API Crystallization Services
Identifying, developing, and obtaining the best crystalline form of an API is crucial in drug development. It has a significant impact on the effectiveness of the drug product formulation and, in particular, the bioavailability of the finished dosage form.
Our Solid State Centre of Excellence is a dedicated resource of experts to support your API projects with crystallization investigations, including solubility tests, salt screening, polymorphism screening, and optimization of the crystallization processes in your final API route.
Solid State Centre of Excellence
CordenPharma’s Solid State Centre of Excellence offers sophisticated process development where we address critical process parameters and critical quality attributes, in order to deliver the most suitable crystalline form of your API.
We also provide analytical services dedicated to solid state characterization, including differential scanning calorimetry (DSC), hot-stage microscopy, TGA-FTIR, water uptake / dynamic vapor sorption (DVS), particle size (PSD), TG-FTIR and X-ray powder diffraction.
Our Crystallization Capabilities
- Salt screening, development and selection
- Polymorphism screening
- Co-crystal development and screening
- Solubility and crystallization screening; optimization of crystallization processes
- Process development and scale-up
- Identification of critical parameters for scale-up, definition of filtration and drying parameters, polymorph control
- Racemate separation via resolution
- Pre-formulation development and support via our bioavailability enhancement services group
Want to find out more?
Get in touch with our team of experts to explore bespoke end-to-end CDMO support of your complete drug lifecycle
at any scale.