Active Pharmaceutical Ingredient Solid-State Characterization and Pharmacokinetic Enhancement: A Multi-Technique Approach for Improved Bioavailability and Regulatory Compliance

• • Micronization reduced median particle size from 12.4 μm to 4.8 μm, yielding a 2.3-fold increase in dissolution rate at pH 6.8 (85% vs. 37% release in 30 min), directly enhancing in vivo absorption. • • Pharmacokinetic analysis in rats showed a 1.8-fold increase in AUC0-24h and 1.5-fold increase in Cmax for the micronized API, confirming improved systemic exposure. • • The API exhibited a melting point of 185.2°C (DSC) and weight loss of 0.8% up to 200°C (TGA), indicating high thermal stability and low hygroscopicity, critical for robust manufacturing. • • Accelerated stability studies (40°C/75% RH for 6 months) demonstrated no significant change in crystallinity or assay (p>0.05), ensuring shelf-life and regulatory compliance.