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Fluticasone propionate | CAS No: 80474-14-2 | GMP-certified suppliers
A medication that supports asthma prophylaxis, relieves symptoms of allergic and nonallergic rhinitis, and manages inflammatory or pruritic dermatoses across common therapeutic formulations.
Therapeutic categories
Primary indications
- Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxis[FDA Label]as well as inflammatory and pruritic dermatoses
- Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis
Product Snapshot
- Fluticasone propionate is supplied as inhalation powders and aerosols, nasal sprays, and topical creams/ointments for corticosteroid delivery
- It is used for asthma prophylaxis, management of allergic and nonallergic rhinitis, and treatment of inflammatory dermatoses
- It is approved in the US, Canada, and the EU
Clinical Overview
Its pharmacological activity arises from high-affinity activation of glucocorticoid receptors. In preclinical models, receptor engagement suppresses inflammatory cell recruitment, including inhibition of lung eosinophilia. In topical applications, the compound also produces cutaneous vasoconstriction, consistent with potent local glucocorticoid effects. Although the full mechanism is not fully delineated, downstream modulation of inflammatory mediators and immune cell function is central to its therapeutic profile.
Fluticasone propionate exhibits minimal systemic exposure when administered intranasally or by inhalation due to extensive first-pass metabolism and low oral bioavailability. It is primarily metabolized by CYP3A4, and it is classified as both a CYP3A substrate and an inhibitor across several CYP3A isoforms. Systemic accumulation can increase when co-administered with strong CYP3A inhibitors, and this interaction warrants clinical caution. Distribution is characterized by high plasma protein binding. Elimination is predominantly via hepatic metabolism with excretion of metabolites in feces.
Safety considerations include potential hypothalamic-pituitary-adrenal axis suppression with excessive systemic absorption, particularly with high-dose inhaled or extensive topical use. Local adverse effects vary by route and may include oral candidiasis with inhaled use, nasal irritation with intranasal formulations, and skin atrophy with prolonged topical exposure.
Common usage contexts include inhaled products for chronic asthma management and nasal sprays widely employed for seasonal or perennial rhinitis. Topical forms are used in dermatology for short-term control of inflammatory dermatoses.
For API procurement, suppliers should ensure control of particle size distribution, polymorphic form, and residual solvent levels, along with verification of identity and potency consistent with major pharmacopeial standards to support reliable formulation performance.
Identification & chemistry
| Generic name | Fluticasone propionate |
|---|---|
| Molecule type | Small molecule |
| CAS | 80474-14-2 |
| UNII | O2GMZ0LF5W |
| DrugBank ID | DB00588 |
Pharmacology
| Summary | Fluticasone propionate is a synthetic corticosteroid that activates glucocorticoid receptors to modulate inflammatory signaling and reduce activity of inflammatory cells and mediators. Its pharmacodynamic effects include suppression of eosinophilic inflammation and, in topical use, cutaneous vasoconstriction. The drug also interacts with progesterone and mineralocorticoid receptors and cytosolic phospholipase A2, contributing to its broader anti‑inflammatory profile. |
|---|---|
| Mechanism of action | Fluticasone propionate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. Fluticasone propionate activates glucocorticoid receptors and inhibits lung eosinophilia in rats. |
| Pharmacodynamics | Systemically, fluticasone propionate activates glucocorticoid receptors, and inhibits lung eosinophilia in rats[FDA Label]. Fluticasone propionate as a topical formulation is also associated with vasoconstriction in the skin. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
| Progesterone receptor | Humans | agonist |
| Cytosolic phospholipase A2 | Humans | inhibitor |
ADME / PK
| Absorption | Intranasal bioavailability of fluticasone propionate is <2%, and oral bioavailability is <1%[FDA Label]. Intranasal exposure results in the majority of the dose being swallowed. Topical absorption of fluticasone propionate is very low but can change depending on a number of factors including integrity of the skin and the presence of inflammation or disease. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 9.0%. |
|---|---|
| Half-life | 7.8 hours for intravenous fluticasone propionate[FDA Label]. A study of 24 healthy Caucasian males shows a half life of 14.0 hours following intravenous administration and 10.8 hours following inhalation. |
| Protein binding | Fluticasone propionate is 99% protein bound in serum. Topical fluticasone propionate is only 91% protein bound in serum however. |
| Metabolism | Fluticasone propionate is cleared from hepatic metabolism by cytochrome P450 3A4[FDA Label]. Fluticasone propionate is hydrolysed at the FIVE-S-fluoromethyl carbothioate group, forming an inactive metabolite[FDA Label]. |
| Route of elimination | Fluticasone propionate is mainly eliminated in the feces with <5% eliminated in the urine[FDA Label]. |
| Volume of distribution | The volume of distribution of intravenous fluticasone propionate is 4.2L/kg[FDA Label]. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 577L following intravenous administration. |
| Clearance | 1093mL/min for fluticasone propionate. A study of 24 healthy Caucasian males showed a clearance of 63.9L/h following intravenous administration. |
Formulation & handling
- Fluticasone propionate is a lipophilic, poorly water‑soluble steroid ester typically formulated as inhalation or nasal suspensions or dry powders, requiring appropriate particle-size control for airway deposition.
