{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:17:45Z","timestamp":1791573465945,"version":"4.3.4"},"reference-count":46,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T00:00:00Z","timestamp":1760400000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018552","name":"Science and Technology Plan Project of Taizhou","doi-asserted-by":"publisher","award":["SSF20220050"],"award-info":[{"award-number":["SSF20220050"]}],"id":[{"id":"10.13039\/501100018552","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>Tofacitinib citrate (TOC) is clinically used primarily for the treatment of moderate to severe rheumatoid arthritis in patients who are intolerant or inadequately responsive to methotrexate. In this study, a new polymorph of TOC (form II) was prepared using solvent crystallization. The currently marketed form I and the self-prepared form II were characterized by XRD, DSC, FT-IR, and SEM, confirming that form II is a new polymorphic form of TOC. This new polymorph was then used in the development of TOC sustained-release tablets. In the formulation design, mannitol with low hygroscopicity was used to replace sorbitol. By adding a certain amount of microcrystalline cellulose to the tablet core and maintaining the mannitol content between 60\u2009~\u200970% of the total core weight, an in vitro dissolution behavior similar to that of the reference formulation (<jats:italic><jats:italic>f<\/jats:italic><\/jats:italic><jats:sub>2<\/jats:sub>\u2009&gt;\u200950) was achieved. This indicates that replacing sorbitol with mannitol as the osmotic agent in the osmotic pump tablet core is a practical and effective method. Additionally, key preparation processes for the TOC sustained-release tablets were investigated. The results suggest that the coating weight gain of the self-prepared sustained-release tablets should be controlled between 6% and 7%, and the suitable range for laser-drilled orifice diameter is 0.55\u2009~\u20090.90\u2009mm.<\/jats:p>","DOI":"10.1371\/journal.pone.0332664","type":"journal-article","created":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T17:30:56Z","timestamp":1760463056000},"page":"e0332664","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":3,"title":["New polymorph of tofacitinib citrate and in vitro equivalence study of its sustained-release tablets"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-6382-5711","authenticated-orcid":true,"given":"Yan","family":"Wang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuai","family":"Wen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yao","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijuan","family":"Gui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Mou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5944-7833","authenticated-orcid":true,"given":"Dongkai","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,10,14]]},"reference":[{"issue":"1","key":"pone.0332664.ref001","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1038\/nrrheum.2015.167","article-title":"Type I\/II cytokines, JAKs, and new strategies for treating autoimmune diseases","volume":"12","author":"DM Schwartz","year":"2016","journal-title":"Nat Rev Rheumatol"},{"key":"pone.0332664.ref002","article-title":"Novel crystalline compound neue kristalline verbindung nouveau compose cristallin. 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