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Solid State Capabilities
Salt screening is the process of co-crystallising a compound in the presence of counter-ions, with the aim of identifying novel solid forms that display improved performance characteristics and is applied to any molecule with one or more basic or acidic center.
Salt forms often display improved performance characteristics over their free-form equivalent; dissolution rate, stability, and hygroscopicity can often be improved by employing a salt screening drug development strategy.
Salt forms display polymorphism in the same way as free APIs. Polymorph screening is recommended on any novel salt forms, in order to fully understand their solid-form behaviour.
Selecting the optimal solid form of an API during early drug development can mitigate the risk of failure later in development. This can be achieved through polymorph, salt and co-crystal screening.
Polymorph screening
Polymorph screening helps to identify all relevant forms of an API, investigate its properties and choose the optimal crystalline form. Conducting these screens can also help prevent the appearance of new forms in the latter stages of development.
Our scientists focus on establishing the interconversions between forms, relative stability of forms and understanding the monotropic or enantiotropic relationship between polymorphs as per the requirement.
About 90% of drug substances have the ability to exist in different crystal forms, therefore, understanding and controlling polymorphism is essential to successful pre-clinical development
Understanding polymorphism is key to eliminating batch-to-batch inconsistency and ensuring consistent in-vivo performance. With polymorphs differing in properties such as stability, hygroscopicity, and dissolution rate, some compounds can prove challenging to develop.
Polymorph screening is a regulatory requirement whether a salt, cocrystal or free form compound is chosen for development.
We recommend performing drug polymorphism screening as part of the process of selecting a pre-clinical candidate. This allows any challenges to be identified and overcome before causing any delays to the pre-clinical program.
Salt screening
Salt screening is an approach to quickly identify and assess the salt forms of an API and allows drug formulators to modify the physical properties of an API while preserving the benefits of a crystalline solid form. Salts of an API, often improve the APIs solubility, stability, crystallinity and can grow the solid-state portfolio of the API.
Co-crystal screening
Co-crystal screening can identify and assess the potential co-crystal forms of an API and provides an alternative approach to modify the physical properties of an API where salts do not achieve the desired performance or are not an option.
With state-of-the-art characterization techniques and rich experience in polymorphism screening, scientific experts at Jubilant Biosys can guide through the process of identifying hydrates, solvates, and meta-stable forms of compounds.
Our expertise in crystallization enables us to design scalable methods to reliably produce optimum solid form and provide non-GMP material for pre-clinical studies.
