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Prednicarbate | CAS No: 73771-04-7 | GMP-certified suppliers
A medication that provides anti-inflammatory and antipruritic relief for corticosteroid-responsive dermatoses, including atopic dermatitis, with reduced risk of skin atrophy.
Therapeutic categories
Primary indications
- For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Product Snapshot
- Prednicarbate is available primarily as topical formulations including creams, ointments, solutions, emulsions, and gels
- It is indicated for the management of corticosteroid-responsive inflammatory and pruritic dermatoses
- The product is approved in the US and Canada, with some formulations remaining investigational
Clinical Overview
The pharmacological effects of prednicarbate derive from its ability to penetrate cell membranes and bind to specific cytoplasmic glucocorticoid receptors. This receptor complex translocates to the nucleus, where it modulates gene transcription by interacting with chromatin. The resultant mRNA and protein synthesis induces the production of inhibitory enzymes that mediate anti-inflammatory effects. These actions include the suppression of edema, fibrin deposition, capillary dilatation, and leukocyte infiltration during early inflammation, and later inhibition of capillary proliferation, collagen deposition, and keloid formation.
The primary mechanism involves induction of phospholipase A2 inhibitory proteins, collectively known as lipocortins, which regulate the biosynthesis of inflammatory mediators. By inhibiting phospholipase A2 activity, prednicarbate reduces the release of arachidonic acid, the precursor for prostaglandins and leukotrienes, pivotal in the inflammatory cascade. Additionally, prednicarbate inhibits interleukin 1-alpha within keratinocytes and fibroblasts, contributing to its anti-inflammatory profile and favorable safety regarding skin thickness and atrophy.
Absorption is localized due to topical application, limiting systemic exposure. Metabolism likely involves cytochrome P450 enzymes, including CYP3A4, given its classification as a substrate and inducer, although detailed human ADME data remain limited. Safety considerations include monitoring for local adverse effects typical of corticosteroids, such as skin irritation and rare systemic effects upon extensive or prolonged use.
Prednicarbate is incorporated in dermatological preparations under various brand names and regulatory approvals worldwide. When sourcing prednicarbate APIs, attention should be paid to compliance with current Good Manufacturing Practices (cGMP), impurity profiles consistent with international pharmacopoeias, and confirmation of potency and stability suited for topical formulations. Quality attributes must ensure the absence of degradation products that may compromise safety or efficacy.
Identification & chemistry
| Generic name | Prednicarbate |
|---|---|
| Molecule type | Small molecule |
| CAS | 73771-04-7 |
| UNII | V901LV1K7D |
| DrugBank ID | DB01130 |
Pharmacology
| Summary | Prednicarbate is a topical corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects primarily through activation of the glucocorticoid receptor. This activation induces proteins that inhibit phospholipase A2, reducing the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes. The resulting modulation of gene transcription leads to decreased inflammatory cell migration, edema, and tissue remodeling associated with corticosteroid-responsive dermatoses. |
|---|---|
| Mechanism of action | In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 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 A2. |
| Pharmacodynamics | Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects of topical corticosteroids. These anti-inflammatory effects include inhibition of early processes such as edema, fibrin deposition, capillary dilatation, movement of phagocytes into the area, and phagocytic activities. Later processes, such as capillary production, collagen deposition, and keloid formation also are inhibited by corticosteroids. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
ADME / PK
| Absorption | Absorbed systemically across the stratum corneum. |
|---|---|
| Metabolism | Primarily in skin |
Formulation & handling
- Prednicarbate is a small molecule corticosteroid primarily formulated for topical and cutaneous applications, not intended for injectable or oral use.
- Low water solubility and moderate lipophilicity (LogP 3.83) suggest formulation in creams, ointments, gels, or emulsions to enhance skin penetration and stability.
- Formulations should consider stability under typical storage conditions for topical steroids, avoiding exposure to extreme humidity or temperature to maintain efficacy.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the US and Canada with patent protection expected to expire within the next two years, indicating an upcoming transition toward generic competition and increased market maturity in these regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The supply landscape for Prednicarbate involves multiple packagers with a notable presence in the US and Canadian markets. Branded products such as Dermatop are predominantly available in these regions. Given the absence of international branded products and the range of packagers, the market may experience existing or forthcoming generic competition following patent expiry. |
|---|
Prednicarbate 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.
Prednicarbate (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.
Prednicarbate API manufacturers & distributors
Compare qualified Prednicarbate API suppliers worldwide. We currently have 6 companies offering Prednicarbate 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Curia | Producer | United States | Spain | CoA, EDMF/ASMF, GMP, MSDS | 106 products |
| Edmond Pharma (Recipharm) | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 20 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP | 58 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
When sending a request, specify which Prednicarbate 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 Prednicarbate 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.
