{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T01:47:27Z","timestamp":1773366447646,"version":"3.50.1"},"reference-count":23,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T00:00:00Z","timestamp":1773273600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novartis Pharma AG, Switzerland"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background: There is a paucity of systematic investigations of the acceptability and preference of alternative oral drug formulations in multiple sclerosis (MS) patients. The use of appropriate oral dosage forms has the potential to circumvent challenges associated with the ingestion of tablets. Objective: This randomized, open, cross-over study aimed to investigate acceptability, swallowability, palatability, and preference of four oral placebo drug formulations of similar sizes\/given volumes but different modes of ingestion (film-coated tablet, orodispersible tablet, orodispersible film, and gel) in MS patients. Methods: Acceptability was tested in two patient subgroups (32 participants each) of different MS disability levels (expanded disability status scale [EDSS] &lt; 4 and \u22654). The primary endpoint was acceptability derived as a composite of swallowability (rated by investigator) and palatability (rated by participant). Results: The film-coated tablet showed the highest acceptability rates for EDSS\u00a0&lt;\u00a04 and EDSS \u2265 4 (100.0%, 93.8%), followed by gel (81.3%, 68.8%). Acceptability rates for all formulations were consistently higher for EDSS\u00a0&lt;\u00a04 compared to EDSS \u2265 4. Concerning the subjective assessment of palatability, the gel received the highest rate of positive ratings, but also was frequently judged as \u2018Unpleasant\u2019. Furthermore, the gel was ranked as the first or second choice as the most-preferred formulation, followed by the film-coated tablet. All formulations were considered safe in the study population. Conclusions: Film-coated tablets are well-suited for use in MS patients and gels may represent an interesting alternative for a certain subgroup of MS patients.<\/jats:p>","DOI":"10.3390\/pharmaceutics18030353","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T13:12:24Z","timestamp":1773321144000},"page":"353","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Randomized, Open, Single-Administration, Cross-Over Study to Investigate the Acceptability, Swallowability, Palatability, and Preference of Different Oral Placebo Formulations in Patients with Multiple Sclerosis"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7888-9434","authenticated-orcid":false,"given":"Hans Martin","family":"Bosse","sequence":"first","affiliation":[{"name":"Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kotryna","family":"Karosaite","sequence":"additional","affiliation":[{"name":"Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolin","family":"Kloft","sequence":"additional","affiliation":[{"name":"Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melanie","family":"Sch\u00fctte","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Pawlitzki","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7987-658X","authenticated-orcid":false,"given":"Philipp","family":"Albrecht","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"},{"name":"Department of Neurology, Maria Hilf Clinics, 41063 M\u00f6nchengladbach, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharmishtha","family":"Chauhan","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt. Ltd., Salarpuria-Sattva Knowledge City, Raidurg Madhapur, Ranga Reddy District, Hyderabad 500 080, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9859-917X","authenticated-orcid":false,"given":"Isabelle","family":"Gallou","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Novartis Campus, 4056 Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3078-9705","authenticated-orcid":false,"given":"Sebastien","family":"Chabaud","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Novartis Campus, 4056 Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tushar","family":"Sawai","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt. Ltd., Genome Valley, Turkapally, Lalgadi Malakpet, Shamirpet Mandal, Hyderabad 500 072, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haripriya","family":"Tumuluri","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Novartis Campus, 4056 Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manfred","family":"Wargenau","sequence":"additional","affiliation":[{"name":"M.A.R.C.O. GmbH & Co. KG, Institute for Clinical Research and Statistics, 40211 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucas-Sebastian","family":"Spitzhorn","sequence":"additional","affiliation":[{"name":"M.A.R.C.O. GmbH & Co. KG, Institute for Clinical Research and Statistics, 40211 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0533-2082","authenticated-orcid":false,"given":"Viviane","family":"Klingmann","sequence":"additional","affiliation":[{"name":"Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Duesseldorf, Heinrich Heine University, 40225 Duesseldorf, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1038\/s41572-018-0041-4","article-title":"Multiple sclerosis","volume":"4","author":"Filippi","year":"2018","journal-title":"Nat. Rev. Dis. 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