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Mometasone | CAS No: 105102-22-5 | GMP-certified suppliers
A medication that provides anti-inflammatory treatment for asthma maintenance and alleviates nasal symptoms of seasonal and perennial allergic rhinitis with minimal systemic exposure.
Therapeutic categories
Primary indications
- The inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy
- The nasal spray is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis
Product Snapshot
- Mometasone is available as topical creams, ointments, lotions, nasal sprays, respiratory inhalation powders, and solutions
- It is primarily used for maintenance treatment of asthma and for alleviating nasal symptoms associated with seasonal and perennial allergic rhinitis
- The compound is currently in experimental status without established approvals in major regulatory markets such as FDA or EMA
Clinical Overview
Clinically, mometasone furoate is formulated primarily as an inhaler and nasal spray. The inhaled form is indicated for the maintenance treatment of asthma, serving as prophylactic therapy to reduce inflammation and prevent exacerbations. The nasal spray formulation is utilized for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.
Pharmacodynamically, mometasone exhibits medium potency with anti-inflammatory, antipruritic, and vasoconstrictive effects. The compound exerts a strong local effect with minimal systemic exposure due to extensive first-pass hepatic metabolism and absence of active metabolites. On receptor binding, mometasone furoate demonstrates high affinity for the human glucocorticoid receptor, surpassing that of several corticosteroids such as dexamethasone and budesonide by multiple folds; however, the clinical relevance of this affinity has not been definitively established. Therapeutic effects in asthma patients typically manifest after one to two weeks of continuous use, indicative of a delayed onset common to inhaled corticosteroids.
The mechanism of action involves intracellular penetration of unbound corticosteroids, binding to cytoplasmic glucocorticoid receptors, which modulates gene expression to reduce inflammation. Key anti-inflammatory activities include inhibition of leukocyte enzyme release, diminished macrophage accumulation, reduced capillary permeability, and suppression of inflammatory mediators such as prostaglandins and leukotrienes through upregulation of lipocortins.
In terms of absorption, distribution, metabolism, and excretion (ADME), mometasone is characterized by low systemic bioavailability post-inhalation or intranasal administration, rapid hepatic metabolism predominantly via cytochrome P-450 enzymes CYP3A4 and CYP3A5, and elimination primarily through fecal excretion. Its effect profile is supported by interactions with cytochrome P-450 pathways, including CYP2C8 inhibition and CYP3A induction.
Safety considerations emphasize controlling exposure to minimize systemic corticosteroid effects. Though generally well-tolerated when used as prescribed, monitoring is necessary to avoid potential adverse reactions related to hypothalamic-pituitary-adrenal axis suppression, immunosuppression, or local adverse effects such as mucosal irritation.
Mometasone furoate is marketed in various formulations under multiple brand names worldwide, predominantly in respiratory and allergy management. For active pharmaceutical ingredient (API) procurement, attention should be given to stringent quality attributes including purity, polymorphic form, and compliance with pharmacopeial standards. Suppliers should provide comprehensive documentation covering synthetic route, impurity profiles, and stability data to ensure consistency and regulatory alignment for pharmaceutical development and manufacturing.
Identification & chemistry
| Generic name | Mometasone |
|---|---|
| Molecule type | Small molecule |
| CAS | 105102-22-5 |
| UNII | 8HR4QJ6DW8 |
| DrugBank ID | DB00764 |
Pharmacology
| Summary | Mometasone furoate is a synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects primarily through high-affinity binding to glucocorticoid receptors. Its mechanism involves inhibition of inflammatory mediator synthesis and reduction of leukocyte activity, capillary permeability, and histamine release. The compound is used for maintenance therapy in asthma and treatment of allergic rhinitis, with predominant local effects and extensive hepatic metabolism minimizing systemic exposure. |
|---|---|
| Mechanism of action | Unbound corticosteroids cross cell membranes and bind with high affinity to specific cytoplasmic receptors. Inflammation is decreased by diminishing the release of leukocytic acid hydrolases, prevention of macrophage accumulation at inflamed sites, interference with leukocyte adhesion to the capillary wall, reduction of capillary membrane permeability, reduction of complement components, inhibition of histamine and kinin release, and interference with the formation of scar tissue. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A<sub>2</sub> inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Mometasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. |
| Pharmacodynamics | Mometasone is a medium-potency synthetic corticosteroid with antiinflammatory, antipruritic, and vasoconstrictive properties. Studies in asthmatic patients have demonstrated that mometasone provides a favorable ratio of topical to systemic activity due to its primary local effect along with the extensive hepatic metabolism and the lack of active metabolites. Though effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer. Mometasone has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
| Progesterone receptor | Humans | agonist |
ADME / PK
| Absorption | Nasal spray is virtually undetectable in plasma |
|---|---|
| Half-life | 5.8 hours |
| Protein binding | 98% to 99% (in a concentration range of 5 to 500 ng/mL). |
| Metabolism | Hepatic. Extensive metabolism to multiple metabolites. There are no major metabolites detectable in plasma. Upon in vitro incubation, one of the minor metabolites formed is 6ß-hydroxy-mometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P-450 3A4. |
Formulation & handling
- Mometasone is a small molecule corticosteroid primarily formulated for topical, nasal, and respiratory inhalation routes rather than oral or injectable use.
