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Tolevamer | CAS No: 28210-41-5 | GMP-certified suppliers
A medication that treats hyperkalemia by selectively binding and removing excess potassium ions to restore electrolyte balance in patients with elevated serum potassium levels.
Therapeutic categories
Primary indications
- Used to treat abnormally high potassium levels
Product Snapshot
- Tolevamer is available primarily as oral and rectal powder formulations for suspension or solution, as well as granules
- It is used for the management of elevated serum potassium levels
- Tolevamer holds approvals and investigational status in the US and Canadian markets
Clinical Overview
Pharmacodynamically, tolevamer functions by exchanging sodium ions for potassium ions in the intestinal lumen. This exchange reduces serum potassium concentrations by facilitating the removal of potassium via fecal excretion. Tolevamer is not systemically absorbed; instead, the potassium-bound resin complex is eliminated through the gastrointestinal tract. The typical administration routes include oral dosing, often combined with a 20% sorbitol solution at 25 grams, or rectal administration as an enema at 50 grams in 20% sorbitol.
The mechanism of action centers on the resin’s capacity as a potassium-binding agent, which helps prevent potassium reabsorption into the bloodstream. This action contributes to the correction of disturbances in electrolyte balance associated with hyperkalemia.
Beyond its primary use, tolevamer exhibits topical microbicidal and spermicidal properties, inhibiting the genital transmission of various pathogens, including HIV. However, its clinical application is predominantly focused on electrolyte management.
Safety and toxicity considerations include the risk of sodium overload, particularly in patients with compromised renal or cardiac function. The use of sorbitol in formulations may also pose risks of gastrointestinal adverse effects. Careful monitoring of electrolyte and fluid status is necessary during treatment to mitigate potential complications.
Tolevamer is classified under potassium-removing agents and cation-exchange resins, consistent with its pharmacological role. While various brands and formulations exist globally, regulatory approval status and specific indications may vary by region.
For API procurement, ensuring the resin’s purity, consistent ion-exchange capacity, and absence of residual monomers or contaminants is critical. Suppliers should provide comprehensive quality documentation and adhere to pharmacopeial standards relevant to polystyrene sulfonate resins.
Identification & chemistry
| Generic name | Tolevamer |
|---|---|
| Molecule type | Small molecule |
| CAS | 28210-41-5 |
| UNII | ZSL2FB6GXN |
| DrugBank ID | DB01344 |
Pharmacology
| Summary | Polystyrene sulfonate is a non-absorbed ion-exchange resin that binds potassium ions in the gastrointestinal tract, reducing systemic potassium absorption. By exchanging sodium ions for potassium, it facilitates the elimination of excess potassium via feces, thereby lowering serum potassium levels. This mechanism is utilized therapeutically to manage hyperkalemia. |
|---|---|
| Mechanism of action | Polystyrene sulfonate, which is not absorbed, binds excess potassium, carrying it out of the body. The indigestible potassium polystryene sulfonate complex is excreted with the faeces, preventing the absorption of potassium into the blood stream. Hence, the serum potassium level decreases. |
| Pharmacodynamics | Polystyrene sulfonate affects the exchange of sodium and potassium in the body. Polystyrene sulfonate is used to treat high levels of potassium in the blood, also called hyperkalemia. It is a potassium-binding ion-exchange resin that can be administered orally (25 grams in 20% sorbitol) or rectally (50 grams in 20% sorbitol). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Potassium | Humans | binder |
ADME / PK
| Absorption | Not absorbed following oral administration. |
|---|---|
| Half-life | none |
| Metabolism | none |
| Route of elimination | Feces. |
Formulation & handling
- Tolevamer is a small molecule API intended primarily for oral and rectal administration in powder or suspension forms.
- Formulations should consider the API's sensitivity to multivalent ions and recommend administration on an empty stomach to avoid interactions.
- Handling considerations include maintaining stability in the solid state as powders or granules, suitable for reconstitution before dosing.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is approaching patent expiry in key markets including the US and Canada, indicating an upcoming transition toward generic competition and increased market availability. This stage reflects a maturing market landscape with expanding treatment options. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for Tolevamer includes multiple packagers, indicating a diverse manufacturing base supporting its availability primarily in the US and Canadian markets. The presence of several branded products suggests established market penetration in North America. Patent expirations have allowed for existing generic competition, contributing to a competitive supply environment. |
|---|
Safety
| Toxicity | Overdose symptoms may include confusion, irritability, trouble thinking or concentrating, muscle weakness, or trouble breathing. |
|---|
- 1
- Avoid exposure to high concentrations
- Overdose may result in central nervous system effects including confusion and irritability
Polystyrene sulfonate is a type of Excipients
Excipients play a crucial role in the pharmaceutical industry as an essential category of active pharmaceutical ingredients (APIs). These chemical substances, though not intended to have therapeutic effects themselves, are vital components that assist in formulating and manufacturing drugs.
Excipients serve multiple functions in drug formulations. They provide stability, enhance drug solubility, control drug release, improve bioavailability, and facilitate drug administration. Common excipients include binders, disintegrants, lubricants, diluents, colorants, flavors, and preservatives.
Binders are responsible for holding the ingredients together and providing tablet hardness. Disintegrants enable tablets to break down into smaller particles for absorption in the body. Lubricants prevent tablet ingredients from sticking to the manufacturing equipment. Diluents, also known as fillers, increase tablet size and aid in uniformity. Colorants and flavors improve the aesthetic appeal and palatability of oral medications. Preservatives help prevent microbial growth in liquid formulations.
When formulating a drug, excipients must be carefully selected based on their compatibility with the active ingredient, manufacturing process requirements, and regulatory guidelines. Excipients undergo rigorous testing to ensure their safety, stability, and compatibility with the API. Regulatory agencies, such as the U.
S. Food and Drug Administration (FDA), provide guidelines and standards for excipient quality and use.
In conclusion, excipients are indispensable components in pharmaceutical formulations. They contribute significantly to the safety, effectiveness, and overall quality of drugs. Through their varied functions, excipients help optimize drug performance, enhance patient compliance, and ensure the consistent delivery of medications.
Polystyrene sulfonate API manufacturers & distributors
Compare qualified Polystyrene sulfonate API suppliers worldwide. We currently have 3 companies offering Polystyrene sulfonate 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 |
|---|---|---|---|---|---|
| Duchefa Farma B.V. | Distributor | Netherlands | Romania | CoA, GMP, ISO9001, MSDS | 170 products |
| Phaex Polymers | Producer | India | India | CoA, WC | 2 products |
| Purolite | Producer | United Kingdom | United States | CoA, JDMF | 2 products |
When sending a request, specify which Polystyrene sulfonate 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 Polystyrene sulfonate 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.
