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Cortisone acetate | CAS No: 50-04-4 | GMP-certified suppliers
A medication that provides anti-inflammatory and immunosuppressive effects to treat diverse endocrine, rheumatic, dermatologic, allergic, respiratory, hematologic, neoplastic, and gastrointestinal disorders.
Therapeutic categories
Primary indications
- Cortisone acetate is indicated to treat a wide variety of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, and gastrointestinal diseases and disorders
Product Snapshot
- Cortisone acetate is available as injectable and oral formulations, including injection, tablet, and suspension forms
- It is used for a broad range of therapeutic applications such as endocrine, rheumatic, allergic, respiratory, hematologic, neoplastic, and gastrointestinal conditions
- The product is approved and available in regulatory markets including the US and Canada
Clinical Overview
Pharmacologically, cortisone acetate acts through the glucocorticoid receptor, modulating gene expression to exert anti-inflammatory and immunosuppressive effects. It inhibits pro-inflammatory pathways by decreasing vasodilation and capillary permeability, reducing leukocyte migration, and suppressing inflammatory transcription factors such as NF-kappa B. Additionally, it promotes the expression of anti-inflammatory mediators including interleukin-10. At lower doses, it primarily serves as an anti-inflammatory agent, whereas higher doses confer immunosuppressive effects.
Key mechanisms include inhibition of phospholipase A2, resulting in decreased arachidonic acid derivatives, and modulation of neutrophil apoptosis and demargination. Prolonged high-dose therapy may engage mineralocorticoid receptors, affecting electrolyte balance by promoting sodium retention and potassium excretion.
Pharmacokinetic parameters show cortisone acetate has a moderate duration of action, typically supporting once-daily dosing regimens. It is metabolized by cytochrome P450 enzymes, notably CYP3A4 and CYP3A5, and can act as both substrate and inducer for these enzymes, with implications for drug-drug interactions. Corticosteroids such as cortisone acetate also interact with membrane transporters including P-glycoprotein and OAT3/SLC22A8.
Safety considerations include the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections due to immunosuppression. Monitoring and dose adjustments are critical to mitigate systemic corticosteroid adverse effects.
Notable brand formulations exist globally, often in oral or injectable forms.
For API sourcing, it is essential to ensure compliance with regulatory guidelines for glucocorticoid steroids, including robust analytical characterization, purity assessment, and control of potential impurities. Quality management should encompass stability profiling and verification of bioburden levels to meet pharmaceutical standards.
Identification & chemistry
| Generic name | Cortisone acetate |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-04-4 |
| UNII | 883WKN7W8X |
| DrugBank ID | DB01380 |
Pharmacology
| Summary | Cortisone acetate exerts its therapeutic effects primarily through glucocorticoid receptor activation, leading to modulation of gene expression that suppresses pro-inflammatory pathways and enhances anti-inflammatory responses. It reduces vasodilation, capillary permeability, and leukocyte migration while inhibiting key inflammatory mediators such as phospholipase A2 and NF-kappa B. These pharmacodynamic actions result in anti-inflammatory and immunosuppressive effects across multiple disease indications. |
|---|---|
| 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 neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote 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. The duration of action is moderate as it is generally given once 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 |
| Annexin A1 | Humans | inducer |
ADME / PK
| Protein binding | Corticosteroids are generally bound to corticosteroid binding globulin and serum albumin in plasma. |
|---|---|
| Route of elimination | Corticosteroids are eliminated predominantly in the urine. |
| Clearance | Data regarding the clearance of cortisone acetate is not readily available. |
Formulation & handling
- Cortisone acetate is a small molecule steroid available for both oral and intramuscular injectable administration.
- Low water solubility and moderate lipophilicity (LogP 2.1) suggest formulation considerations for dissolution and bioavailability.
- Administration with food is recommended to minimize gastrointestinal irritation during oral dosing.
Regulatory status
| Lifecycle | The API is approaching patent expiry in the US and Canada, leading to increased availability of generic versions and a shift towards a mature market with expanded treatment options. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for cortisone acetate involves multiple packagers serving primarily the US and Canadian markets. The presence of several branded products under the same name suggests established originator companies with a stable market presence in North America. Patent expiry has likely allowed for existing generic competition, as indicated by the variety of suppliers and packagers. |
|---|
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 hypertension, osteoporosis, metabolic disturbances, and immune suppression
- Prolonged use is associated with ocular complications such as cataract and glaucoma
- Handling guidelines should account for potential allergenic and dermatologic adverse effects, including dermal atrophy and acne
Cortisone acetate 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.
Cortisone acetate (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.
Cortisone acetate API manufacturers & distributors
Compare qualified Cortisone acetate API suppliers worldwide. We currently have 6 companies offering Cortisone acetate 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 |
|---|---|---|---|---|---|
| Henan Lihua | Producer | China | China | CoA, USDMF | 7 products |
| Jiangsu Jiaerke | Producer | China | China | CoA | 11 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Nanjing Bolka | Producer | China | China | CoA | 8 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, JDMF | 93 products |
| Tianjin Jinjin | Producer | China | China | CoA, GMP | 12 products |
When sending a request, specify which Cortisone acetate 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 Cortisone acetate 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.