- Due to its low aqueous solubility, formulations often utilize powders, suspensions, or creams/emulsions to enhance delivery and bioavailability.
- Handling should consider its steroid nature; moisture protection and avoidance of exposure to oxidizing environments are important for stability.
Regulatory status
| Lifecycle | The API's patent protections have expired or are nearing expiration in key markets such as the United States and Canada, indicating that the product is transitioning into a mature market phase with potential for generic competition. |
|---|
Supply Chain
| Supply chain summary | Mometasone is produced by a limited number of originator companies with established branded products across the US, EU, and other global markets. Patent expirations primarily occurred between 2011 and 2018, indicating that generic competition is currently present or emerging in various regions. The supply landscape reflects a transition from brand exclusivity to increased availability of generic formulations. |
|---|
Safety
| Toxicity | The potential for acute toxic effects following overdose with the mometasone inhaler is low. However, habitual overuse of the product can cause symptoms of steroid overload, including menstrual irregularities, acne, obesity, and muscle weakness. Single oral doses up to 8000 µg have been studied on human volunteers with no adverse events reported. |
|---|
- Chronic excessive exposure may lead to systemic corticosteroid effects such as adrenal suppression and metabolic disturbances
- Acute toxicity following overdose is low, with high single doses (up to 8000 µg) showing no reported adverse events in studies
- Handling should minimize inhalation and dermal absorption to avoid cumulative corticosteroid exposure
Mometasone is a type of Corticosteroids
Corticosteroids are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicine. These synthetic drugs mimic the effects of hormones naturally produced by the adrenal glands. Corticosteroids exhibit potent anti-inflammatory and immunosuppressive properties, making them widely used in the treatment of various medical conditions.
The main therapeutic applications of corticosteroids include the management of inflammatory disorders such as asthma, rheumatoid arthritis, and dermatological conditions like eczema and psoriasis. They are also employed in the treatment of allergic reactions, organ transplantations, and certain types of cancer.
Corticosteroids function by inhibiting the production of inflammatory mediators and suppressing immune responses. They act on specific receptors present in cells throughout the body, modulating gene expression and influencing various metabolic processes. These APIs are available in various formulations, including oral tablets, injectables, inhalers, nasal sprays, and topical creams.
It is crucial to note that corticosteroids must be prescribed and used under medical supervision due to their potential side effects, which can include adrenal suppression, osteoporosis, increased susceptibility to infections, and glucose intolerance. The dosage and duration of treatment vary depending on the condition being treated, and physicians carefully monitor patients to minimize any adverse effects.
In summary, corticosteroids are a vital class of pharmaceutical APIs with powerful anti-inflammatory and immunosuppressive properties. They are extensively used in the treatment of diverse medical conditions, providing relief to patients worldwide. However, their usage requires careful consideration and medical supervision to ensure optimal outcomes and minimize potential risks.
Mometasone (Corticosteroids), 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.
Mometasone API manufacturers & distributors
Compare qualified Mometasone API suppliers worldwide. We currently have 19 companies offering Mometasone API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | India | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cerata Pharmaceuticals LL... | Producer | India | India | CoA, FDA, GMP | 34 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Coral Drugs | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 25 products |
| Curia | Producer | United States | Spain | CEP, CoA, GMP, JDMF, MSDS, USDMF | 106 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Farmabios | Producer | Italy | Italy | CEP, CoA, FDA, GMP, ISO9001, USDMF | 58 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Great Pacific Exports | Producer | India | India | CoA, WC | 7 products |
| Hovione Farmaciencia | Producer | Portugal | Portugal | CEP, CoA, FDA, GMP, JDMF, USDMF | 16 products |
| Hunan Yuxin Pharmaceutica... | Producer | China | China | CoA, USDMF | 14 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Miat | Producer | Italy | Italy | CoA | 10 products |
| Sicor De México | Producer | Mexico | Mexico | CoA, JDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 764 products |
| Symbiotec Pharma | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 50 products |
| Tianjin Tianyao | Producer | China | China | CoA, USDMF | 24 products |
| Vamsi Labs | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 29 products |
When sending a request, specify which Mometasone 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 Mometasone 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.
