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Prednisolone | CAS No: 50-24-8 | GMP-certified suppliers
A medication that supports management of diverse inflammatory, autoimmune, allergic, endocrine, and rheumatic conditions for reliable therapeutic coverage across key clinical disease areas.
Therapeutic categories
Primary indications
- Prednisolone is indicated to treat endocrine, rheumatic, and hematologic disorders
- Collagen, dermatologic, ophthalmic, respiratory, and gastrointestinal diseases
- Allergic and edematous states
- And other conditions like tuberculous meningitis
Product Snapshot
- Prednisolone is available as oral solid and liquid small‑molecule formulations, parenteral injections, ophthalmic and otic solutions, rectal forms, and multiple topical preparations
- It is used across endocrine, inflammatory, immunologic, allergic, respiratory, dermatologic, ophthalmic, gastrointestinal, hematologic, and rheumatic indications
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Pharmacologically, prednisolone acts as an agonist at the glucocorticoid receptor. Receptor activation suppresses pro‑inflammatory signaling and enhances transcription of anti‑inflammatory mediators. The drug exhibits short systemic persistence, with a reported elimination half‑life of approximately 2.1 to 3.5 hours, although pharmacodynamic effects extend beyond plasma exposure due to gene‑regulatory mechanisms. Dose response varies widely, with lower doses producing predominantly anti‑inflammatory effects and higher doses exerting immunosuppressive activity.
The mechanism of action involves early suppression of vasodilation, capillary permeability, and leukocyte trafficking, followed by transcriptional effects occurring over hours to days. Prednisolone inhibits phospholipase A2 and downstream arachidonic acid pathways, and reduces activity of NF‑κB and related inflammatory transcription factors. It also promotes expression of anti‑inflammatory mediators such as interleukin‑10. At sustained high exposure, glucocorticoid binding to the mineralocorticoid receptor can lead to sodium retention and potassium loss.
Safety considerations include hypothalamic‑pituitary‑adrenal axis suppression, increased susceptibility to infection, and systemic effects associated with prolonged glucocorticoid use. Monitoring requirements vary by route and duration of therapy. Both human and veterinary formulations are widely marketed under various regional brand names.
For API procurement, suppliers should provide evidence of compliance with pharmacopoeial specifications, validated impurity controls, and consistent stereochemical integrity. Robust documentation of manufacturing practices and stability data supports regulatory submissions and formulation development.
Identification & chemistry
| Generic name | Prednisolone |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-24-8 |
| UNII | 9PHQ9Y1OLM |
| DrugBank ID | DB00860 |
Pharmacology
| Summary | Prednisolone acts as a glucocorticoid receptor agonist, altering gene transcription to suppress pro‑inflammatory pathways and enhance anti‑inflammatory signaling. Its activity includes inhibition of phospholipase A2 and NF‑κB, reducing arachidonic acid–derived mediators and leukocyte migration. At higher systemic exposure, it also engages mineralocorticoid receptors, contributing to electrolyte‑regulating effects. |
|---|---|
| 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.Prednisolone has a short duration of action as the half life is 2.1-3.5 hours.Corticosteroids have a wide therapeutic window as patients make 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 | Oral prednisolone reaches a C<sub>max</sub> of 113-1343ng/mL with a T<sub>max</sub> of 1.0-2.6 hours.Oral prednisolone is approximately 70% bioavailable. |
|---|---|
| Half-life | Prednisolone has a plasma half life of 2.1-3.5 hours.This half life is shorter in children and longer in those with liver disease. |
| Protein binding | Prednisolone's protein binding is highly variable, ranging from 65-91% in healthy patients. |
| Metabolism | Prednisolone can be reversibly metabolized to [prednisone] which is then metabolized to 17α,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20α-dihydro-prednisone (M-V), 6βhydroxy-prednisone (M-XII), 6α-hydroxy-prednisone (M-XIII), or 20β-dihydro-prednisone (M-IV).20β-dihydro-prednisone is metabolized to 17α,20ξ,21-trihydroxy-5ξ-pregn-1-en-3,11-dione(M-XVIII).Prednisolone is metabolized to Δ6-prednisolone (M-XI), 20α-dihydro-prednisolone (M-III), 20β-dihydro-prednisolone (M-II), 6αhydroxy-prednisolone (M-VII), or 6βhydroxy-prednisolone(M-VI).6αhydroxy-prednisolone is metabolized to 6α,11β,17α,20β,21-pentahydroxypregnan-1,4-diene-3-one (M-X).6βhydroxy-prednisolone is metabolized to 6β,11β,17α,20β,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6β,11β,17α,20α,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6β,11β,17α,21-tetrahydroxy-5ξ-pregn-1-en-3,20-dione (M-XIV).MVIII is metabolized to 6β,11β,17α,20β,21-pentahydroxy-5ξ-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6β,11β,17α,20α,21-pentahydroxy-5ξ-pregn-1-en-3-one (M-XVI) and then to MXIV.These metabolites and their glucuronide conjugates are excreted predominantly in the urine. |
| Route of elimination | Prednisolone is over 98% eliminated in urine. |
| Volume of distribution | A 0.15mg/kg dose of prednisolone has a volume of distribution of 29.3L, while a 0.30mg/kg dose has a volume of distribution of 44.2L. |
| Clearance | A 0.15mg/kg dose of prednisolone has a clearance of 0.09L/kg/h, while a 0.30mg/kg dose has a clearance of 0.12L/kg/h. |
Formulation & handling
- Oral formulations benefit from co‑administration with food to reduce gastric irritation, but food has minimal impact on systemic availability.
