Pharmaceutical composition

Abstract

Provided is a pharmaceutical composition which contains pemafibrate, a salt thereof or a solvate thereof and one or more selected from the group consisting of a metal oxide, a dihydric alcohol, an ester species and a silicic acid compound and which has excellent storage stability. The pharmaceutical composition includes the following components (A) and (B): (A) pemafibrate, a salt thereof or a solvate thereof; and (B) one or more selected from the group consisting of the following components (B-1) to (B-4): (B-1) a metal oxide; (B-2) a dihydric alcohol; (B-3) an ester species; and (B-4) a silicic acid compound, with component (A) and component (B) being substantially in non-contact with each other.

1 . A pharmaceutical composition comprising the following components (A) and (B):
 (A) pemafibrate, a salt thereof or a solvate thereof, and   (B) one or more selected from the group consisting of the following components (B-1) to (B-4):   (B-1) a metal oxide;   (B-2) a dihydric alcohol;   (B-3) an ester species; and   (B-4) a silicic acid compound,   
       wherein component (A) and component (B) are substantially in non-contact with each other. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is a solid preparation. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein a dosage form thereof is a tablet, a capsule, a granule, a powder or a pill. 
     
     
         4 . A pharmaceutical composition which is a film-coated tablet comprising a core tablet and a film coating layer, the core tablet containing the following component (A):
 (A) pemafibrate, a salt thereof or a solvate thereof,   
       the film coating layer containing one or more selected from the group consisting of the following components (B-1) to (B-4):
 (B-1) a metal oxide; 
 (B-2) a dihydric alcohol; 
 (B-3) an ester species; and 
 (B-4) a silicic acid compound. 
 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein component (B-1) is one or more selected from the group consisting of yellow oxide of iron, yellow ferric oxide, brown iron oxide, black iron oxide, synthetic hydrotalcite, zinc oxide, aluminum oxide, calcium oxide, titanium oxide, magnesium oxide and red ferric oxide. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein component (B-2) is one or more selected from the group consisting of ethylene glycol, propylene glycol, 1,3-propanediol, 2-methyl-1,3-propanediol, 1,3-butanediol, diethylene glycol, dipropylene glycol, macrogol, polypropylene glycol and polyoxyethylene polyoxypropylene glycol. 
     
     
         7 . The pharmaceutical composition according to  claim 1 , wherein component (B-3) is one or more selected from the group consisting of acetyltriethyl citrate, acetyltributyl citrate, triethyl citrate, tributyl citrate and triacetin. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein component (B-4) is one or more selected from the group consisting of magnesium aluminosilicate, calcium silicate, magnesium silicate, aluminum magnesium silicate, light anhydrous silicic acid and heavy anhydrous silicic acid. 
     
     
         9 . A method for stabilizing pemafibrate, a salt thereof or a solvate thereof in a pharmaceutical composition, the method comprising the step of incorporating the following components (A) and (B):
 (A) pemafibrate, a salt thereof or a solvate thereof; and   (B) one or more selected from the group consisting of the following components (B-1) to (B-4):   (B-1) a metal oxide;   (B-2) a dihydric alcohol;   (B-3) an ester species; and   (B-4) a silicic acid compound,   
       wherein component (A) and component (B) are substantially in non-contact with each other.