Bulk enteric capsule shells

Abstract

The present disclosure relates to aqueous composition comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water, wherein the dispersed polymer is partially neutralized with at least one alkaline material. The instant disclosure also relates to compositions for use in methods of making capsule shells endowed with bulk enteric properties. The present disclosure also relates to capsules made according with the compositions and methods of the present disclosure.

1 . An aqueous composition comprising:
 hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water; and   a film-forming aid, wherein the dispersed polymer is partially neutralized with at least one alkaline material.   
     
     
         2 . The composition according to  claim 1 , wherein a weight ratio of the HPMCAS polymer to the film-forming aid is from 1.5 to 3.5. 
     
     
         3 . The composition according to  claim 1 , wherein the amount of the polymer ranges from about 15% to about 25% by weight based on the total weight of the aqueous composition. 
     
     
         4 . The composition according to  claim 1 , wherein the amount of the at least one alkaline material is less than about 1.5% by weight of KOH equivalent based on the total weight of the aqueous composition. 
     
     
         5 . The composition according to  claim 1 , wherein the at least one alkaline material is selected from the group consisting of ammonia, sodium hydroxide, calcium hydroxide, potassium hydroxide, cationic polymers, and mixtures thereof. 
     
     
         6 . The composition according to  claim 1 , wherein the film-forming aid is hydroxypropyl methylcellulose (HPMC). 
     
     
         7 . The composition according to  claim 2 , wherein the weight ratio of the enteric polymer to the film-forming aid is from 2 to 2.5. 
     
     
         8 . The composition according to  claim 1 , wherein the at least one alkaline material is ammonia. 
     
     
         9 . The composition according to  claim 1 , wherein the film-forming aid is hydroxypropyl methylcellulose (HPMC), methylcellulose (MC), gellan gum, carrageenan, or a mixture thereof. 
     
     
         10 . The composition according to  claim 1 , wherein the aqueous composition is partially neutralized to a pH from 4 to 5.5. 
     
     
         11 . The composition according to  claim 1 , further comprising carrageenan and/or gellan gum. 
     
     
         12 . The composition according to  claim 1 , wherein the film forming aid comprises a thermogelling agent that undergoes a thermal gelation at elevated temperature. 
     
     
         13 .- 15 . (canceled) 
     
     
         16 . The composition according to  claim 1 , wherein the film forming aid is a plasticizer, surfactant, or a mixture thereof. 
     
     
         17 . (canceled) 
     
     
         18 . The composition according to  claim 1 , further comprising at least one pharmaceutically acceptable and/or food acceptable coloring agent.