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Betadex | CAS No: 7585-39-9 | GMP-certified suppliers
A medication that serves as an excipient to improve the solubility, stability, and bioavailability of pharmaceutical formulations through inclusion complex formation.
Therapeutic categories
Product Snapshot
- Betadex is an experimental cyclodextrin-based excipient used primarily in injectable formulations
- It is investigated for enhancing solubility and stability of drug compounds for various therapeutic applications
- Betadex currently holds experimental status and is not yet approved by regulatory agencies such as the FDA or EMA
Clinical Overview
While Betadex does not have a specified clinical indication or established pharmacodynamics, cyclodextrins in general are recognized for their ability to form inclusion complexes with various molecules. This property influences the solubility, stability, and bioavailability of pharmaceutical agents, often serving as excipients or pharmaceutical vehicles in drug formulations. The mechanism by which Betadex and related cyclodextrins operate involves encapsulating hydrophobic substances within their lipophilic cavity, thereby modifying dissolution profiles and facilitating drug delivery.
Pharmacokinetic data specific to Betadex are limited. Cyclodextrins are generally poorly absorbed upon oral administration and are largely metabolized by intestinal flora or excreted unchanged. Safety profiles of cyclodextrins indicate low systemic toxicity when used within recommended limits; however, their administration routes and doses are critical parameters. Some cyclodextrins may pose nephrotoxic risk if administered parenterally at high concentrations. Betadex’s safety and toxicity profiles remain to be fully characterized due to its experimental status.
Betadex is not currently approved for pharmaceutical use and does not represent an active pharmaceutical ingredient with direct therapeutic applications. Its role is principally as a research chemical, excipient, or industrial agent, commonly found in food additives, dietary supplements, and other non-therapeutic contexts.
For API procurement, quality specifications should emphasize purity, residual solvents, heavy metals, and microbial limits to ensure suitability for intended use. Sourcing from reputable manufacturers with compliance to pharmacopeial or relevant regulatory standards is advised to guarantee consistency and safety in downstream applications.
Identification & chemistry
| Generic name | Betadex |
|---|---|
| Molecule type | Small molecule |
| CAS | 7585-39-9 |
| UNII | JV039JZZ3A |
| DrugBank ID | DB03995 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Neopullulanase 2 | Thermoactinomyces vulgaris | |
| Maltose-binding periplasmic protein | Escherichia coli (strain K12) | |
| Maltogenic amylase | Thermus sp. IM6501 |
Formulation & handling
- Betadex is a small molecule oligosaccharide with high water solubility suitable for oral and potentially parenteral formulations. Its extremely low LogP value indicates high hydrophilicity and likely poor membrane permeability. Handling should ensure protection from moisture to maintain solid-state stability.
Regulatory status
Betadex is a type of Additives
Additives in the pharmaceutical API category refer to a group of chemical substances that are incorporated into pharmaceutical products to enhance their stability, functionality, or performance. These additives play a crucial role in ensuring the quality, safety, and efficacy of medications.
One common type of additive used in pharmaceuticals is preservatives. Preservatives are added to prevent microbial growth and maintain the integrity of the product throughout its shelf life. They help to safeguard against contamination and maintain the potency of the active pharmaceutical ingredient (API). Some commonly used preservatives include benzyl alcohol, phenol, and parabens.
Another important group of additives is antioxidants. Antioxidants are added to pharmaceutical formulations to prevent or delay the oxidation of APIs, which can lead to degradation and loss of potency. Examples of antioxidants commonly used in pharmaceuticals include ascorbic acid (vitamin C) and tocopherols (vitamin E).
In addition to preservatives and antioxidants, other additives like flavorings, colorants, and sweeteners may be incorporated into pharmaceutical products to improve their palatability and patient acceptability.
It is crucial to note that the use of additives in pharmaceuticals is strictly regulated by health authorities to ensure their safety and efficacy. Manufacturers must comply with stringent quality control standards and guidelines to guarantee the proper use and appropriate levels of additives in pharmaceutical products.
Overall, additives play a vital role in the pharmaceutical industry by enhancing the stability, functionality, and patient acceptability of medications. Their careful selection and incorporation contribute to the overall quality and effectiveness of pharmaceutical products.
Betadex API manufacturers & distributors
Compare qualified Betadex API suppliers worldwide. We currently have 1 companies offering Betadex API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
When sending a request, specify which Betadex 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 Betadex 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.
