title: Reduction in the volume of water for ingesting orally disintegrating tablets of solifenacin (Vesicare® OD), and the clinical disintegration time of Vesicare® OD after unit-dose packaging.
abstract: This study aimed to determine the amount of water required for ingesting an orally disintegrating tablet (ODT) of solifenacin (Vesicare(®), VES) and VES conventional tablets (VES-CT). We measured the disintegration time of VES-ODT in the oral cavity (clinical disintegration time) before and after unit-dose packaging. Thirty healthy volunteers participated in this randomized crossover trial. The participants were asked to drink water during the intake placebos of VES and after the disintegration of placebos of VES-ODT in their oral cavity. The amounts of water required for ingesting placebos of VES-CT and of VES-ODT were 42.8±27.0 mL and 20.0±23.7 mL, respectively, which indicated that the amount of water required for ingesting ODTs was significantly lesser than that for ingesting CTs. Furthermore, 5 (16.7%) participants did not require water for ingesting the ODTs. Clinical disintegration time of VES-ODT was 21.4s in 10 healthy volunteers. This clinical disintegration time did not change significantly after unit-dose packaging or subsequent storage for 56 days. This study showed that the amount of water required for ingesting VES-ODT is lower than that for ingesting VES-CT.
authors: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Shizuoka 422-8526, Japan.
authors: Shinya
authors: S
authors: Uchida
authors: Tomohiro
authors: T
authors: Yoshita
authors: Noriyuki
authors: N
authors: Namiki
mesh_terms: D000284:Administration, Oral; D018592:Cross-Over Studies; D004349:Drug Packaging; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000737:chemistry*; D011812:Quinuclidines / Q000008:administration & dosage / Q000737:chemistry*; D000069464:Solifenacin Succinate; D012995:Solubility; D013607:Tablets; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000737:chemistry*; D014867:Water / Q000737:chemistry*; D055815:Young Adult
chemical_list: D018727:Muscarinic Antagonists; D011812:Quinuclidines; D013607:Tablets; D044005:Tetrahydroisoquinolines; D014867:Water; D000069464:Solifenacin Succinate