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FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.


Ligand-owned, Captisol® was invented in 1990 by scientists at the University of Kansas Higuchi Biosciences Center for use in drug development and formulation.

The Captisol® technology is used to address the limitations of currently marketed drugs. Eleven FDA-approved, Captisol-enabled® medications are marketed by: Pfizer, Bristol-Myers Squibb, and Baxter International. Captisol® also has License and Supply Agreements (LSAs) in place with a number of pharmaceutical companies worldwide with Captisol-enabled® product candidates. Routes of administration investigated include parenteral, oral, ophthalmic, nasal, topical, oral, and inhalation.

The regulatory acceptance of Captisol® is supported by extensive safety studies demonstrating its excellent systemic safety profile. In 1999, a Type V Drug Master File (DMF) was filed with the FDA. This regulatory safety data package, which includes greater than 70 volumes, supports the use of Captisol® in parenteral formulations as well as support for other routes of delivery. Multiple FDA divisions and ex-US regulatory agencies have evaluated the data package and permitted the use of Captisol® in clinical trials.

Captisol® is an established enabling technology with substantial characterization, safety documentation and regulatory review. In 1999, a Drug Master File Type V, containing preclinical and clinical safety data for Captisol® was filed with the US Food and Drug Administration. Published in scientific articles and utilized in a number of ongoing clinical trials by leading pharmaceutical and biotech companies, Captisol® is recognized as a valuable and vital delivery technology whose use could mean the success or failure of a development program.

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