Oral solid preparation comprising aripiprazole and method for producing oral solid preparation comprising aripiprazole

Abstract

[Object] An object of the present invention is to provide an oral solid preparation that can be produced in a simpler manner than conventional methods, that exhibits high bioavailability and high dissolubility even in persons having low stomach acid, and that can also ensure dissolubility after being allowed to stand for a certain period of time. Another object is to provide a simple method for producing the oral solid preparation. [Means for Achieving the Object] The present invention relates to an oral solid preparation comprising, as an active ingredient, a finely milled crystal obtained by milling an aripiprazole hydrate crystal, and a pharmaceutically acceptable carrier, the finely milled crystal having a mean particle size of 15 μm or less; and a method for producing an oral solid preparation comprising the steps of (1) milling an aripiprazole hydrate crystal into a finely milled crystal having a mean particle size of 15 μm or less, and (2) mixing the obtained finely milled crystal with a pharmaceutically acceptable carrier.

1 . An oral solid preparation comprising, as an active ingredient, a finely milled crystal obtained by milling an aripiprazole hydrate crystal, and a pharmaceutically acceptable carrier, the finely milled crystal having a mean particle size of 15 μm or less. 
     
     
         2 . The oral solid preparation according to  claim 1 , wherein the finely milled crystal has a mean particle size of 14 μm or less. 
     
     
         3 . The oral solid preparation according to  claim 1 , wherein the finely milled crystal has a mean particle size of 10 μm or less. 
     
     
         4 . The oral solid preparation according to  claim 1 , wherein the finely milled crystal has a mean particle size of 5 μm or less. 
     
     
         5 . The oral solid preparation according to any one of  claims 1  to  4 , wherein the finely milled crystal has a mean particle size of 1 μm or more. 
     
     
         6 . A method for producing an oral solid preparation comprising the steps of:
 (1) milling an aripiprazole hydrate crystal into a finely milled crystal having a mean particle size of 15 μm or less; and   (2) mixing the obtained finely milled crystal with a pharmaceutically acceptable carrier.   
     
     
         7 . The method for producing an oral solid preparation according to  claim 6 , wherein the oral solid preparation is a tablet, and the method further comprises the step of (3) compressing the mixture obtained in step (2) into tablets.