title: Quantitative evaluation of the disintegration of orally rapid disintegrating tablets by X-ray computed tomography.
abstract: To measure the rapid disintegration of Oral Disintegrating Tablets (ODT), a new test (XCT) was developed using X-ray computing tomography (X-ray CT). Placebo ODT, rapid disintegration candy (RDC) and Gaster®-D-Tablets (GAS) were used as model samples. All these ODTs were used to measure oral disintegration time (DT) in distilled water at 37±2°C by XCT. DTs were affected by the width of mesh screens, and degree to which the tablet holder vibrated from air bubbles. An in-vivo tablet disintegration test was performed for RDC using 11 volunteers. DT by the in-vivo method was significantly longer than that using the conventional tester. The experimental conditions for XCT such as the width of the mesh screen and degree of vibration were adjusted to be consistent with human DT values. Since DTs by the XCT method were almost the same as the human data, this method was able to quantitatively evaluate the rapid disintegration of ODT under the same conditions as inside the oral cavity. The DTs of four commercially available ODTs were comparatively evaluated by the XCT method, conventional tablet disintegration test and in-vivo method.
authors.affiliation: Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1–1–20 Shinmachi, Nishi-Tokyo 202–8585, Japan. motsuka@musashino-u.ac.jp
authors.forename: Makoto
authors.initials: M
authors.lastname: Otsuka
authors.forename: Azusa
authors.initials: A
authors.lastname: Yamanaka
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Uchino
authors.forename: Kuniko
authors.initials: K
authors.lastname: Otsuka
authors.forename: Kiyomi
authors.initials: K
authors.lastname: Sadamoto
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ohshima
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D012995:Solubility; D013607:Tablets / Q000008:administration & dosage / Q000032:analysis*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D055815:Young Adult
chemical_list: D013607:Tablets