{"paper_id":"bd92bbb9-ae54-47c2-84f7-e65766ea10ce","body_text":"Published\n:\n2025-10-01\nObjectives: To develop, optimize, and characterize danazol co-crystal-loaded tablets for enhanced solubility and dissolution in order to improve therapeutic efficacy in endometriosis treatment. Methods: Danazol co-crystals were prepared using various co-formers through a solvent evaporation technique and characterized by FTIR, DSC, and XRD. Co-crystals were formulated into tablets using direct compression and optimized through a 3² factorial design, varying sodium croscarmellose (8—24 mg) and PVP K-30 (4—20 mg) concentrations. Formulations were evaluated for pre-compression properties, physical parameters, disintegration, dissolution, and stability. Results: Danazol-malonic acid co-crystals (1:2 ratio) exhibited the highest solubility enhancement (11.42 ± 0.53 μg/mL, 13.76-fold increase). XRD confirmed the formation of a new crystalline phase with distinct peaks at 19° and 21° 2θ. The quadratic models for both disintegration time (R² = 0.9971) and drug release (R² = 0.9483) demonstrated excellent predictive capability. Formulation VF7 (24 mg sodium croscarmellose, 4 mg PVP K-30) was identified as optimal with rapid disintegration (74.0 ± 3.2 seconds) and superior dissolution (83.6 ± 3.4% at 30 minutes, 95.8 ± 2.0% at 60 minutes) compared to the marketed product (75.2 ± 2.7% at 60 minutes). The optimized formulation maintained stability under accelerated conditions (40°C/75% RH) for three months. Conclusion: The optimized danazol co-crystal tablet formulation successfully overcame the solubility and dissolution limitations of this poorly soluble drug, potentially enhancing bioavailability and therapeutic efficacy while reducing dosing frequency for endometriosis patients. 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(2025). Development and optimization of danazol co-crystal loaded tablet to treat endometriosis. Prospects in Pharmaceutical Sciences, 23(4), 220–234. https://doi.org/10.56782/pps.525\nLicence\nThis work is licensed under a Creative Commons Attribution 4.0 International License.","source_license":"CC0","license_restricted":false}