{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:01:45Z","timestamp":1787029305535,"version":"build-2736575974"},"reference-count":47,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T00:00:00Z","timestamp":1781308800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background\/Objectives: Ursodeoxycholic acid (UDCA) is a bile acid widely used for the treatment of cholestatic liver diseases; however, its poor aqueous solubility represents 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-\u03b2-cyclodextrin (HP-\u03b2-CD) as a solubilizing excipient. Methods: Phase-solubility studies, Job\u2019s plot analysis, and 1H NMR spectroscopy were performed to investigate the host\u2013guest interaction between UDCA and HP-\u03b2-CD, confirming the formation of a stable 1:1 inclusion complex responsible for a marked increase in drug solubility. The aqueous solubility of UDCA increased from approximately 0.02 mg\/mL in water to 31 \u00b1 1 mg\/mL in the Wagner base containing HP-\u03b2-CD, compared to ~10 mg\/mL in the corresponding cyclodextrin-free vehicle. Chemical stability was evaluated using an HPLC method adapted from the European Pharmacopoeia, employing dual detection (refractive index and photodiode array detector) to ensure specificity and stability-indicating capability. Results: The UDCA solution (20 mg\/mL) remained chemically stable for at least 4 months under refrigerated (4\u20138 \u00b0C) and room temperature (25 \u00b0C) conditions, with only moderate degradation observed at 40 \u00b0C. Physical stability studies confirmed the absence of precipitation, phase separation, or significant pH variations under all storage conditions. Conclusions: Wagner-based formulation enabled the development of a stable and homogeneous UDCA oral solution, providing a complementary formulation strategy to conventional suspension-based preparations. This approach represents a robust and patient-oriented strategy for extemporaneous compounding, particularly suitable for pediatric use.<\/jats:p>","DOI":"10.3390\/pharmaceutics18060734","type":"journal-article","created":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T05:56:31Z","timestamp":1781675791000},"page":"734","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Extemporaneous Cyclodextrin-Based Oral Solution of Ursodeoxycholic Acid Using a Ready-to-Use Vehicle"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2124-9211","authenticated-orcid":false,"given":"Antonio","family":"Lopalco","sequence":"first","affiliation":[{"name":"Department of Pharmacy\u2014Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oriana","family":"Boscolo","sequence":"additional","affiliation":[{"name":"Departamento de Tecnolog\u00eda Farmac\u00e9utica, Facultad de Farmacia y Bioqu\u00edmica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina"},{"name":"Instituto de Tecnolog\u00eda Farmac\u00e9utica y Biofarmacia (InTecFyB), Facultad de Farmacia y Bioqu\u00edmica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina"},{"name":"Consejo Nacional de Investigaciones Cient\u00edficas y T\u00e9cnicas (CONICET), Godoy Cruz 2290, Buenos Aires C1414AAD, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Cutrignelli","sequence":"additional","affiliation":[{"name":"Department of Pharmacy\u2014Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco Pio","family":"Cicinato","sequence":"additional","affiliation":[{"name":"Department of Pharmacy\u2014Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy"},{"name":"Centro Studi e Ricerche \u201cDr. S. Fontana 1900\u20131982\u201d, Farmalabor s.r.l., 47, Piano S. Giovanni Street, 76012 Canosa di Puglia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Fontana","sequence":"additional","affiliation":[{"name":"Centro Studi e Ricerche \u201cDr. S. Fontana 1900\u20131982\u201d, Farmalabor s.r.l., 47, Piano S. Giovanni Street, 76012 Canosa di Puglia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9844-7331","authenticated-orcid":false,"given":"Silvia","family":"Lucangioli","sequence":"additional","affiliation":[{"name":"Departamento de Tecnolog\u00eda Farmac\u00e9utica, Facultad de Farmacia y Bioqu\u00edmica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina"},{"name":"Instituto de Tecnolog\u00eda Farmac\u00e9utica y Biofarmacia (InTecFyB), Facultad de Farmacia y Bioqu\u00edmica, Universidad de Buenos Aires, Junin 956, Buenos Aires C1113AAD, Argentina"},{"name":"Consejo Nacional de Investigaciones Cient\u00edficas y T\u00e9cnicas (CONICET), Godoy Cruz 2290, Buenos Aires C1414AAD, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7756-7828","authenticated-orcid":false,"given":"Nunzio","family":"Denora","sequence":"additional","affiliation":[{"name":"Department of Pharmacy\u2014Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1172","DOI":"10.1016\/j.jhep.2025.06.010","article-title":"The History and Future of Bile Acid Therapies","volume":"83","author":"Beuers","year":"2025","journal-title":"J. Hepatol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1783","DOI":"10.9734\/BJMMR\/2014\/7186","article-title":"Ursodeoxycholic Acid (UDCA) in Biliary Diseases. CAB International, 2014","volume":"4","author":"Milani","year":"2014","journal-title":"Br. J. Med. Med. Res."},{"key":"ref_3","unstructured":"Achufusi, T.G.O., Safadi, A.O., and Mahabadi, N. (2025). Ursodeoxycholic Acid. 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