{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,9]],"date-time":"2026-08-09T11:15:19Z","timestamp":1786274119784,"version":"build-2736575974"},"reference-count":18,"publisher":"MDPI AG","issue":"24","license":[{"start":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T00:00:00Z","timestamp":1607644800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>Vitamin D plays a crucial and very well-known role in regulation of calcium homeostasis and bone metabolism and mineralization. However, a huge and more recent body of evidence supports the positive influence of vitamin D on the regulation of immune response, ranging from protection against respiratory tract infections to prevention and management of asthma. Nevertheless, vitamin D deficiency is a very common condition and there is an increasing need for suitable products for proper supplementation, allowing good compliance also in specific populations. Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements. This study describes a 2000 IU Vitamin D3 ODF for daily intake, consisting of hydrophilic polymers and suitable excipients, manufactured by film-casting process. Elongation-at-break (E%), Young\u2019s modulus (Y), and tensile strength (TS) were investigated using a dynamometer. Chemical stability was evaluated assaying the vitamin D3 in the films stored at different environmental conditions. In addition, in vitro disintegration and dissolution studies were performed. Correlation existed between the mechanical properties of the film and the residual water, acting as plasticizer. The stability study showed that vitamin D3 assay was \u226590% also after 3 months at 40 \u00b0C. The film disintegrated in less than 1 min and the vitamin D3 released was \u226575% after 15 min. An ODF with suitable properties can be manufactured and used as innovative dosage form for vitamin D3 food supplements.<\/jats:p>","DOI":"10.3390\/molecules25245851","type":"journal-article","created":{"date-parts":[[2020,12,14]],"date-time":"2020-12-14T00:45:36Z","timestamp":1607906736000},"page":"5851","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation"],"prefix":"10.3390","volume":"25","author":[{"given":"Irma Elisa","family":"Cupone","sequence":"first","affiliation":[{"name":"IBSA Farmaceutici Italia, 26900 Lodi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Dellera","sequence":"additional","affiliation":[{"name":"IBSA Farmaceutici Italia, 26900 Lodi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4194-7925","authenticated-orcid":false,"given":"Fabio","family":"Marra","sequence":"additional","affiliation":[{"name":"IBSA Farmaceutici Italia, 26900 Lodi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3631-5114","authenticated-orcid":false,"given":"Andrea Maria","family":"Giori","sequence":"additional","affiliation":[{"name":"IBSA Farmaceutici Italia, 26900 Lodi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2020,12,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1159\/000486536","article-title":"Vitamin D: Classic and novel actions","volume":"72","author":"Gil","year":"2018","journal-title":"Ann. Nutr. Metab."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"482","DOI":"10.1016\/j.coph.2010.04.001","article-title":"Vitamin D: Modulator of the immune system","volume":"10","author":"Baeke","year":"2010","journal-title":"Curr. Opin. Pharmacol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2502","DOI":"10.3390\/nu5072502","article-title":"Vitamin D and immune function","volume":"5","author":"Prietl","year":"2013","journal-title":"Nutrients"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"107","DOI":"10.7861\/clinmed.2020-0301","article-title":"Does vitamin D deficiency increase the severity of COVID-19?","volume":"20","author":"Weir","year":"2020","journal-title":"Clin. Med."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Bergman, P., Lindh, A.U., Bjorkhem-Bergman, L., and Lindh, J.D. (2013). Vitamin D and Respiratory Tract Infections: A SystematicReview and Meta-Analysis of Randomized ControlledTrials. PLoS ONE, 8.","DOI":"10.1371\/journal.pone.0065835"},{"key":"ref_6","unstructured":"Nurshad, A. (2020). Role of vitamin D in preventing of COVID-19 infection, progression and severity. J. Infect. Public Health."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Amrein, K., Scherkl, M., Hoffmann, M., Sommeregger, S.N., Kostenberger, M., Berish, A.T., Martucci, G., Pinz, S., and Malle, O. (2020). Vitamin D deficiency 2.0: An update on the current status worldwide. Eur. J. Clin. Nutr.","DOI":"10.1038\/s41430-020-0558-y"},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Calton, E.K., Keane, K.N., Newsholme, P., and Soares, M.J. (2015). The Impact of Vitamin D Levels on inflammatory status: A systematic review of immune cell studies. 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