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Published on: August 9, 2022
Protein stabilization by cyclodextrins in the liquid and dried state
Tim Serno1, Raimund Geidobler, Gerhard Winter
1Novartis Pharma AG, Biologics Process R&D, Pharmaceutical Development, 4056 Basel, Switzerland. tim.serno@novartis.com
Advanced Drug Delivery Reviews
|September 13, 2011
Summary
Cyclodextrins effectively stabilize therapeutic proteins by preventing aggregation, a major challenge in drug development. These compounds offer versatile mechanisms, enhancing the stability of protein formulations.
Area of Science:
- Pharmaceutical Science
- Biotechnology
- Materials Science
Background:
- Protein aggregation poses significant challenges for developing stable therapeutic protein formulations and manufacturing processes.
- Cyclodextrins and their derivatives have been investigated for over 20 years as excipients for parenteral protein products.
- Research highlights the substantial potential of cyclodextrins in stabilizing therapeutic proteins.
Purpose of the Study:
- To provide a comprehensive review of research on the use of cyclodextrins and their derivatives in protein formulations.
- To discuss the mechanisms by which cyclodextrins stabilize proteins against various stress conditions.
- To explore the application of cyclodextrins in both liquid and dried protein formulations.
Main Methods:
- Literature review of scientific research on cyclodextrins in protein formulations.
- Analysis of proposed mechanisms for cyclodextrin-mediated protein stabilization.
- Discussion of experimental evidence supporting cyclodextrin efficacy.
Main Results:
- Cyclodextrins demonstrate significant potential as stabilizers for therapeutic proteins.
- Stabilization mechanisms include hydrophobic complexation and non-ionic surfactant-like effects.
- Cyclodextrins are effective in both liquid and dried formulations under various stress conditions.
Conclusions:
- Cyclodextrins are promising excipients for enhancing the stability of therapeutic protein formulations.
- Understanding stabilization mechanisms is crucial for optimizing cyclodextrin use.
- Further research can leverage cyclodextrins to overcome protein aggregation challenges.
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