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Ulobetasol | CAS No: 98651-66-2 | GMP-certified suppliers
A medication that provides potent anti-inflammatory and immunosuppressive effects for treating severe plaque psoriasis and corticosteroid-responsive inflammatory dermatoses.
Therapeutic categories
Primary indications
- Ulobetasol cream and ointment are indicated in the treatment of inflammatory and pruritic corticosteroid responsive dermatoses
- Ulobetasol lotion is indicated in the treatment of plaque psoriasis
Product Snapshot
- Ulobetasol is available as topical formulations including cream, ointment, lotion, aerosol, and foam
- It is primarily used for the treatment of corticosteroid-responsive inflammatory dermatoses and plaque psoriasis
- The product is approved for use in the US and Canadian markets
Clinical Overview
Pharmacologically, ulobetasol belongs to the class of glucocorticoids characterized by a hydroxylated prostane-based steroid structure. It exerts its effects by binding to intracellular glucocorticoid receptors, leading to modulation of gene expression. This binding results in decreased vasodilation and capillary permeability, reduced leukocyte migration, and inhibition of pro-inflammatory transcription factors such as NF-kappa B. The compound also promotes anti-inflammatory mediators including interleukin-10 and inhibits phospholipase A2 activity, thereby reducing the production of arachidonic acid derivatives. The overall effect is robust anti-inflammatory and immunosuppressive activity, with dose-dependent immunosuppression occurring at higher concentrations.
Ulobetasol demonstrates a moderate duration of action, generally requiring once or twice daily application. As a corticosteroid, it carries the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use or application over large body surface areas. Additional safety considerations include increased susceptibility to infections due to immunosuppression, potential for local skin atrophy, and mineralocorticoid-related electrolyte imbalances at high systemic exposure.
The compound received FDA approval on December 17, 1990, and is classified under multiple therapeutic categories including adrenal cortex hormones, anti-inflammatory agents, and potent topical corticosteroids (Group III). It is structurally related to clobetasol, another potent corticosteroid.
For pharmaceutical development and regulatory purposes, sourcing of ulobetasol API requires attention to strict quality controls to ensure purity, absence of contaminants, and batch-to-batch consistency. Suppliers should provide full compliance documentation per international regulatory standards, including certificates of analysis, impurity profiles, and stability data to facilitate secure incorporation into topical dermatological formulations.
Identification & chemistry
| Generic name | Ulobetasol |
|---|---|
| Molecule type | Small molecule |
| CAS | 98651-66-2 |
| UNII | 9P6159HM7T |
| DrugBank ID | DB00596 |
Pharmacology
| Summary | Ulobetasol acts as a potent glucocorticoid receptor agonist, modulating gene expression to suppress pro-inflammatory pathways and enhance anti-inflammatory responses. It reduces vasodilation, capillary permeability, and leukocyte migration, thereby decreasing inflammation and immune activity. The pharmacodynamic profile includes inhibition of phospholipase A2, suppression of NF-kappa B, and promotion of anti-inflammatory cytokines such as interleukin-10. |
|---|---|
| Mechanism of action | The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit phospholipase 2 and neutrophil apoptosis and demargination, resulting in decreased formation of arachidonic acid derivatives. They also inhibit NF-Kappa B and other inflammatory transcription factors while promoting anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels. |
| Pharmacodynamics | Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Ulobetasol has a moderate duration of action as it is applied once or twice daily. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
ADME / PK
| Absorption | Ulobetasol lotion reaches a C<sub>max</sub> of 201.1 ± 157.5 pg/mL, with a T<sub>max</sub> of 3 hours, and an AUC of 1632 ± 1147 pg\*h/mL. Absorption can be influenced by skin integrity, the vehicle used, inflammation, or disease processes. |
|---|---|
| Half-life | _In vitro_ experiments show halobetasol propionate, a derivative of ulobetasol, has a half life of 33 minutes. |
| Protein binding | Ulobetasol is likely bound to corticosteroid binding globulin in serum. |
| Route of elimination | Corticosteroids are eliminated predominantly in the urine. |
Formulation & handling
- Ulobetasol is formulated exclusively for topical and cutaneous application, not for oral or injectable routes.
- As a small molecule steroid, it has low water solubility and moderate lipophilicity (LogP 2.7), influencing formulation vehicle selection.
- Careful handling to avoid systemic exposure is recommended due to potent corticosteroid activity, with no noted food sensitivity interactions.
Regulatory status
| Lifecycle | The API is protected by multiple patents in the United States with expiration dates ranging from 2020 to 2036. It is marketed in the US and Canada, indicating an established presence with ongoing patent coverage sustaining market exclusivity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Ulobetasol includes multiple originator companies engaged in both production and packaging, indicating a diversified supply base primarily focused on the US and Canadian markets. Branded products such as Bryhali and Duobrii have a strong presence in North America. Several key patents remain active through the early to mid-2030s, suggesting that generic competition may be limited or forthcoming only after these patent expirations. |
|---|
Safety
| Toxicity | Data regarding acute overdoses of glucocorticoids are rare. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency. Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment. |
|---|
- Chronic exposure to high doses may cause systemic effects including immune suppression, metabolic disturbances, and musculoskeletal abnormalities
- Potential adverse effects include dermal atrophy and hypersensitivity reactions upon topical application
- Handling protocols should minimize exposure and employ appropriate protective measures to prevent systemic absorption
Ulobetasol 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.
Ulobetasol (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.
Ulobetasol API manufacturers & distributors
Compare qualified Ulobetasol API suppliers worldwide. We currently have 3 companies offering Ulobetasol API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hovione Farmaciencia | Producer | Portugal | Portugal | CoA, USDMF | 16 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
When sending a request, specify which Ulobetasol 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 Ulobetasol 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.
