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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