Additional information
Manufacturer |
Ligand |
---|---|
Cas-No |
182410-00-0 |
Composition |
Sodium Sulphobutylether-beta-cyclodextrin |
Function |
Solubilizer |
Synonym |
cyclodextrin, SBE-Beta-CD |
Quality |
JP, Ph.Eur., USP/NF |
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Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs).
Captisol® is a polyanionic beta-cyclodextrin derivative with a sodium sulfonate salt separated from the lipophilic cavity by a butyl ether spacer group, or sulfobutylether (SBE). Captisol® is not a single chemical species, but comprised of a multitude of polymeric structures of varying degrees of substitution and positional/regional isomers dictated and controlled to a uniform pattern by a patented manufacturing process consistently practiced and improved to control impurities.
Traditional formulation systems for very insoluble and/or unstable active pharmaceutical ingredients (APIs) have involved a combination of organic solvents, surfactants and extreme pH conditions. These formulations may precipitate upon injection, or may cause irritation and adverse reactions. At times, these approaches are inadequate for solubilizing enough active agent for a preferred formulation.
Captisol® Solubilizes
Neutral, cationic and anionic APIs have been effectively associated with Captisol®. Aqueous solubilities have increased by a factor of 10 to 25,000, depending on the compound. In contrast to other solubilization technologies, product or traditional formulation system, the feasibility and solubility effectiveness of Captisol® can be rapidly assessed with a few simple lab experiments.
Captisol® Facilitates Delivery
Typically, the inherent pharmacokinetics and pharmacodynamics of the drug are unaffected by Captisol®, however onset may be manipulated and dose sparing maybe observed compared to classical formulations such as co-solvent based, emulsions or suspensions. Upon administration, Captisol® is readily and essentially completely renally eliminated. Captisol® formulations are biocompatible and can be administered parenterally, orally, ophthalmically, nasally, topically and via inhalation.
Product development is a complex process from discovery and evaluation through development and commercialization. Captisol® provides a useful and elegant solution to solubility and stability hurdles faced during each phase of the development process.
Combinatorial chemistry, high throughput screening (HTS) and molecular genetics have led to an increase in the number of insoluble and unstable molecules, peptides and proteins being investigated for their therapeutic activity.
The Captisol® Advantage
Attributes
Rapid Onset
Manufacturing
Enables high Levels of API to reach dosing Targets
Improved Bioavailability and Delivery Efficiency
Improved Safety, Compatibility and Convenience
Manufacturer |
Ligand |
---|---|
Cas-No |
182410-00-0 |
Composition |
Sodium Sulphobutylether-beta-cyclodextrin |
Function |
Solubilizer |
Synonym |
cyclodextrin, SBE-Beta-CD |
Quality |
JP, Ph.Eur., USP/NF |