Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
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FAQs

How to Solubilize a Drug with Captisol

  • The Simple Details
  • 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?
  • How does temperature affect complexation?
  • If my drug candidate is ionized, will it still complex with Captisol®?
  • Will I need to prepare and isolate the Drug: Captisol® complex for use in solid preparations?
  • Captisol® is prepared as the sodium salt. How much sodium is present in Captisol® solutions?
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Cyclodextrins General

  • 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?
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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?
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Solution and Solid State Characteristics in Captisol®

  • How can solutions of Captisol be filtered?
  • 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®?
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Affect of Captisol® on PK of Drug

  • Is the drug candidate released from the complex?
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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?
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Analytical Considerations

  • Analytical considerations with Captisol® and Captisol-enabled® formulations
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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?
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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®?
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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?
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