Drug substance development is continuous troubleshooting and risk management. In the initial R&D phase, crystallization is used as purification and isolation method for the compound. Next, in parallel with the process development, the solid-state chemistry manages your drug's physchem properties by finding the polymorph that will give the perfect balance between stability, solubility and permeability. Once the first GMP batches have been produced and the first clinical studies successfully completed, a full IP screen will provide the overview of additional crystalline polymorphs, salts, co-crystals and amorphous forms.
This presentation highlights the polymorph screening process and how to optimize the phase appropriate form selection. Controlled crystallization is the preferred isolation method to obtain purified material of a specific polymorphic form and crystal habit. The systematical exploration of the experimental space will identify new crystalline (salt) forms, select the kinetically accessible and thermodynamically most stable polymorph.
This presentation was first showcased during a webinar. You can watch the recording of that webinar in the Events & Webinars section here.