Benefits

Product Advantages

Product development is a complex process from discovery and evaluation through development and commercialization. Captisol^® provides a useful and elegant solution to solubility and stability hurdles faced during each phase of the development process.

Combinatorial chemistry, high throughput screening (HTS) and molecular genetics have led to an increase in the number of insoluble and unstable molecules, peptides and proteins being investigated for their therapeutic activity.

The Captisol^® Advantage

• Improved Solubility
• Allows formulation of water-insoluble APIs in all dosage forms, including oral, injectables, ophthalmic, nasal, topical and inhalation products

Attributes

• Tastelessness in oral formulas (taste masking in oral, nasal and inhalation preparations)
• Reduction of irritation at site of injection in injectable formulas (parenteral)

Rapid Onset

• Potential to enable faster acting versions of many currently approved oral products

Manufacturing

• cGMP manufacturing via a validated process
• Multi-metric ton commercial scale
• Well-defined impurity profile and long term stability

Enables high levels of API to reach dosing targets

• Improved Stability
• Interaction with Captisol^® shelter the API from oxidative and hydrolytic degradation
• Protects against effects from elements such as heat and light

Improved Bioavailability and Delivery Efficiency

• Better bioavailability than methods of solubilization using nanoparticles and solvent systems
• Permits lower dosing of APIs (i.e. potential for dose sparing)
• Compatibility 

Improved Safety, Compatibility and Convenience

• Excellent safety record
• First U.S. approved products in 2002
• Simplified preparation process, eliminating the need for refrigeration for some commercial products