Patent ID: 9029427
Filing Date: 2015-05-12
Classification: A61K

Abstract:
1. A solid preparation which comprises at least one active ingredient and at least one dissolution-controlling base substance and is obtained by compression molding, wherein the dissolution-controlling base substance contains a modified starch such that the solid preparation contains 5.0-99.9% by weight of the modified starch based on the total weight of the solid preparation, the modified starch having a moisture retaining capacity of 400% or more and a gel indentation load of 200 g or more, the modified starch containing a water-soluble ingredient in an amount of 40-95% by weight based on the total weight of the modified starch, the modified starch having particles passing through a 75 μm-mesh sieve in the proportion of 90% by weight or more and particles passing through a 32 μm-mesh sieve in the proportion of 20% by weight or more, having an average particle diameter of not smaller than 20 μm and smaller than 50 μm, the modified starch having an angle of repose of 45° or smaller, a specific volume of 1.4-3.6 cm 3 /g, and a swelling degree of 6-10 cm 3 /g, wherein a difference between a dissolution rate obtained from a dissolution test conducted using as a test solution the second solution specified in the Japanese pharmacopeia and a dissolution rate obtained from a dissolution test conducted using as a test solution the Mcilvaine solution is 7% or less, and wherein a difference between a dissolution rate obtained from a dissolution test on a solid preparation molded under a pressure of 120 MPa in compression molding and a dissolution rate obtained from a dissolution test on a solid preparation molded under a pressure of 300 MPa in compression molding is 7% or less.