title: Evaluation of the ease of taking mini-tablets compared with other tablet formulations in healthy volunteers.
abstract: "Mini-tablets" (MTs) are tablets of diameter≤3mm and have been widely studied and developed. However, reports comparing MTs with other tablet formulations are few. We wished to evaluate the ease of taking a MT quantitatively in comparison with an orally disintegrating mini-tablet (ODMT), conventional tablet (CT) and conventional orally disintegrating tablet (ODT). Four types of tablets were prepared. We prepared tablets of two diameters (3mm for MTs and ODMTs vs. 8mm for CTs and ODTs) and two formulations (MTs and CTs vs. ODMTs and ODTs). Our randomized crossover trial in 18 healthy volunteers (8 men and 10 women; mean age, 22.5years) indicated that the visual analog scale (VAS) score for the ease and amount of water required for intake of MTs was significantly lower than those of CTs. An ODMT required the least amount of water and smallest VAS score for the ease of taking a tablet. Our results showed that the advantage of MTs with regard to the ease of taking and decreased amount of water required was exerted for a unit of dosing comprising <5 tablets. These data suggested the usefulness of MTs and the importance of the number of MTs for comfortable consumption by patients.
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan; Pharmaceutical Research and Technology Labs., Technology, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Hayakawa
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Uchida
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan. Electronic address: namiki@u-shizuoka-ken.ac.jp.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Namiki
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D013607:Tablets / Q000008:administration & dosage* / Q000737:chemistry; D064232:Visual Analog Scale; D014867:Water / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D013607:Tablets; D014867:Water
keywords: Mini-tablet; Orally disintegrating tablet; VAS score; Water intake