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Diflorasone | CAS No: 2557-49-5 | GMP-certified suppliers
A medication that provides potent anti-inflammatory and antipruritic relief for corticosteroid-responsive dermatoses in dermatological applications.
Therapeutic categories
Primary indications
- For relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses
Product Snapshot
- Diflorasone is available as topical creams and ointments
- It is primarily used for the relief of inflammatory and pruritic symptoms associated with corticosteroid-responsive dermatoses
- Diflorasone products are approved for use in the US and Canadian markets
Clinical Overview
Pharmacodynamically, diflorasone exhibits potent anti-inflammatory, antipruritic, and vasoconstrictive effects typical of topical corticosteroids. Upon dermal absorption, it undergoes pharmacokinetic processes analogous to those observed with systemic corticosteroids. Due to its potency, use with occlusive dressings is contraindicated. Clinical guidelines recommend limiting treatment duration to no more than two consecutive weeks and discontinuing therapy once adequate therapeutic outcomes are attained to reduce the risk of adverse effects.
The precise mechanism of action of diflorasone in mitigating inflammatory responses remains incompletely defined. It is generally accepted that the anti-inflammatory activity of topical corticosteroids involves induction of phospholipase A2-inhibitory proteins, collectively referred to as lipocortins. These proteins regulate the biosynthesis of pro-inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of arachidonic acid from membrane phospholipids, an initial step catalyzed by phospholipase A2.
From a safety perspective, diflorasone carries a profile consistent with potent corticosteroids, including potential local adverse effects such as skin atrophy, striae, and telangiectasia with prolonged use. Systemic absorption may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly when applied extensively or under occlusion, underscoring the importance of cautious dosing and monitoring.
Diflorasone is classified among potent (Group III) corticosteroids and is utilized in dermatological preparations globally. It is present in branded topical formulations designed for dermatologic indications requiring strong anti-inflammatory action.
For sourcing and quality assurance, procurement of diflorasone API should prioritize suppliers employing robust synthetic routes with validated impurity profiles. Compliance with pharmacopeial monographs or equivalent regulatory specifications ensures the API meets purity, potency, and stability criteria critical for formulation and regulatory approval processes.
Identification & chemistry
| Generic name | Diflorasone |
|---|---|
| Molecule type | Small molecule |
| CAS | 2557-49-5 |
| UNII | T2DHJ9645W |
| DrugBank ID | DB00223 |
Pharmacology
| Summary | Diflorasone is a potent topical corticosteroid that targets glucocorticoid receptors to exert anti-inflammatory, antipruritic, and vasoconstrictive effects. Its mechanism involves inducing lipocortins that inhibit phospholipase A2, reducing the release of arachidonic acid and subsequent synthesis of inflammatory mediators such as prostaglandins and leukotrienes. The drug is indicated for the relief of inflammation and pruritus in corticosteroid-responsive dermatoses. |
|---|---|
| Mechanism of action | The precise mechanism of the antiinflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A<sub>2</sub> 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 A<sub>2</sub>. |
| Pharmacodynamics | Like other topical corticosteroids, diflorasone has anti-inflammatory, antipruritic, and vasoconstrictive properties. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Diflorasone is a potent topical corticosteroid that should not be used with occlusive dressings. It is recommended that treatment should be limited to 2 consecutive weeks and therapy should be discontinued when adequate results have been achieved. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
ADME / PK
| Absorption | Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. |
|---|---|
| Protein binding | Bound to plasma proteins in varying degrees. |
| Metabolism | Metabolized, primarily in the liver, and then excreted by the kidneys. |
Formulation & handling
- Diflorasone is a small molecule corticosteroid intended for topical use only, not suitable for oral or injectable formulations.
- Due to low water solubility and moderate lipophilicity (LogP 1.34), formulation efforts should focus on appropriate excipients to enhance dermal absorption.
- As a steroid, it may require protection from light and oxidative conditions to maintain stability during storage and handling.
Regulatory status
| Lifecycle | The API is currently marketed in the US and Canada with key patents expiring between 2023 and 2025, indicating a transition toward increased generic competition and market maturity. Product availability is expected to expand as exclusivity periods conclude. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Diflorasone is produced by multiple manufacturers including Altana, Taro Pharmaceuticals, Pharmacia and Upjohn, and Sanofi Aventis, indicating a presence of several originator and established companies in its supply chain. Branded products such as ApexiCon and Diflorasone Diacetate are primarily marketed in the US and Canada. Patent expiration status suggests that generic competition is likely present or emerging in these markets. |
|---|
Safety
| Toxicity | Topically applied diflorasone can be absorbed in sufficient amounts to produce systemic effects. Symptoms of overdose include thinning of skin and suppression of adrenal cortex (decreased ability to respond to stress). |
|---|
- Diflorasone may be systemically absorbed through topical application, potentially leading to corticosteroid-related systemic effects
- Overexposure can result in dermal thinning and adrenal cortex suppression
- Appropriate handling measures should minimize dermal contact and prevent excessive exposure
Diflorasone 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.
Diflorasone (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.
Diflorasone API manufacturers & distributors
Compare qualified Diflorasone API suppliers worldwide. We currently have 3 companies offering Diflorasone 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP | 58 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
When sending a request, specify which Diflorasone 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 Diflorasone 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.
