature market phase. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dexbrompheniramine is primarily manufactured by Schering Corp, with packaging handled by Poly Pharmaceuticals Inc. The branded products are distributed mainly in the US and Canadian markets. Patent expiry or exclusivity status is not explicitly provided, but the presence of multiple brand variants may indicate existing generic competition. |
|---|
Safety
| Toxicity | Signs of an overdose include fast or irregular heartbeat, mental or mood changes, tightness in the chest, and unusual tiredness or weakness. |
|---|
- Overdose may cause cardiovascular and central nervous system effects, including arrhythmia and altered mental status
- Potential for respiratory distress characterized by chest tightness
- Monitor for signs of unusual fatigue or weakness during handling and formulation processes
Dexbrompheniramine is a type of Antihistamines
Antihistamines are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the treatment of allergies and allergic reactions. These compounds work by blocking the action of histamines, which are responsible for triggering allergic symptoms such as itching, sneezing, runny nose, and watery eyes.
Antihistamines can be classified into two main categories: first-generation and second-generation antihistamines. First-generation antihistamines, such as diphenhydramine and chlorpheniramine, have been in use for several decades. They are effective in relieving allergy symptoms but are associated with drowsiness and other side effects due to their ability to cross the blood-brain barrier.
On the other hand, second-generation antihistamines, including cetirizine, loratadine, and fexofenadine, offer similar allergy relief with fewer sedative effects. These newer antihistamines are preferred for their improved safety profiles, making them suitable for use during the day without causing significant drowsiness.
Antihistamines are available in various forms, including tablets, capsules, syrups, and topical creams. They are extensively used to manage conditions such as hay fever, hives, allergic rhinitis, and insect bites. Moreover, antihistamines may also be combined with decongestants or other medications to provide relief from nasal congestion and sinus symptoms.
As pharmaceutical APIs, antihistamines are produced through meticulous synthesis and manufacturing processes, adhering to strict quality standards. These APIs serve as the active components in various branded and generic pharmaceutical formulations, making them crucial in the pharmaceutical industry's production of allergy medications.
In conclusion, antihistamines are a significant subcategory of pharmaceutical APIs widely used for alleviating allergy symptoms. Their classification into first- and second-generation antihistamines offers options based on efficacy and sedative effects. By blocking histamines, antihistamines provide relief from common allergic reactions, making them essential in the development of effective allergy medications.
Dexbrompheniramine (Antihistamines), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Dexbrompheniramine API manufacturers & distributors
Compare qualified Dexbrompheniramine API suppliers worldwide. We currently have 1 companies offering Dexbrompheniramine API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Keshava Organics | Producer | India | India | CoA, WC | 6 products |
When sending a request, specify which Dexbrompheniramine 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.).
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