COMPOSITION DISINTEGRABLE IN ORAL CAVITY, AND PHARMACEUTICAL PREPARATION DISINTEGRABLE IN ORAL CAVITY

摘要

PROBLEM TO BE SOLVED: To provide a composition disintegrable in the oral cavity, having appropriate mechanical strength needed in handling a pharmaceutical preparation, and also quickly disintegrable in the oral cavity, and to provide the pharmaceutical preparation having the composition.

SOLUTION: The molded composition quickly disintegrable in the oral cavity is provided, comprising an excipient consisting of sugar alcohol(s); a hardly water-soluble disintegrant; and a lubricant. Such a method that the disintegration time of the composition in the oral cavity of an able-bodied adult is put within 30 s is also provided, including using, in the composition, such a lubricant as to be 3.0×10-3g2/s or higher in the infiltration rate of ethanol. In the composition, it is preferable that the sugar alcohol is mannitol and/or erythritol; the disintegrant is selected from the group consisting of hydroxypropyl starch, low-substitution-degree hydroxypropyl cellulose, crystalline cellulose, hydroxypropyl starch, and the like; and the lubricant is selected from the group consisting of leucine, sodium stearyl fumarate, talc and stearic acid.

COPYRIGHT: (C)2012,JPO&INPIT