- The solid API is chemically stable but needs protection from moisture and oxidation, with suspensions relying on robust physical stability and suitable surfactants to prevent aggregation or settling.
- Topical and intranasal formulations commonly use semi-solid or aqueous-suspension systems where solubility limits necessitate dispersed-phase designs rather than true solutions.
Regulatory status
| Lifecycle | The API is in a mature phase, with key US patents expiring between 2010 and 2017 and the final Canadian patent expiring in 2020. Across the US, Canada, and EU markets, these expirations indicate established generic availability and a late‑lifecycle competitive landscape. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Fluticasone propionate was originally developed by an originator group within GlaxoSmithKline, but the current supply landscape includes numerous additional manufacturers and packagers, reflecting a broad generic production base. Branded and generic products are established across the US, Canada, and the EU. Patent expiries in these regions indicate that generic competition is already well‑established and continues to expand globally. |
|---|
Safety
| Toxicity | Fluticasone propionate's use in specific populations has not been well studied. Fluticasone propionate is not carcinogenic, mutagenic, or clastogenic, nor did it affect fertility in animal studies[FDA Label]. Subcutaneous fluticasone propionate has been shown to produce teratogenic effects in rats though oral administration does not[FDA Label]. Generally, there are no reported adverse effects with fluticasone in pregnancy. Fluticasone propionate in human milk may cause growth suppression, effects on endogenous corticosteroid production, or other effects. Pediatric patients treated with fluticasone propionate ointment experienced adrenal suppression. Geriatric patients treated with fluticasone propionate did not show any difference in safety or efficacy compared to other patient groups, though older patients may be more sensitive to adverse effects. There is no difference in the clearance of fluticasone propionate across genders or race[FDA Label]. Patients with hepatic impairment should be closely monitored due to the elimination mechanism[FDA Label]. |
|---|
- Subcutaneous exposure has produced teratogenic effects in rats, while oral routes did not, indicating route‑dependent developmental toxicity
- Pediatric use has been associated with adrenal suppression, and fluticasone detected in human milk may influence infant growth or endogenous corticosteroid activity
- Hepatic impairment can alter systemic clearance due to metabolism‑dependent elimination pathways, warranting attention to exposure levels in this population
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Fluticasone Propionate 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.
Fluticasone Propionate (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.
Fluticasone Propionate API manufacturers & distributors
Compare qualified Fluticasone Propionate API suppliers worldwide. We currently have 23 companies offering Fluticasone Propionate API, with manufacturing taking place in 12 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 |
|---|---|---|---|---|---|
| Aesica Pharma | Producer | United Kingdom | United Kingdom | CoA, GMP | 5 products |
| Alps Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 8 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Cipla | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Coral Drugs | Producer | India | India | CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 25 products |
| Curia | Producer | United States | Spain | CEP, CoA, GMP, MSDS | 106 products |
| Farmabios | Producer | Italy | Italy | CEP, CoA, FDA, GMP, ISO9001, USDMF | 58 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CoA, GMP, USDMF | 19 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hovione Farmaciencia | Producer | Portugal | Portugal | CEP, CoA, FDA, GMP, JDMF, USDMF | 16 products |
| Industriale Chimica | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, USDMF | 33 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Miat | Producer | Italy | Italy | CoA | 10 products |
| Mylan | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor De México | Producer | Mexico | Mexico | CoA, JDMF | 11 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, WC | 219 products |
| Vamsi Labs | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, USDMF, WHO-GMP | 29 products |
When sending a request, specify which Fluticasone Propionate 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 Fluticasone Propionate 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.
Frequently asked questions about Fluticasone Propionate API
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Regulatory
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