Regulatory Aspects of Captisol

How does the FDA view cyclodextrins and complexes?

To date, CyDex's experience is that the FDA has viewed cyclodextrin containing formulations as containing a separate drug and an excipient. 

Is Captisol® an approved excipient in the United States?

There is no approval process for pharmaceutical excipients in the U.S., only the products that contain them. Regulatory filings for drug products containing Captisol® have been filed with, and reviewed by, several divisions in the FDA.

What is the quality of Captisol® sold by CyDex?

All Captisol® sold is produced under strict adherence to USP and IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients. Each lot is thoroughly analyzed and must meet analytical specifications before release.

Is a Drug Master File (DMF) available for Captisol®?

A Type V DMF was filed in the U.S. in August 1999 and contains a summary of the safety data package for Captisol®. A Type IV DMF was filed in the U.S. in July 2007 and contains a summary of CMC information for Captisol®. Updates are filed on an annual basis. With a license agreement and letter of authorization, clients can reference the DMFs in their regulatory filings. CyDex can also provide clients additional Captisol® information that may be used to supplement their regulatory filings. 

Does Captisol® have GRAS status?

GRAS status is only applicable to food additives. While a GRAS excipient can be used in a pharmaceutical product, its application is as a food additive.

How to Use Captisol®

View our easy-to-use PDF for more information on how to use Captisol®

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