Partnership details ...

How It Works

Traditional formulation systems for very insoluble and/or unstable active pharmaceutical ingredients (APIs) have involved a combination of organic solvents, surfactants and extreme pH conditions. These formulations may precipitate upon injection, or may cause irritation and adverse reactions. At times, these approaches are inadequate for solubilizing enough active agent for a preferred formulation.

Captisol® Solubilizes

Neutral, cationic and anionic APIs have been effectively associated with Captisol®. Aqueous solubilities have increased by a factor of 10 to 25,000, depending on the compound. In contrast to other solubilization technologies, product or traditional formulation system, the feasibility and solubility effectiveness of Captisol® can be rapidly assessed with a few simple lab experiments.

Captisol® Facilitates Delivery

Typically, the inherent pharmacokinetics and pharmacodynamics of the drug are unaffected by Captisol®, however onset may be manipulated and dose sparing maybe observed compared to classical formulations such as co-solvent based, emulsions or suspensions. Upon administration, Captisol® is readily and essentially completely renally eliminated. Captisol® formulations are biocompatible and can be administered parenterally, orally, ophthalmically, nasally, topically and via inhalation.

Captisol® is Safe

Captisol® was designed to maximize safety by eliminating the potentially damaging effects produced by the parent beta-cyclodextrin. In-vitro experiments and in-vivo acute, subchronic and chronic toxicity studies have provided safety data to support the development and approval of Captisol® drug formulations in man.

Captisol® Stabilizes

Interaction with Captisol® provides a beneficial and protected environment for the API in its lipophilic cavity, while Captisol's hydrophilic surface provides excellent water solubility- boosting both solubility and stability. Interaction of the API with Captisol® can reduce decomposition by protecting labile regions from the potential reactants in the aqueous environment. 

Captisol® Facilitates Faster Development

Using Captisol® early in the development process can increase the number of candidates that can be evaluated, decrease development time and increase lead candidate survivability. Captisol® enables an aqueous formulation for many water insoluble APIs as oral, nasal, topical, ophthalmic or liquid-presented medications. 

 

FDA-Approved Captisol-enabled® Drugs

Baxter InternationalBaxter International
PfizerPfizer
PfizerPfizer
PfizerPfizer
AmgenAmgen
Spectrum PharmaceuticalsSpectrum Pharmaceuticals
MerckMerck
LundbeckLundbeck
BaxdelaBaxdela

Captisol® Partnerships

CarfilzomibCarfilzomib
CarbamazepineCarbamazepine
CE formulation of MelphalanCE formulation of Melphalan

 

This is a representative listing of Captisol-enabled® partnerships

 

Partnership activites ...

  • Licensing Out
  • Distributor
 

Partnership category areas ...

  • Drug Delivery Technology
    • Drug Delivery Technology
  • Proprietary Formulations
    • Proprietary Formulations-Clinical Development
    • Proprietary Formulations-Marketed
 
 
 
 
 
 
 
 

About Us

SURIMS is the new name for Actex Pharma Services which was a consultancy established in 2003, supporting companies in the identification, qualification and management of quality vendors and suppliers in ingredients and formulations.

The Pharmaceutical Services Directory supports the identification and on-boarding of quality suppliers and also incorporates software features that manage relationships between suppliers and their customers. These include the building and deployment of questionnaires and assessments, electronic signatures and sign-offs and project management between vendor/partner and customer.

Access to the features and software is available on a 'pay as you go' basis, or a customised version can be licensed for your company for its own supplier on-boarding and supplier management activities. Further information on our software services please contact Tel: +353 87 294 0436 or email info@surims.com

 
 
 

Get in Touch

The Pharmaceutical Services Directory
info@surims.com

 
 
 

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