Granulated composite, rapid release tablet and method for producing same

Abstract

Provided is a rapid release tablet excellent in binding capability and disintegrability and also excellent in storage stability and the like. More specifically, provided are a granulated composite comprising low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight and D-mannitol, wherein the D-mannitol contains 0.9% by weight or less of D-sorbitol; a rapid release tablet comprising the granulated composite and a drug; and a method for producing a granulated composite comprising the steps of: mixing low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight, first D-mannitol, and water to obtain an aqueous dispersion, and granulating while adding the aqueous dispersion to second D-mannitol, wherein the first D-mannitol and the second D-mannitol contain 0.9% by weight or less of D-sorbitol in total.

1 . A granulated composite comprising low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight, and D-mannitol, wherein the D-mannitol contains 0.9% by weight or less of D-sorbitol. 
     
     
         2 . The granulated composite according to  claim 1 , further comprising polyvinyl alcohol. 
     
     
         3 . A rapid release tablet, comprising the granulated composite as claimed in  claim 1 , and a drug. 
     
     
         4 . A method for producing a granulated composite, comprising the steps of:
 mixing low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight, first D-mannitol, and water to obtain an aqueous dispersion, and   granulating while adding the aqueous dispersion to second D-mannitol, wherein the first D-mannitol and the second D-mannitol contain 0.9% by weight or less of D-sorbitol in total.   
     
     
         5 . The method for producing a granulated composite according to  claim 4 , wherein the step of mixing comprises mixing with polyvinyl alcohol. 
     
     
         6 . A method for producing a rapid release tablet, comprising:
 each step comprised by the method of  claim 4  to obtain the granulated composite,   a step of mixing the granulated composite with a drug to obtain a mixture, and   a step of tableting the mixture.   
     
     
         7 . A rapid release tablet, comprising the granulated composite as claimed in  claim 2 , and a drug. 
     
     
         8 . A method for producing a rapid release tablet, comprising:
 each step comprised by the method of  claim 5  to obtain the granulated composite,   a step of mixing the granulated composite with a drug to obtain a mixture, and   a step of tableting the mixture.