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Methylprednisolone | CAS No: 83-43-2 | GMP-certified suppliers
A medication that provides anti-inflammatory and immunosuppressive effects for treating endocrine, rheumatic, dermatologic, allergic, respiratory, and autoimmune disorders.
Therapeutic categories
Primary indications
- Oral and intramuscular methylprednisolone are indicated for a number of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, nervous system, and other disorders
- Intra-articular and soft tissue injections are indicated for short term treatment of acute gouty arthritis, acute and subactute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis
- Intralesional injections are indicated for alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus and psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic infiltrated inflammatory lesions of granuloma annulare
Product Snapshot
- Methylprednisolone is available in multiple formulation types including oral tablets, topical creams and ointments, as well as injectable powders and suspensions suitable for intramuscular, intravenous, intra-articular, and intralesional routes
- It is primarily utilized for a broad range of indications spanning endocrine, rheumatic, dermatologic, allergic, respiratory, hematologic, neoplastic, gastrointestinal, and neurological disorders, including acute inflammatory and autoimmune conditions
- The product holds regulatory approval in the United States and Canada for both human and veterinary use
Clinical Overview
Clinically, methylprednisolone is administered via oral and intramuscular routes for diverse indications including endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and nervous system disorders. It is also utilized via intra-articular and soft tissue injections for short-term management of acute gouty arthritis, bursitis, tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis associated with osteoarthritis. Intralesional injections target conditions such as alopecia areata, discoid lupus erythematosus, keloids, lichen planus, psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized inflammatory lesions like granuloma annulare.
Pharmacodynamically, methylprednisolone acts by binding to the glucocorticoid receptor, modulating gene expression to suppress pro-inflammatory pathways and enhance anti-inflammatory responses. This includes inhibition of phospholipase A2, suppression of NF-kappa B and other transcription factors, and increased production of anti-inflammatory cytokines such as interleukin-10. Its short-term effects reduce capillary permeability and leukocyte migration. Dosage determines effects ranging from anti-inflammatory at lower levels to immunosuppression at higher doses. Prolonged high-dose administration may activate mineralocorticoid receptors, leading to electrolyte disturbances including sodium retention and potassium loss.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics reflect corticosteroid pharmacokinetics, with metabolism primarily via cytochrome P450 enzymes and potential induction of multiple CYP isoforms. Safety considerations include the risk of hypothalamic-pituitary-adrenal axis suppression, increased infection susceptibility, and electrolyte imbalances. Patient monitoring is advised during prolonged therapy or high-dose regimens.
Notable usage contexts include investigational applications in COVID-19-related pneumonia management, reflecting ongoing clinical evaluations of efficacy and safety in viral inflammatory conditions.
From an API procurement standpoint, quality attributes such as purity, polymorphic form, residual solvents, and stability are critical given methylprednisolone’s sensitivity to manufacturing variations. Compliance with pharmacopeial standards (e.g., USP, EP) and adherence to Good Manufacturing Practices (GMP) ensure suitability for pharmaceutical formulations. Supplier qualification should assess batch-to-batch consistency, impurity profiles, and supply chain robustness to support regulatory filings and therapeutic efficacy.
