Posted by Researchers from Italy and Argentina developed a HPBCD-based oral solution of ursodeoxycholic acid (UDCA), a bile acid widely used for the treatment of cholestatic liver diseases; to overcome its poor aqueous solubility representing a major limitation for the development of oral liquid formulations, particularly in pediatric patients requiring accurate and flexible dosing. This study aimed to develop and characterize a fully solubilized extemporaneous UDCA oral formulation using the ready-to-use vehicle Wagner, with particular emphasis on the role of hydroxypropyl-β-cyclodextrin (HP-β-CD) as a solubilizing excipient. The aqueous solubility of UDCA increased from approximately 0.02 mg/mL in water to 31 ± 1 mg/mL in the Wagner base containing HP-β-CD, compared to ~10 mg/mL in the corresponding cyclodextrin-free vehicle. The UDCA solution (20 mg/mL) remained chemically stable for at least 4 months under refrigerated (4–8 °C) and room temperature (25 °C) conditions, with only moderate degradation observed at 40 °C. Physical stability studies confirmed the absence of precipitation, phase separation, or significant pH variations under all storage conditions.
Lopalco, A.; Boscolo, O.; Cutrignelli, A.; Cicinato, F.P.; Fontana, S.; Lucangioli, S.; Denora, N. Extemporaneous Cyclodextrin-Based Oral Solution of Ursodeoxycholic Acid Using a Ready-to-Use Vehicle. Pharmaceutics 2026, 18, 734. https://doi.org/10.3390/pharmaceutics18060734
