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Sodium stibogluconate | CAS No: 16037-91-5 | GMP-certified suppliers
A medication that treats leishmaniasis, a protozoal infection from sandfly bites, with potential applications in cancer and solid tumor therapies.
Therapeutic categories
Primary indications
- For the treatment of various types of a protozoal infection called leishmaniasis, which may result from sandfly bites in tropical and temperate parts of the world
- Also investigated for use/treatment in cancer/tumors (unspecified) and solid tumors
Product Snapshot
- Sodium stibogluconate is an injectable antiprotozoal agent administered via intramuscular or intravenous routes
- It is primarily indicated for the treatment of leishmaniasis and is under investigation for oncological applications such as solid tumors
- The compound holds approved status for leishmaniasis treatment and is investigational in other therapeutic areas
Clinical Overview
Pharmacologically, the exact mode of action of sodium stibogluconate remains incompletely elucidated. In vitro studies demonstrate that exposure of Leishmania amastigotes to the active compound results in a significant decrease in parasite DNA, RNA, protein, and purine nucleoside triphosphates. The mechanism is believed to involve inhibition of DNA topoisomerase I, leading to the disruption of DNA replication and transcription processes. This results in impaired macromolecular synthesis critical to parasite survival. Recent investigations have also explored its potential anti-tumor activity, although such applications remain experimental.
Key ADME (Absorption, Distribution, Metabolism, and Excretion) parameters are not comprehensively characterized in the literature. Sodium stibogluconate is water-soluble and administered parenterally due to poor oral bioavailability. Renal elimination is the primary route of excretion.
Safety considerations involve potential toxicity associated with antimony compounds, including cardiotoxicity, pancreatitis, hepatotoxicity, and myelosuppression. Resistance to pentavalent antimonials has emerged in endemic regions, limiting their clinical utility and prompting the use of alternative therapies such as amphotericin B or miltefosine in certain geographies.
From a sourcing and quality perspective, sodium stibogluconate APIs must meet stringent purity criteria due to the narrow therapeutic window and toxicity profile. Reliable suppliers should provide comprehensive certificates of analysis adhering to pharmacopeial standards. Controls on antimonial content, residual solvents, and heavy metals are essential to ensure safety and efficacy in final dosage forms.
Identification & chemistry
| Generic name | Sodium stibogluconate |
|---|---|
| Molecule type | Small molecule |
| CAS | 16037-91-5 |
| UNII | APJ6285Y89 |
| DrugBank ID | DB05630 |
Pharmacology
| Summary | Sodium stibogluconate acts primarily by inhibiting DNA topoisomerase I, leading to the disruption of DNA replication and transcription. This results in decreased synthesis of nucleic acids and proteins, contributing to reduced parasite viability. It is used therapeutically to treat leishmaniasis, a protozoal infection, and is under investigation for potential anticancer effects. |
|---|---|
| Mechanism of action | Sodium stibogluconate directly inhibits DNA topoisomerase I leading to inhibition of both DNA replication and transcription. |
| Pharmacodynamics | The mode of action of sodium stibogluconate is not clearly understood. In vitro exposure of amastigotes to 500 mg pentavalent antimony/ml results in a greater than 50% decrease in parasite DNA, RNA protein and purine nucleoside triphosphate levels. It has been postulated that the reduction in ATP (adenosine triphosphate) and GTP (guanosine triphosphate) synthesis contributes to decreased macromolecular synthesis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA topoisomerase 1 | Humans | inhibitor |
Formulation & handling
- Sodium stibogluconate is formulated for parenteral administration via intramuscular or intravenous injection.
- As a small molecular weight compound with high water solubility and low LogP, it is suitable for aqueous injectable formulations.
- Due to its dicarboxylic acid nature, careful pH control and stability assessment during formulation are recommended.
Regulatory status
Safety
| Toxicity | The main symptoms of antimony overdosage are gastro-intestinal disturbances (nausea, vomiting and severe diarrhoea). Haemorrhagic nephritis and hepatitis may also occur. |
|---|
- Exposure to antimony compounds may cause gastrointestinal disturbances including nausea, vomiting, and severe diarrhea
- Potential systemic toxicity includes haemorrhagic nephritis and hepatitis upon overexposure
- Appropriate containment and handling procedures are recommended to minimize risk of inhalation or ingestion
Sodium stibogluconate is a type of Antiprotozoics
Antiprotozoics are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used to combat protozoan infections. Protozoa are single-celled microorganisms that can cause severe diseases in humans, such as malaria, leishmaniasis, and toxoplasmosis. Antiprotozoic APIs play a crucial role in the development of effective medications to treat these infections.
These APIs work by targeting specific metabolic pathways or enzymes within the protozoan organisms, effectively inhibiting their growth and reproduction. By interrupting essential processes, antiprotozoics can eliminate the protozoa from the body or suppress their activity, allowing the immune system to effectively combat the infection.
Pharmaceutical companies invest significant efforts in research and development to discover and synthesize new antiprotozoic APIs. The goal is to develop highly potent and selective compounds that can effectively eradicate protozoa while minimizing side effects on the human body. This involves rigorous testing and screening of various chemical compounds to identify potential drug candidates with optimal therapeutic properties.
Antiprotozoic APIs are then used as the active ingredients in the formulation of pharmaceutical drugs, such as tablets, capsules, or injectables. These drugs are prescribed by healthcare professionals to patients suffering from protozoan infections. The selection of the appropriate antiprotozoic API depends on the specific protozoan strain and the characteristics of the infection.
In summary, antiprotozoic APIs are essential pharmaceutical ingredients that play a vital role in treating protozoan infections. Their development involves rigorous research and testing to identify potent compounds that can effectively target and eliminate protozoa, leading to improved health outcomes for patients.
Sodium stibogluconate (Antiprotozoics), classified under Antiparasitics
Antiparasitics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are used to combat parasitic infections in humans and animals. These APIs play a crucial role in the field of medicine and veterinary care by targeting and eliminating various parasites, such as protozoa, helminths, and ectoparasites.
The use of antiparasitics is essential in preventing and treating parasitic diseases, which can cause significant health issues and even be life-threatening. These APIs work by interfering with the parasite's vital biological processes, such as reproduction, metabolism, and survival mechanisms.
Pharmaceutical companies develop and manufacture a wide range of antiparasitic APIs to cater to different parasitic infections. Some common examples of antiparasitics include anthelmintics (used against intestinal worms), antimalarials (used to treat malaria), and ectoparasiticides (used to control external parasites like ticks and fleas).
The development of antiparasitic APIs requires rigorous research, including the identification of suitable targets within the parasite's biology and the formulation of effective chemical compounds. Safety and efficacy are paramount in the manufacturing of antiparasitics, ensuring that they effectively combat the targeted parasites while minimizing adverse effects on the host.
Overall, antiparasitics are vital tools in the fight against parasitic infections, benefiting both human and animal health. Through ongoing research and development, the pharmaceutical industry continues to innovate and improve antiparasitic APIs, contributing to the advancement of healthcare and the well-being of individuals and their animal companions.
Sodium stibogluconate API manufacturers & distributors
Compare qualified Sodium stibogluconate API suppliers worldwide. We currently have 2 companies offering Sodium stibogluconate API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Orgapharm | Producer | France | France | CoA, GMP | 9 products |
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