title: Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols.
abstract: The aim of the present study was to assess the properties of rapidly disintegrating (RD) tablets manufactured by the phase transition method. RD tablets were produced by compressing powder containing erythritol (melting point: 122 degrees C) and xylitol (melting point: 93 approximately 95 degrees C), and then heating at about 93 degrees C for 15 min. The hardness and oral disintegration time of the heated tablets increased with an increase of the xylitol content. These results suggested that the heating process and xylitol content might influence the properties of RD tablets. Then we evaluated the physicochemical properties of the RD tablets, including the median pore size, crystallinity, hardness, and oral disintegration time of tablets made with and without heating. After heating, the median pore size of the tablets was increased and tablet hardness was also increased. The increase of tablet hardness with heating and storage did not depend on the crystal state of the lower melting point sugar alcohol. It is concluded that a combination of low and high melting point sugar alcohols, as well as a phase transition in the manufacturing process, are important for making RD tablets without any special apparatus.
authors.affiliation: Tokyo Pharmaceutical Research Center, Pharmaceutical Technology Research Laboratories, Daiichi Pharmaceutical Co., Ltd., 1-16-13 Kita-Kasai, Edogawa-ku, Tokyo 134-8630, Japan. kunoybqo@daiichipharm.co.jp
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Kuno
authors.forename: Masazumi
authors.initials: M
authors.lastname: Kojima
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ando
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nakagami
mesh_terms: D003692:Delayed-Action Preparations; D004339:Drug Compounding; D005079:Excipients; D006244:Hardness; D016062:Porosity; D011208:Powders; D012995:Solubility; D013402:Sugar Alcohols / Q000737:chemistry*; D013607:Tablets
chemical_list: D003692:Delayed-Action Preparations; D005079:Excipients; D011208:Powders; D013402:Sugar Alcohols; D013607:Tablets