| 摘要 |
The present invention provides an orally-disintegrating solid preparation comprising fine granules showing controlled release of a pharmaceutically active ingredient, which has a coating layer comprising methacrylic acid - methyl acrylate - methyl methacrylate copolymer which has a casting film having an elongation at break of about 100 percent - about 700 percent, wherein the pharmaceutically active ingredient dissolved from the fine granules showing controlled release of the pharmaceutically active ingredient is not more than 10 percent in 2 hours as expressed by the dissolution rate in a pH 1.2 solution, and not more than 5 percent in 1 hour as expressed by the dissolution rate in a pH 6.8 solution, and wherein the fine granules have an average particle size of about 500 im (micometers or microns) or below. Also disclosed is a solid preparation comprising two different fine granules with different release rates which have a coating layer of methacrylic acid - methyl acrylate - methyl methacrylate copolymer. Further disclosed is a method for supressing breakages of fine granules showing controlled release of a pharmaceutically active ingredient which are comprised in an orally-disintegrating tablet obtained by tableting the fine granules and an additive, which method comprises, during production of the tablet, coating the fine granules with a coating layer comprising a methacrylic acid - methyl acrylate - methyl methacrylate copolymer, which has a casting film having an elongation at break of about 100 - about 700 percent. |
