Solid Form Screening and Selection

Vetting of API solid forms for clinical studies is critical to maintaining the integrity of downstream processes. Crystal Pharmatech makes best-in-class decisions utilizing a data-driven, multi-disciplinary approach based on institutional knowledge and comparative analysis.

We consider the key solid-state scientific principles and study the physical properties, solubility, stability, processability, and isolation complexity to ensure the API phase and formulation are understood to a level of detail that ensures downstream process robustness.

Crystal Pharmatech has performed well over 1500 screening and selection projects for pharmaceutical compounds. Each screening is unique incorporating past learnings and focused on the specific chemistry of the compound under investigation. We utilize a tiered approach with point of observation analysis and a "see something say something" research environment.

Our Solid Form Screening and Selection includes:

　● Polymorph/Salt/Co-Crystal Screening

　　■ The ultimate goal of the polymorph screening is to investigate the polymorph landscape of the API molecule and find the thermodynamically most stable polymorph with superior stability, hygroscopicity, and melting point

　　■ The salt and co-crystal screenings aim at discovery of crystalline phases with increased solubility and bioavailability for weak acids and bases or neutral compounds

　● Thermodynamic Phase Relationship

　● Stability and Solubility Evaluation

　● Physical Properties Assessment

　● Optimal Solid Form Recommendation