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Pentamidine | CAS No: 100-33-4 | GMP-certified suppliers
A medication that treats pneumonia due to Pneumocystis carinii and offers antiparasitic benefits against leishmaniasis and Trypanosoma infections in immunocompromised patients.
Therapeutic categories
Primary indications
- For the treatment of pneumonia due to <i>Pneumocystis carinii</i>
Product Snapshot
- Pentamidine is available as an injectable and inhalant small molecule formulation
- It is primarily used for the treatment of Pneumocystis carinii pneumonia
- Pentamidine is approved or investigational in key regulatory markets including the US and Canada
Clinical Overview
This compound belongs to the phenol ether class, characterized chemically as an aromatic diamidine with an ether group linked to a benzene ring. Its exact mechanism of action remains incompletely defined; however, in vitro evidence suggests pentamidine interferes with nuclear metabolism by inhibiting the synthesis of DNA, RNA, phospholipids, and proteins in protozoal cells. These actions contribute to its antiparasitic effects, although the drug’s pharmacokinetic profile is not comprehensively characterized.
Clinical administration of pentamidine requires careful consideration of safety and toxicity profiles. Notable adverse effects include potential nephrotoxicity, hepatotoxicity, hematologic abnormalities such as leukopenia, thrombocytopenia, anemia, and significant metabolic disturbances including hypoglycemia, hyperglycemia, and hypocalcemia. Central nervous system toxicity, manifesting as neurological damage, has also been reported. Monitoring and maintenance of hydration during treatment can mitigate some adverse events such as renal impairment and cardiovascular effects including hypertension and hypotension. The drug is recognized as a moderate risk agent for QTc prolongation, necessitating electrocardiographic monitoring under relevant clinical circumstances.
Pentamidine is metabolized by multiple cytochrome P450 isoenzymes, including CYP2C19, CYP2D6, CYP3A, and CYP3A5, which implicates potential drug-drug interactions. It is categorized under various therapeutic classes including antiparasitic agents, antifungals, anti-infectives, and blood glucose-lowering agents, reflecting its broad pharmacologic activities.
From an API sourcing and quality perspective, pentamidine’s procurement demands adherence to rigorous pharmaceutical quality standards. Suppliers should provide comprehensive analytical characterization, including verification of chemical identity, potency, and purity. Given the drug’s toxicity profile, control of impurities and residual solvents is critical. Regulatory compliance with pharmacopeial guidelines and pharmacovigilance data is essential for secure and consistent supply chains.
Identification & chemistry
| Generic name | Pentamidine |
|---|---|
| Molecule type | Small molecule |
| CAS | 100-33-4 |
| UNII | 673LC5J4LQ |
| DrugBank ID | DB00738 |
Pharmacology
| Summary | Pentamidine is an antiprotozoal agent targeting nuclear metabolism, resulting in the inhibition of DNA, RNA, phospholipid, and protein synthesis. Its primary therapeutic application is the treatment of pneumonia caused by Pneumocystis carinii, with additional use in leishmaniasis and prophylaxis of sleeping sickness caused by Trypanosoma brucei gambiense. The pharmacodynamic effects are linked to interference with nucleic acid and protein synthesis through interactions with DNA and tRNA methyltransferase enzymes. |
|---|---|
| Mechanism of action | The mode of action of pentamidine is not fully understood. It is thought that the drug interferes with nuclear metabolism producing inhibition of the synthesis of DNA, RNA, phospholipids, and proteins. |
| Pharmacodynamics | Pentamidine is an antiprotozoal agent. It is an aromatic diamidine, and is known to have activity against <i>Pneumocystis carinii</i>. The exact nature of its antiprotozoal action is unknown. <i>in vitro</i> studies with mammalian tissues and the protozoan <i>Crithidia oncopelti</i> indicate that the drug interferes with nuclear metabolism producing inhibition of the synthesis of DNA, RNA, phospholipids and proteins. Little is known about the drug's pharmacokinetics. The medication is also useful in Leishmaniasis and in prophylaxis against sleeping sickness caused by <i>Trypanosoma brucei gambiense</i>. Hydration before treatment lessens the incidence and severity of side effects, which include liver or kidney dysfunction, hypertension, hypotension, hypoglycemia, hypocalemia, leukopenia, thrombcytopenia, anemia, and allergic reaction. It is generally well-tolerated. |
Targets
| Target | Organism | Actions |
|---|---|---|
| tRNA (cytosine(38)-C(5))-methyltransferase | Humans | other |
| DNA | Humans | intercalation |
ADME / PK
| Absorption | Absorbed poorly through the gastrointestinal tract and is usually administered parenterally. |
|---|---|
| Half-life | 9.1-13.2 hours |
| Protein binding | 69% |
| Metabolism | Hepatic. |
Formulation & handling
- Pentamidine is a small molecule API primarily formulated for parenteral use including intravenous, intramuscular, and inhalation routes.
- The compound exhibits low aqueous solubility, requiring formulation as lyophilized powder for reconstitution prior to administration.
- Handling should consider its sensitivity to moisture, and solutions must be prepared under controlled conditions to ensure stability.
Regulatory status
| Lifecycle | The API has reached patent expiry in both the US and Canada, leading to established generic competition and mature market presence in these regions. Ongoing product availability reflects a stabilized lifecycle phase. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Pentamidine is supplied by multiple manufacturers, including App Pharmaceuticals LLC, Armour Pharmaceutical Co, Baxter Healthcare Corp, Hospira Inc, and Watson Laboratories Inc, indicating a diverse originator base. Branded products like NebuPent and Pentacarinat are primarily marketed in the US and Canada. The presence of several brand formulations and established manufacturers suggests limited generic competition at this time, with no clear indication of imminent patent expirations driving generic entry. |
|---|
Safety
| Toxicity | Symptoms of overdose include pain, nausea, anorexia, hypotension, fever, rash, bad taste in mouth, confusion/hallucinations, dizziness, and diarrhea. |
|---|
- 1
- Overdose may result in multisystem symptoms including hypotension, neurological effects, and gastrointestinal disturbances
- 2
Pentamidine 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.
Pentamidine (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.
Pentamidine API manufacturers & distributors
Compare qualified Pentamidine API suppliers worldwide. We currently have 3 companies offering Pentamidine 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 |
|---|---|---|---|---|---|
| Chinoin | Producer | Hungary | Unknown | CEP, CoA, GMP | 21 products |
| Minakem | Producer | France | Canada | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF | 31 products |
| Reliable Biopharm | Producer | United States | United States | CoA, USDMF | 11 products |
When sending a request, specify which Pentamidine 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.).
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