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Clocortolone | CAS No: 4828-27-7 | GMP-certified suppliers
A medication that provides short-term topical relief of inflammation and itching in moderate to severe corticosteroid-responsive scalp dermatoses with moderate potency and favorable safety profile.
Therapeutic categories
Primary indications
- For short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp
Product Snapshot
- Clocortolone is available as a topical cream formulation for dermatological use
- It is primarily indicated for the short-term treatment of inflammatory and pruritic corticosteroid-responsive dermatoses of the scalp
- Clocortolone is approved for use in the US market
Clinical Overview
Pharmacologically, clocortolone exerts anti-inflammatory, antipruritic, and vasoconstrictive effects typical of corticosteroids. Its mechanism of action involves binding to intracellular glucocorticoid receptors, forming a complex that translocates to the cell nucleus. This complex modulates gene expression by promoting the synthesis of lipocortins—phospholipase A2 inhibitory proteins. Lipocortins reduce the release of arachidonic acid from membrane phospholipids, thus decreasing the production of pro-inflammatory mediators such as prostaglandins and leukotrienes. The exact pathways underlying its anti-inflammatory efficacy in steroid-responsive dermatoses remain incompletely elucidated but are consistent with class effects of topical corticosteroids.
Absorption of clocortolone through the skin allows engagement of systemic corticosteroid pharmacokinetic pathways; however, systemic exposure is typically minimal with recommended topical use. Treatment duration is generally limited to two consecutive weeks to minimize risks associated with corticosteroids, including skin atrophy, hypothalamic-pituitary-adrenal axis suppression, and other local or systemic adverse effects. Use under occlusive dressings is contraindicated due to increased absorption and potential toxicity.
Clocortolone is a fluorinated corticosteroid and is approved for clinical use in multiple regulatory jurisdictions. Its positioning as a moderately potent topical steroid makes it suitable for dermatological conditions demanding higher potency than mild corticosteroids but with a more favorable safety profile compared to high-potency alternatives.
For pharmaceutical development and API procurement, attention should be given to the quality and purity of clocortolone. Sourcing from manufacturers complying with current Good Manufacturing Practice (cGMP) and ensuring batch-to-batch consistency is critical due to the potency and safety considerations inherent to corticosteroid APIs. Impurities, including residual solvents or degradation products, must be rigorously controlled to meet pharmacopeial standards.
Identification & chemistry
| Generic name | Clocortolone |
|---|---|
| Molecule type | Small molecule |
| CAS | 4828-27-7 |
| UNII | N8ZUB7XE0H |
| DrugBank ID | DB00838 |
Pharmacology
| Summary | Clocortolone is a moderate potency topical corticosteroid that binds to the glucocorticoid receptor, modulating gene expression to induce production of lipocortins which inhibit phospholipase A2. This results in decreased release of arachidonic acid and subsequent reduction in pro-inflammatory mediators such as prostaglandins and leukotrienes. The drug exhibits anti-inflammatory, antipruritic, and vasoconstrictive effects, primarily used for short-term management of 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>. These enzyme transcriptional changes are mediated by the drug binding first to the glucocorticoid receptor. This complex can migrate to the cell nucleus which then binds to DNA initiating genetic activation and repression of various genes. |
| Pharmacodynamics | Like other topical corticosteroids, clocortolone has anti-inflammatory, antipruritic, and vasoconstrictive properties. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Clocortolone is a moderate potency 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. |
|---|---|
| Metabolism | Metabolized, primarily in the liver, and then excreted by the kidneys. |
Formulation & handling
- Clocortolone is a small molecule steroid intended for topical administration, not oral or injectable use.
- It exhibits low water solubility and moderate lipophilicity (LogP 2.47), which may influence formulation excipient selection.
- As a steroid with a hydroxyl group at the 21-position, handling precautions should consider potential sensitivity to light and air to maintain stability.
Regulatory status
| Lifecycle | The API is currently marketed in the US with patent protection recently expired, allowing for increased availability of generic formulations and a transition toward a mature market phase. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Clocortolone is primarily manufactured by a single originator company, Dow Pharmaceutical Sciences Inc., with packaging handled by multiple firms including Coria Laboratories, DPT Laboratories Ltd., and Valeant Ltd. Its branded products are predominantly marketed in the US, with no noted presence in the EU or other regions. The current patent status suggests that generic competition is likely established or imminent within this market. |
|---|
Safety
| Toxicity | Topically applied clocortolone 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). |
|---|
- Topical exposure may result in systemic absorption leading to adrenal cortex suppression
- Prolonged or excessive use can cause dermal thinning and related cutaneous effects
- Handle with appropriate protective equipment to minimize skin contact and potential systemic exposure
Clocortolone 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.
Clocortolone (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.
Clocortolone API manufacturers & distributors
Compare qualified Clocortolone API suppliers worldwide. We currently have 1 companies offering Clocortolone 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 |
|---|---|---|---|---|---|
| Farmabios | Producer | Italy | Italy | CoA, ISO9001, USDMF | 58 products |
When sending a request, specify which Clocortolone 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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