Purpose This study aimed to develop a polyvinyl pyrrolidone (PVP)-based amorphous solid dispersion (ASD) to prevent the crystallization of tegoprazan (TPZ) during long-term storage condition and to secure the basis for the commercial tablet manufacturing.

Methods The solubility of TPZ-ASD was assessd in water and buffer solutions. Flowability was assessed using Carr\'s Index and Hausner ratio, comparing TPZ-ASD with amorphous TPZ (TPZ-Am) and TPZ crystalline (TPZ-Cr). Long-term recrystallization was monitored using differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD) under long-term (25℃, 60% RH) and accelerated (40℃, 75% RH) conditions. Dissolution of TPZ-ASD tablets was compared with commercial product in pH 1.2 buffer and water. 

Results TPZ-ASD exhibited approximately 20-fold increase in water solubility compared to TPZ-Cr and improved solubility under all tested pH conditions. Flowability assessments indicated better performance of TPZ-ASD compared to TPZ-Cr and TPZ-Am. Stability studies revealed no recrystallization for 24 months (raw material) and 12 months (tablet) under long-term and for 6 months under accelerated conditions. The human pharmacokinetic study proposed that TPZ-ASD tablet was bioequivalent with commercial product. 

Conclusion TPZ-ASD suppressed TPZ crystallization for a long time. TPZ-ASD formulation is suitable for commercial manufacturing, as demonstrated by Phase 1 pharmacokinetics.