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Dapsone | CAS No: 80-08-0 | GMP-certified suppliers
A medication that treats and manages leprosy and dermatitis herpetiformis with antibacterial and anti-inflammatory properties for consistent pharmaceutical use.
Therapeutic categories
Primary indications
- For the treatment and management of leprosy and dermatitis herpetiformis
Product Snapshot
- Dapsone is available in oral tablet and topical gel formulations
- It is primarily indicated for the treatment and management of leprosy and dermatitis herpetiformis
- The product is approved and investigational in key regulatory markets including the US and Canada
Clinical Overview
Pharmacodynamically, dapsone functions as an antimicrobial agent with immunosuppressive effects. Its mechanism of action involves the inhibition of folic acid synthesis in susceptible organisms. Specifically, dapsone competitively inhibits dihydropteroate synthetase by mimicking para-aminobenzoate (PABA), thereby disrupting the production of dihydrofolic acid, a critical precursor in nucleic acid synthesis. Its anti-inflammatory activity is recognized but remains incompletely characterized.
Following oral administration, dapsone is rapidly and almost completely absorbed from the gastrointestinal tract. It distributes widely throughout total body water and penetrates various tissues, with notable retention in the skin, muscle, liver, and kidneys. Drug levels can persist in these tissues for up to three weeks post-therapy cessation, reflecting extensive tissue binding. Dapsone undergoes hepatic metabolism involving multiple cytochrome P450 enzymes, including CYP2C8, CYP2C9, CYP2C18, CYP2C19, CYP2E1, and CYP3A isoforms, highlighting the potential for drug-drug interactions mediated via these pathways.
Safety considerations include the risk of hemolytic anemia, especially in individuals with glucose-6-phosphate dehydrogenase deficiency, methemoglobinemia, and photosensitivity reactions. Monitoring during therapy is critical to managing dose-related toxicities.
From an API sourcing perspective, quality assurance should focus on strict control of impurity profiles and batch-to-batch consistency due to dapsone’s narrow therapeutic index and potential toxicities. Compliance with pharmacopeial standards, including tests for residual solvents and heavy metals, is essential to ensure the suitability of dapsone for pharmaceutical formulation purposes.
Identification & chemistry
| Generic name | Dapsone |
|---|---|
| Molecule type | Small molecule |
| CAS | 80-08-0 |
| UNII | 8W5C518302 |
| DrugBank ID | DB00250 |
Pharmacology
| Summary | Dapsone inhibits bacterial and protozoal growth by competitively blocking dihydropteroate synthase, thereby disrupting dihydrofolic acid synthesis. It exhibits both antibacterial and anti-inflammatory properties, with its immunosuppressive effects being mechanistically distinct from its antimicrobial action. Primarily utilized in multidrug regimens for leprosy, dapsone also targets inflammatory conditions such as dermatitis herpetiformis. |
|---|---|
| Mechanism of action | Dapsone acts against bacteria and protozoa in the same way as sulphonamides, that is by inhibiting the synthesis of dihydrofolic acid through competition with para-amino-benzoate for the active site of dihydropteroate synthetase. The anti-inflammatory action of the drug is unrelated to its antibacterial action and is still not fully understood. |
| Pharmacodynamics | Dapsone is a sulfone with anti-inflammatory immunosuppressive properties as well as antibacterial and antibiotic properties. Dapsone is the principal drug in a multidrug regimen recommended by the World Health Organization for the treatment of leprosy. As an anti-infective agent, it is also used for treating malaria and, recently, for Pneumocystic carinii pneumonia in AIDS patients. Dapsone is absorbed rapidly and nearly completely from the gastrointestinal tract. Dapsone is distributed throughout total body water and is present in all tissues. However, it tends to be retained in skin and muscle and especially in the liver and kidney: traces of the drug are present in these organs up to 3 weeks after therapy cessation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Inactive dihydropteroate synthase 2 | Mycobacterium leprae (strain TN) | inhibitor |
| Dihydropteroate synthase 1 | Mycobacterium leprae (strain TN) | inhibitor |
ADME / PK
| Absorption | Bioavailability is 70 to 80% following oral administration. |
|---|---|
| Half-life | 28 hours (range 10-50 hours) |
| Protein binding | 70 to 90% |
| Metabolism | Hepatic, mostly CYP2E1-mediated. |
| Route of elimination | Renal |
Formulation & handling
- Dapsone is a small molecule suitable for both oral and topical formulations, including gels and tablets.
- It exhibits moderate water solubility and limited lipophilicity (LogP 1.27), influencing its formulation in aqueous and semi-solid systems.
- Food intake does not affect absorption, allowing flexible oral dosing without meal considerations.
Regulatory status
| Lifecycle | The API's key patents in the United States and Canada have expired between 2016 and 2017, except for a patent in the US expiring in 2033; the product is currently marketed in both the US and Canadian markets, indicating a mature market with ongoing patent protection for newer formulations or uses. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dapsone is manufactured primarily by Jacobus Pharmaceutical Co., with multiple packagers serving the US and Canadian markets. Branded products, including Aczone, have a strong presence in the US and Canada. Patent protection extends until 2033 in the United States, indicating limited generic competition currently but potential for future market exclusivity. |
|---|
Safety
| Toxicity | Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary. |
|---|
- Overdosage may induce nasal congestion, syncope, or hallucinations
- Monitor and manage blood pressure support as clinically indicated
- Handle with care to prevent exposure due to potential central nervous system effects
Dapsone is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Dapsone API manufacturers & distributors
Compare qualified Dapsone API suppliers worldwide. We currently have 5 companies offering Dapsone 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 |
|---|---|---|---|---|---|
| Corden Pharma | Producer | Germany | Italy | CoA, GMP | 45 products |
| Lundbeck Pharma | Producer | Italy | Italy | CoA, GMP, USDMF | 15 products |
| Medilux Labs | Producer | India | India | CoA, GMP | 10 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
When sending a request, specify which Dapsone 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 Dapsone 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.
