Enteric bisacodyl softgel capsule

Abstract

Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.

1 . A softgel capsule comprising:
 (a) a fill material; and   (b) a shell composition,
 wherein the fill material comprises bisacodyl or a pharmaceutically acceptable salt and 
 wherein the shell composition comprises a film forming material and an entire polymer. 
   
     
     
         2 . The softgel capsule of  claim 1 , wherein the film forming material comprises an animal derived polymer or a non-animal derived polymer. 
     
     
         3 . The softgel capsule of  claim 2 , wherein the animal derived polymer comprises gelatin, and the non-animal derived polymer comprises gellan gum. 
     
     
         4 . (canceled) 
     
     
         5 . The softgel capsule of  claim 1 , wherein the shell composition further comprises dextrose. 
     
     
         6 . The softgel capsule of  claim 1 , wherein the shell composition further comprises a plasticizer. 
     
     
         7 . The softgel capsule of  claim 1 , wherein the enteric polymer is pectin, or methyl acrylic acid copolymer. 
     
     
         8 . (canceled) 
     
     
         9 . The softgel capsule of  claim 7 , wherein the pectin is an amidated pectin or a non-amidated pectin or combinations thereof. 
     
     
         10 . The softgel capsule of  claim 3 , wherein the shell composition comprises about 30 wt % to about 80 wt % of a gelatin. 
     
     
         11 . The softgel capsule of  claim 7 , wherein the shell composition comprises about 2 wt % to about 20 wt % of pectin. 
     
     
         12 . The softgel capsule of  claim 7 , wherein the shell composition comprises about 2 wt % to about 16 wt % of methyl acrylic acid copolymer. 
     
     
         13 . The softgel capsule of  claim 5 , wherein the shell composition comprises about 0.01 wt % to about 4 wt % of dextrose. 
     
     
         14 . The softgel capsule of  claim 6 , wherein the shell composition comprises about 2 wt % to about 40 wt % of a plasticizer. 
     
     
         15 .- 23 . (canceled) 
     
     
         24 . The softgel capsule of  claim 1 , wherein the fill material further comprises an antioxidant. 
     
     
         25 . The softgel capsule of  claim 1 , wherein the fill material further comprises butylated hydroxytoluene (BHT), or butylated hydroxyanisole (BHA). 
     
     
         26 .- 31 . (canceled) 
     
     
         32 . The softgel capsule of  claim 1 , wherein the fill material comprises about 5 parts by weight to about 10 parts by weight of bisacodyl based on 100 parts by weight of the fill material. 
     
     
         33 . The softgel capsule of  claim 24 , wherein the fill material comprises about 0.001 parts by weight to about 2 parts by weight of antioxidant based on 100 parts by weight of the fill material. 
     
     
         34 . The softgel capsule of  claim 25 , wherein the fill material comprises about 0.001 parts by weight to about 0.5 parts by weight of BHT based on 100 parts by weight of the fill material. 
     
     
         35 . The softgel capsule of  claim 25 , wherein the fill material comprises about 0.1 parts by weight to about 2 parts by weight of BHA based on a 100 parts by weight of the fill material. 
     
     
         36 .- 65 . (canceled) 
     
     
         66 . The softgel capsule of  claim 1 , wherein the total impurity does not exceed about 0.5%, about 0.4%, about 0.3%, about 0.2%, about 0.1% or about 0.01%, wherein the total impurity is measured per current USP Monograph test method. 
     
     
         67 . (canceled) 
     
     
         68 . A process for producing the softgel capsule of  claim 1 , comprising encapsulating the fill composition in the shell composition to form the softgel capsule and drying the softgel capsule. 
     
     
         69 . (canceled)