Olutasidenib Type A Crystalline Solid Form

The patent utilizes parameter changes by controlling temperature, concentration, and pH during the crystallization process. The solution is heated to concentrate the compound, then cooled to induce crystallization, with pH adjustment using acid or base to control crystal formation. These parameter changes enable reproducible crystal structure definition while managing process complexity through systematic control.

The patent employs phase transitions by dissolving the compound in a solvent to form a saturated solution, then inducing crystallization through cooling and concentration changes. The transition from dissolved state to crystalline solid state is controlled through temperature reduction and solvent evaporation, achieving defined crystal structure through controlled phase change.

The patent utilizes color changes as a quick preliminary indicator to identify different solid forms. Each crystalline form exhibits distinct color characteristics that can be observed visually or through spectroscopy, providing a rapid first-level differentiation before undertaking comprehensive analytical characterization.

The patent replaces complex mechanical separation and identification methods with analytical techniques. Instead of relying on mechanical properties for form identification, the patent uses X-ray powder diffraction (XRPD) to detect crystal structure, differential scanning calorimetry (DSC) to measure thermal properties, and thermogravimetric analysis (TGA) to assess thermal stability. These analytical substitutions enable systematic characterization of multiple solid forms.

The patent creates an inert environment by forming a crystalline solid form with a defined lattice structure that protects the compound from moisture and oxygen. The crystalline structure acts as a barrier to environmental degradation, and the patent may employ encapsulation or packaging techniques to maintain an inert atmosphere around the solid form, preventing hydrolysis and oxidation while preserving therapeutic efficacy.

The patent develops a composite approach by combining the crystalline olutasidenib with pharmaceutically acceptable excipients and delivery systems. The crystalline form provides structural stability, while the formulation matrix provides additional protection against moisture and thermal degradation. This composite formulation maintains chemical stability while ensuring therapeutic efficacy.