Disintegrating particle composition produced by two-stage wet granulation process, and intraorally disintegrating tablet containing same composition

Abstract

A method is used in the production of a disintegrative particulate composition including three components consisting of a first disintegrator component having sedimentation volume in water of 4.0 cm3/g or more, and a second disintegrator component other than the first disintegrator component and an excipient. The method includes a first wet granulation step using any two of the three components, and a second wet granulation step using the granules obtained in the first wet granulation step and at least the component not used in the first wet granulation step; thus the disintegrative particulate composition is produced. Moreover, an orally disintegrating tablet contains a medicinal ingredient and the disintegrative particulate composition.

1 - 7 . (canceled) 
     
     
         8 . A disintegrative particulate composition including three components consisting of (1) a first disintegrator component having sedimentation volume in water of 4.0 cm 3 /g or more, (2) a second disintegrator component other than the first disintegrator component, wherein the second disintegrator component is not an acid-type carboxymethylcellulose, and (3) an excipient component, said disintegrative particulate composition is produced by a method comprising:
 a first wet granulation step using any two of the three components; and   a second wet granulation step using at least the granules obtained in the first wet granulation step and the other one of the three components which is not used in the first wet granulation step,   wherein the first disintegrator component is crospovidone, croscarmellose sodium, carboxymethyl starch sodium, carboxymethylcellulose calcium, or alpha-starch or partially alpha-starch.   
     
     
         9 . The disintegrative particulate composition of  claim 8 , wherein the first disintegrator component is crospovidone. 
     
     
         10 . A disintegrative particulate composition including three components consisting of (1) a first disintegrator component having sedimentation volume in water of 4.0 cm 3 /g or more, (2) a second disintegrator component other than the first disintegrator component, wherein the second disintegrator component is not an acid-type carboxylmethylcellulose, and (3) an excipient component, said disintegrative particulate composition is produced by a method comprising:
 a first wet granulation step using any two of the three components; and   a second wet granulation step using at least the granules obtained in the first wet granulation step and the other one of the three components which is not used in the first wet granulation step,   wherein the second disintegrator components are one or more of non-alpha-starch, corn starch, processed starch, hydroxypropyl starch and low substituted hydroxypropylcellulose.   
     
     
         11 . A disintegrative particulate composition including three components consisting of (1) a first disintegrator component having sedimentation volume in water of 4.0 cm 3 /g or more, (2) a second disintegrator component other than the first disintegrator component, wherein the second disintegrator component is not an acid-type carboxylmethylcellulose, and (3) an excipient component, said disintegrative particulate composition is produced by a method comprising
 a first wet granulation step using any two of the three components; and   a second wet granulation step using at least the granules obtained in the first wet granulation step and the other one of the three components which is not used in the first wet granulation step,   wherein crystalline cellulose is used as a fourth component in the first wet granulation step and/or the second wet granulation step.