- Low aqueous solubility supports use of suspensions for ophthalmic and parenteral depot products and may require solubilizers or pH adjustment for solution formulations.
- Solid‑state stability is good, but solutions are prone to hydrolysis and typically require protection from light and controlled pH during manufacturing and storage.
Regulatory status
| Lifecycle | Most U.S. patents covering the API have expired, with one remaining patent extending protection until 2028, indicating a late-stage lifecycle with limited remaining exclusivity. In the US and Canada, the market is expected to reflect a mature competitive environment as expirations progress. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Prednisolone is an established corticosteroid with early originator development but a supply base now dominated by numerous generic manufacturers and packagers across the US and Canada. Branded products remain available in North America, but market presence is largely generic due to widespread post‑patent production. Most historical patents have expired, with only one later‑expiring US patent extending to 2028, indicating mature generic competition with limited remaining exclusivity. |
|---|
Safety
| Toxicity | The intraperitoneal LD<sub>50</sub> in rats is 2g/kg and 65mg/kg in mice.The subcutaneous LD<sub>50</sub> in rats is 147mg/kg and >3500mg/kg in mice.The oral LD<sub>50</sub> in mice is 1680mg/kg.In humans, the oral TDLO in men is 9mg/kg/2W and in women is 14mg/kg/13D. Patients experiencing an overdose of prednisolone may present with gastrointestinal disturbances, insomnia, and restlessness.Overdose of oral prednisolone may be treated by gastric lavage or inducing vomiting if the overdose was recent, as well as supportive and symptomatic therapy.Chronic overdosage may be treated by dose reduction or treating patients on alternate days.An overdose by the ophthalmic route is not expected to cause problems. |
|---|
- Acute toxicity varies widely by species and route, with reported LD50 values ranging from 65 mg/kg (mouse, intraperitoneal) to ›3500 mg/kg (mouse, subcutaneous), indicating route‑dependent tolerability
- Human TDLO data (9 mg/kg over 2 weeks in men
- 14 mg/kg over 13 days in women) suggest a low threshold for systemic adverse effects with sustained exposure
Prednisolone 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.
Prednisolone (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.
Prednisolone API manufacturers & distributors
Compare qualified Prednisolone API suppliers worldwide. We currently have 20 companies offering Prednisolone 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, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cerata Pharmaceuticals LL... | Producer | India | India | CoA, FDA, GMP | 34 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Curia | Producer | United States | Spain | CoA, GMP, MSDS, USDMF | 106 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 |
| Henan Lihua | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 7 products |
| Jiangsu Grand Xianle | Producer | China | China | CEP, CoA, FDA, GMP | 2 products |
| Jiangsu Jiaerke | Producer | China | China | CoA | 11 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 93 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
| Tianjin Jinjin | Producer | China | China | CoA, GMP | 12 products |
| Tianjin Tianmao | Producer | China | China | CoA | 6 products |
| Tianjin Tianyao | Producer | China | China | CEP, CoA, FDA, JDMF, USDMF | 24 products |
| Zhejiang Xianju | Producer | China | China | CEP, CoA, FDA, JDMF, KDMF, USDMF, WC | 17 products |
When sending a request, specify which Prednisolone 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 Prednisolone 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.
Frequently asked questions about Prednisolone API
Sourcing
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Technical
What is Prednisolone (CAS 50-24-8) used for?
Which therapeutic class does Prednisolone fall into?
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How does Prednisolone work?
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Is Prednisolone a small molecule?
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Regulatory
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