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Fluorometholone | CAS No: 426-13-1 | GMP-certified suppliers
A medication that treats corticosteroid-responsive inflammation and allergic conditions of the eye’s conjunctiva, cornea, and anterior segment to reduce ocular inflammation and tissue damage.
Therapeutic categories
Primary indications
- For the ophthalmic treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe
Product Snapshot
- Fluorometholone is available primarily as ophthalmic suspensions, solutions/drops, and ointments for topical application
- It is used in the treatment of corticosteroid-responsive inflammation affecting the conjunctiva, cornea, and anterior segment of the eye
- The product is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, fluorometholone is classified within the group of gluco/mineralocorticoids, steroids characterized by a hydroxylated prostane backbone. Its anti-inflammatory effects result from modulation of multiple cellular processes associated with inflammation. These include the inhibition of edema formation, fibrin deposition, capillary dilation and proliferation, leukocyte migration, fibroblast proliferation, collagen deposition, and scar formation. Such actions contribute to a reduction in inflammatory tissue damage but may also delay tissue healing.
The underlying mechanism of action involves interaction with cytosolic glucocorticoid receptors. Upon binding, the receptor–ligand complex translocates into the nucleus, where it binds specific glucocorticoid response elements (GRE) in target gene promoters. This binding modifies gene transcription, notably upregulating lipocortins—phospholipase A2 inhibitory proteins that suppress the release of arachidonic acid from membrane phospholipids. Since arachidonic acid is a precursor for pro-inflammatory mediators such as prostaglandins and leukotrienes, this results in a decrease in their synthesis.
Key pharmacokinetic data related to absorption, distribution, metabolism, and excretion (ADME) of fluorometholone are limited in the public domain, though it is known to undergo metabolism partially mediated by cytochrome P450 enzymes, including CYP3A isoforms. Careful consideration of potential enzyme interactions is warranted during co-administration with other substrates, inducers, or inhibitors of these enzymes.
Safety considerations include the risk of corticosteroid-associated ocular adverse effects such as increased intraocular pressure, glaucoma, cataract formation, and potential delayed wound healing. Systemic absorption is generally low with topical ocular administration, but monitoring remains advisable during prolonged therapy.
Fluorometholone is marketed globally under various formulations primarily as ophthalmic suspensions. Regulatory approval status varies by region, with formulations approved for ophthalmic use and investigational topical dermatological applications.
When sourcing fluorometholone API, adherence to pharmacopeial standards and regulatory requirements is crucial. Quality attributes to consider include purity, potency, residual solvents, and absence of microbial contamination. Reliable suppliers should provide comprehensive certificates of analysis and demonstrate compliance with good manufacturing practices (GMP) to ensure consistency and suitability for pharmaceutical formulation.
Identification & chemistry
| Generic name | Fluorometholone |
|---|---|
| Molecule type | Small molecule |
| CAS | 426-13-1 |
| UNII | SV0CSG527L |
| DrugBank ID | DB00324 |
Pharmacology
| Summary | Fluorometholone is an ocular corticosteroid that exerts its effect primarily through activation of the cytosolic glucocorticoid receptor. The receptor-ligand complex modulates gene expression by binding to glucocorticoid response elements, leading to the induction of lipocortins which inhibit phospholipase A2 activity. This mechanism reduces the biosynthesis of inflammatory mediators like prostaglandins and leukotrienes, resulting in decreased inflammation and associated tissue responses in ocular tissues. |
|---|---|
| Mechanism of action | There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Their primary target is the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. |
| Pharmacodynamics | Corticosteroids such as fluorometholone inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
Formulation & handling
- Fluorometholone is a small molecule corticosteroid primarily formulated for ophthalmic use as solutions, suspensions, and ointments.
- Its low water solubility and moderate LogP suggest formulation challenges in achieving stable aqueous ophthalmic suspensions or solutions.
- As an ophthalmic drug, it requires sterile handling and packaging to maintain stability and prevent microbial contamination.
Regulatory status
| Lifecycle | The API's primary patent protection in the US and Canada has expired, allowing for generic competition in these markets. As a result, the product is in the mature phase of its lifecycle with established market presence. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Fluorometholone includes multiple originator companies such as Pharmacia and Upjohn, Allergan, Novartis, and Alcon Laboratories. Branded products are primarily present in the US and Canadian markets under names like Flarex and Fluor-Op. The absence of explicit patent expiration data suggests that generic competition may already exist or is feasible given the presence of several packagers supplying similar formulations. |
|---|
Safety
| Toxicity | Side effects may include acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. LD<sub>50</sub> = 234 mg/kg (rats) |
|---|
- May cause ocular toxicity including acute anterior uveitis and globe perforation upon exposure
- Local administration has been associated with keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, accommodation loss, and ptosis
- Oral LD50 in rats is 234 mg/kg, indicating moderate systemic toxicity risk on accidental ingestion
Fluorometholone 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.
Fluorometholone (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.
Fluorometholone API manufacturers & distributors
Compare qualified Fluorometholone API suppliers worldwide. We currently have 7 companies offering Fluorometholone API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Curia | Producer | United States | Spain | CoA, GMP, MSDS, USDMF | 106 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, JDMF, USDMF | 93 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | CoA, GMP | 66 products |
When sending a request, specify which Fluorometholone 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 Fluorometholone 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.
