What is Captisol used for?
Using Captisol® early in the development process can increase the number of candidates that can be evaluated, decrease development time and increase lead candidate survivability. Captisol® enables an aqueous formulation for many water insoluble APIs as oral, nasal, topical, ophthalmic or liquid-presented medications.
Where is cyclodextrin used?
In the pharmaceutical industry, cyclodextrins have mainly been used as complexing agents to increase the aqueous solubility of active substances poorly soluble in water, in order to increase their bioavailability and to improve stability.
Who makes captisol?
Captisol® is a patented cyclodextrin for use in drug development and formulation. FDA-approved, Captisol-enabled® medications are marketed by partners including Amgen, Pfizer, Merck & Co., Melinta Therapeutics, Acrotech Biopharma L.L.C. and Baxter International.
How do you dissolve captisol?
During grinding, add a small amount of a solvent in which the drug is soluble and water (e.g., 95% EtOH). The solvent should contain some water to solubilize the Captisol®. We have successfully used 95% ethanol/water or solutions of methanol/water or DMSO/water.
How is cyclodextrin administered?
The safety and toxicity of cyclodextrins depend on the route of administration. When administered orally, cyclodextrins are not absorbed from gastrointestinal tract and thus are practically nontoxic. This is due to their bulky and hydrophilic nature. Any absorption, if it occurs, is by passive diffusion.
How do you get cyclodextrin?
Cyclodextrins are produced from starch by enzymatic conversion. They are used in food, pharmaceutical, drug delivery, and chemical industries, as well as agriculture and environmental engineering.
What is Captisol ®?
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).
Is Captisol a non-nephrotoxic derivative of beta-CD?
A systematic study led to SBE-beta-CD (Captisol), a polyanionic variably substituted sulfobutyl ether of beta-CD, as a non-nephrotoxic derivative and HP-beta-CD, a modified CD developed by Janssen.
Who are the manufacturers of Captisol-enabled® medications?
FDA-approved, Captisol-enabled ® medications are marketed by partners including Amgen, Pfizer, Merck & Co., Melinta Therapeutics, Acrotech Biopharma L.L.C. and Baxter International. Ligand also has License and Supply Agreements (LSAs) in place with a number of other pharmaceutical companies worldwide with Captisol-enabled ® product candidates.
What is the pharmacokinetics and pharmacodynamics of Captisol®?
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.