Solid form services is the bridge between drug substance and drug product development for New Chemical Entities (NCEs). Early screening, selection, and isolation of the lead polymorph can avoid additional costs and delayed timelines due to the unexpected appearance of stable polymorphs late in development. Solid form screening of salts and cocrystals, on the other hand, can provide a stable crystalline form capable of solubility enhancement for poorly soluble drugs to improve bioavailability.
In this webinar, we discuss the role of solid form services in helping meet the accelerated timelines of the drug development lifecycle. Also, we share examples of robust workflows for fast and thorough solid form screens. A case study reviews the polymorph screen of a late stage API focusing on monotropic vs enantiotropic polymorphs. We also highlight the crystallization process development of the lead form.
Key Learning Objectives:
- Importance of solid form screening and form selection in pharmaceutical development
- Understand how monotropic and enantiotropic polymorphs are screened
- Appreciate design considerations for robust crystallization processes for lead forms