FAQs

Cyclodextrins General
What are cyclodextrins?
What is the difference between dextrins and dextrans?
What are modified cyclodextrins and why were they developed?
How is Captisol^® different from other modified cyclodextrins?

Captisol^® in Formulations
How does Captisol^® improve formulations?
Will Captisol^® complex with my drug candidate?
Will Captisol^® complex with peptides and proteins?
Can Captisol^® be used in injectable formulations?
Can Captisol^® be given by non-parenteral routes?
Is Captisol^® suitable for use in solid formulations?

Solution and Solid State Characteristics in Captisol^®
What are the solid state characteristics of Captisol^®?
What are the properties of Captisol^® solutions?
At what concentration is Captisol^® isotonic?
I would like to use a 30% w/v solution of Captisol® in my formulation. Will it be highly viscous?
Can Captisol^® be autoclaved?
Captisol^® is noted to be hygroscopic - how should we handle the solid material?
What is the substitution pattern of Captisol^®?

How to Solubilize a Drug with Captisol^®
What additional steps can I take to increase the solubility of my drug with Captisol^®?
Can I add an organic solvent to a Captisol^® solution to help increase the solubility of my drug?
What is the solubility of Captisol^® in water, methanol, acetonitrile, or other organic solvents?
My drug is very non-wettable, are there any techniques I can use to improve dissolution?
How does pH affect complexation?
If my drug candidate is ionized, will it still complex with Captisol^®?
Captisol^® is prepared as the sodium salt. How much sodium is present in Captisol^® solutions?

Affect of Captisol^® on PK of Drug
Is the drug candidate released from the complex?

How Much Captisol^®...?
How much Captisol^® is needed in an injectable formulation?
What is the maximum dose that can be administered per day in nonclinical studies by intravenous routes?
How much Captisol^® has been administered to humans?
How much Captisol^® is contained in the marketed formulations and how much Captisol^® is received by patients?

Analytical Considerations with Captisol^® and Captisol-enabled^® Formulations
Regulatory Aspects of Captisol^®

Regulatory Aspects of Captisol^®
How does the FDA view cyclodextrins and complexes?
Is Captisol^® an approved excipient in the United States?
What is the quality of Captisol^® sold by CyDex?
Is a Drug Master File (DMF) available for Captisol^®?
Does Captisol^® have GRAS status?

Availability of Captisol^®
How is Captisol^® supplied for research and development purposes?
How is Captisol^® supplied once full-scale commercial quantities are required?
What is the difference between clinical and non-clinical Captisol^®?

Stability, Storage & Testing
What tests should a customer perform to release Captisol^® upon receipt?
What is the expiration period of Captisol^®?
What is the expiration period of Captisol^® standard?
How stable is Captisol^®?
How stable are Captisol^® solutions?
How should Captisol^® be stored?