Photostabilized soft capsule

Abstract

An object of the present invention is to provide a small-sized light-stabilized soft capsule formulation, which has a shell that ensures effective light-shielding of an active ingredient encapsulated thereby. The present invention provides a light-stabilized soft capsule formulation comprising a shell containing a non-water-soluble light-shielding agent and having an average thickness of 200 μm or less, and a medicament encapsulated by the shell.

1 . A light-stabilized soft capsule formulation comprising: 
 a shell containing a non-water-soluble light-shielding agent and having an average thickness of 200 μm or less; and    a medicament encapsulated by said shell.    
     
     
         2 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the amount of the non-water-soluble light-shielding agent is 5 to 30 wt %, based on the total amount of all components constituting the shell.  
     
     
         3 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the non-water-soluble light-shielding agent is titanium oxide.  
     
     
         4 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the soft capsule formulation has an average capsule size of 2 mm or less.  
     
     
         5 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the shell is seamless.  
     
     
         6 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the medicament is a light-unstable substance.  
     
     
         7 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the medicament is in a liquid form or the medicament is dissolved or suspended in a liquid base.  
     
     
         8 . The light-stabilized soft capsule formulation according to  claim 7 , wherein the medicament is a vitamin D derivative.  
     
     
         9 . The light-stabilized soft capsule formulation according to  claim 1 , wherein the major component of the shell is gelatin.  
     
     
         10 . A method for preparing a shell-forming solution which is used to form a soft capsule shell containing a non-water-soluble light-shielding agent, said method comprising the step of dispersing the non-water-soluble light-shielding agent in a medium free from a gelling agent.  
     
     
         11 . A method for manufacturing a soft capsule formulation containing a non-water-soluble light-shielding agent in its shell, comprising:  
       (i) the step of preparing a shell-forming solution, comprising the following steps (a) to (c): 
 (a) dissolving a gelling agent in Medium A;  
 (b) dispersing the non-water-soluble light-shielding agent in Medium B free from the gelling agent; and  
 (c) mixing Medium A containing the gelling agent dissolved therein with Medium B containing the non-water-soluble light-shielding agent dispersed therein; and  
 (ii) the step of forming a capsule shell for the soft capsule formulation using the shell-forming solution prepared in the step (i).  
 
     
     
         12 . The method for manufacturing a soft capsule formulation according to  claim 11 , wherein the step of forming a capsule shell for the soft capsule formulation is accomplished by the in-liquid curing coating method.  
     
     
         13 . The light-stabilized soft capsule formulation comprising: 
 a shell containing a non-water-soluble light shielding agent and having an average thickness of 200 m or less; and    a medicament encapsulated by said shell, which is manufactured by the method according to  claim 11 .    
     
     
         14 . A unit dose package comprising the light-stabilized soft capsule formulation according to  claim 1 .  
     
     
         15 . A hard capsule, a tablet, an oral solution or an external preparation, which is prepared using the light-stabilized soft capsule formulation according to  claim 1.