Pharmaceutical Product Development
Customization of CD-enabled pharmaceutical formulations, life-cycle management
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1 | Incorporating new APIs into final products might prove challenging: stability, solubility, bioavailability, etc. issues may arise. Several attributes of these substances can be favorably altered by cyclodextrins. Cyclodextrins themselves can also be utilized as APIs in certain cases, well supported by recent findings. |
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| CycloLab offers conducting interaction studies to select the most effective cyclodextrin for your molecule, proof of concept studies and development of a new formulation with the selected cyclodextrin. |
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3 | The developed formulation is optimized and preliminary stability studies are performed. CycloLab also supports its customers with all analytical aspects related to the formulation, reporting to authorities, IP issues (including life cycle management) and relevant documentation. |
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| Once the new formulation is finalized, CycloLab can assist you with the manufacturing of the selected cyclodextrin, even under cGMP conditions, conducting in vitro bioequivalence studies, etc. The work often result in generating intellectual property, which, of course, belongs to the sponsor. Patents of some recent works on agomelatine, dapagliflozin and cinacalcet are now public. |
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Links on the page:
- Link to FAQ
- Cyclodextrins in drug delivery systems
- Approved drug products with CDs
- Cyclodextrins in ophtamalic drug products
- Link to agomelatine patent
- Link to dapaglifozin patent
- Link to cinacalcet patent
If you are interested in this service offer:
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