Screening and selecting solid forms
Our solid form services (SFS) are designed for flexibility and can be readily accessed alone or as part of an integrated drug substance and/or drug product development program.
These services can be rapidly advanced into crystallization development studies, utilizing our extensive infrastructure and expertise in advanced chemical synthesis. Solid form screening and identification are also a core component of our SimpliFiH® Solutions first-in-human services.
Selecting your lead solid form early is critical
We will help you determine the most suitable chemical and physical form of an API. The selection involves the screening and characterization of chemical forms and the associated polymorphs. Every molecule has a different propensity for polymorphism and forms hydrates and solvates.
The molecule's physicochemical properties and TPP dictate the need for screening salts, cocrystals, or bioavailability-enhanced formulations and the key properties of any solid form: solubility, dissolution rate, manufacturability, stability, etc. Effective screening and selection are critical for early and late-stage development to process risk reduction and/or strengthening IP claims.
Rapidly understand your molecule
Our solid form drug services are built on a foundation of API characterization, materials science and problem statement analyses core to our API development and bioavailability-enhancement service portfolios. In-house equipment and expertise are in place to rapidly understand the solid form landscape of your molecule.
Example screens typically performed by our Solid Form Services team include:
- Characterization
- Cocrystal screen
- Hydrate mapping
- Single-crystal XRD
- Stable form screen
- Primary salt screen
- Secondary salt screen
- Preformulation screen
- Enantiomeric screening
- Primary polymorph screen
- PXRD method development
- Amorphous solid dispersions
- Secondary polymorph screen
- ASAP and traditional stability
- Salt developability assessment
- Stable form developability assessment