Identification & chemistry
| Generic name | Methylprednisolone |
|---|---|
| Molecule type | Small molecule |
| CAS | 83-43-2 |
| UNII | X4W7ZR7023 |
| DrugBank ID | DB00959 |
Pharmacology
| Summary | Corticosteroids exert anti-inflammatory and immunosuppressive effects primarily through binding to the glucocorticoid receptor, modulating gene expression to inhibit inflammatory transcription factors and promote anti-inflammatory mediators. They decrease capillary permeability, leukocyte migration, and the formation of arachidonic acid derivatives, while also affecting neutrophil function. Their pharmacodynamic profile includes a wide therapeutic window and dose-dependent effects ranging from anti-inflammatory to immunosuppressive actions. |
|---|---|
| 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. 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 | agonist |
ADME / PK
| Absorption | Oral methylprednisolone has 89.9% the bioavailability of oral methylprednisolone acetate, while rectal methylprednisolone has 14.2% the bioavailability. Intravitreal methylprednisolone has a T<sub>max</sub> of 2.5h. Approximately 1/10 of an oral or IV dose of methylprednisolone will reach the vitreous humor. Further data regarding the absorption of methylprednisolone are not readily available. |
|---|---|
| Half-life | Methylprednisolone has a half life of 2.3h. |
| Protein binding | Methylprednisolone is 76.8% protein bound in plasma and does not significantly bind to corticosteroid binding protein. Methylprednisolone is bound to human serum albumin in plasma. |
| Metabolism | The metabolism of methylprednisolone is thought to be mostly mediated by 11beta-hydroxysteroid dehydrogenases and 20-ketosteroid reductases. |
| Route of elimination | Methylprednisolone and its metabolites have been collected in urine in humans. A study in dogs showed 25-31% elimination in urine and 44-52% elimination in feces. |
| Volume of distribution | The average volume of distribution of methylprednisolone is 1.38L/kg. |
| Clearance | The average plasma clearance of methylprednisolone is 336mL/h/kg. |
Formulation & handling
- Methylprednisolone is a small molecule corticosteroid available in multiple forms including oral, topical, and various injectable formulations for systemic and local administration.
- Due to its low water solubility and moderate lipophilicity (LogP 1.56), formulation approaches should consider solubilization and suspension stability, especially for parenteral suspensions and injectables.
- Oral administration should be taken with food to reduce gastrointestinal irritation, and handling requires attention to avoid degradation in moisture-sensitive powder forms used for injection.
Regulatory status
| Lifecycle | The API's key patents have expired or are approaching expiry in the US and Canada, leading to increased availability of generic versions and greater market maturity in these regions. Product offerings are primarily centered around established formulations with standard regulatory approvals. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Methylprednisolone includes multiple originator companies alongside a broad array of generic manufacturers and packagers, indicating a well-established supply base. Branded products, such as Depo-Medrol, have a strong presence primarily in the US and Canadian markets. Given the extensive list of generic manufacturers and packagers, patent expiries have either occurred or are imminent, facilitating existing generic competition. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is >4g/kg. The intraperitoneal LD<sub>50</sub> in mice is 2292mg/kg and in rats is 100mg/kg. 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. Treat acute overdoses with symptomatic and supportive therapy, while chronic overdoses will require temporarily reduced dosages. |
|---|
- Acute toxicity varies by administration route: oral LD50 in rats exceeds 4 g/kg, while intraperitoneal LD50 is 2292 mg/kg in mice and 100 mg/kg in rats
- Chronic exposure to high doses may result in systemic toxicities including endocrine, metabolic, ocular, musculoskeletal, and immunosuppressive effects
- Handling requires measures to prevent prolonged exposure and environmental release due to potential adverse effects associated with chronic dosing
Methylprednisolone 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.
Methylprednisolone (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.
Methylprednisolone API manufacturers & distributors
Compare qualified Methylprednisolone API suppliers worldwide. We currently have 16 companies offering Methylprednisolone 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 |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | CoA, GMP, ISO9001, MSDS | 170 products |
| Envee Drugs Pvt Ltd | Producer | India | India | CoA, GMP, ISO9001 | 16 products |
| Farmabios | Producer | Italy | Italy | CoA, ISO9001, USDMF | 58 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 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 |
| Henan Lihua | Producer | China | China | CoA, USDMF | 7 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 93 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Symbiotec Pharma | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 50 products |
| Tianjin Tianyao | Producer | China | China | CEP, CoA, FDA, USDMF | 24 products |
| Zhejiang Xianju | Producer | China | China | CEP, CoA, FDA, KDMF, USDMF | 17 products |
When sending a request, specify which Methylprednisolone 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 Methylprednisolone 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.
