{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T16:39:43Z","timestamp":1787589583420,"version":"build-2736575974"},"reference-count":42,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T00:00:00Z","timestamp":1734048000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009573","name":"Secretary of Science and Technology of UNR (SECyT-UNR)","doi-asserted-by":"publisher","award":["80020230200100UR"],"award-info":[{"award-number":["80020230200100UR"]}],"id":[{"id":"10.13039\/100009573","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009573","name":"Secretary of Science and Technology of UNR (SECyT-UNR)","doi-asserted-by":"publisher","award":["AC 2021-003"],"award-info":[{"award-number":["AC 2021-003"]}],"id":[{"id":"10.13039\/100009573","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015890","name":"ASACTeI","doi-asserted-by":"publisher","award":["80020230200100UR"],"award-info":[{"award-number":["80020230200100UR"]}],"id":[{"id":"10.13039\/501100015890","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015890","name":"ASACTeI","doi-asserted-by":"publisher","award":["AC 2021-003"],"award-info":[{"award-number":["AC 2021-003"]}],"id":[{"id":"10.13039\/501100015890","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Triclabendazole (TCB) is a well-established anthelmintic effective in treating fascioliasis, a neglected tropical disease. This study employs quality by design (QbD) to investigate the impact of TCB polymorphism and pharmacotechnical variables, from the development of immediate-release tablets to process optimization and green analysis. Critical process parameters (CPPs) and critical material attributes (CMAs), characterized by type of polymorph, composition of excipients (talc, lactose, cornstarch, and magnesium stearate), and compression force, were screened using a Plackett\u2013Burman design (n = 24), identifying polymorphic purity and cornstarch as a CPP. To establish a mathematical model linking CPP to dissolution behaviour, a multiple linear regression (MLR) was applied to the training design (central composite design, n = 18). Simultaneously, a near-infrared spectroscopy coupled to partial least squares (NIR-PLSs) method was developed to analyze CPPs. An independent set of samples was prepared and analyzed using the NIR-PLSs model, and their dissolution profiles were also obtained. The PLSs model successfully predicted the CPPs in the new samples, yielding almost quantitative results (100 \u00b1 3%), and MLR dissolution predictions mirrored the actual dissolution profiles (f2 = 85). In conclusion, the developed model could serve as a comprehensive tool for the development and control of pharmaceutical formulations, starting from the polymorphic composition and extending to achieve targeted dissolution outcomes.<\/jats:p>","DOI":"10.3390\/pharmaceutics16121594","type":"journal-article","created":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T10:34:12Z","timestamp":1734086052000},"page":"1594","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A QbD Approach for the Formulation and Control of Triclabendazole in Uncoated Tablets: From Polymorphs to Drug Formulation"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-6515-8788","authenticated-orcid":false,"given":"Lucas P.","family":"Muzi","sequence":"first","affiliation":[{"name":"\u00c1rea de An\u00e1lisis de Medicamentos, Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario and Instituto de Qu\u00edmica Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9399-5366","authenticated-orcid":false,"given":"Marina","family":"Antonio","sequence":"additional","affiliation":[{"name":"\u00c1rea de An\u00e1lisis de Medicamentos, Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario and Instituto de Qu\u00edmica Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rub\u00e9n M.","family":"Maggio","sequence":"additional","affiliation":[{"name":"\u00c1rea de An\u00e1lisis de Medicamentos, Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario and Instituto de Qu\u00edmica Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1016\/j.molstruc.2019.05.048","article-title":"Structure, characterization, solubility and stability of podophyllotoxin polymorphs","volume":"1195","author":"Gong","year":"2019","journal-title":"J. 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