Solid form developability evaluation technology is to evaluate the developability of crystal forms, including polymorphs, salts and cocrystals obtained in the solid form screening experiments and analyze potential risks and challenges of development. Through years of technical accumulation, Crystal Pharmatech has formed a complete evaluation system for solid form developability.
Crystal Pharmatech has mastered a variety of solid-state characterization methods, and can apply them to comprehensively investigate the in-depth physicochemical properties of drug crystal forms, and clearly reveal kinetic and thermodynamic stability, and the transformation relationship between crystal forms. The evaluation mainly includes physical and chemical properties such as solubility, stability, hygroscopicity, flowability, crystallinity, melting point, etc. The commonly used solid-state characterization methods include X-ray powder diffraction, differential scanning calorimetry, thermogravimetric analysis, dynamic water vapor adsorption analysis, particle size analysis, etc. The API will eventually be used for formulation development. To ensure the feasibility of the crystal form in the formulation process, we conduct tests on the particle attributes, processability, excipient compatibility, formulation stability, and dissolution rate, etc. The comprehensive evaluation of formulation development risk of crystal forms can then guide the development of subsequent formulation formulations, and form control strategies.
