Acid resistant capsules
AssigneeCapsugel Belgium NV
InventorsXiongwei David He, Stefaan Jaak Vanquickenborne, Jonathan Leonard Cape, Dwayne Thomas Friesen
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Abstract
An acid resistant capsule comprises at least one hard capsule shell, said shell comprising: an enteric polymer having acid groups; a film-forming aid; and an alkaline material, wherein said alkaline material is present in an amount such that said carboxylic acid groups of said enteric polymer have a degree of ionization of less than 15%.
Claims20
An acid resistant capsule comprising at east one hard capsule shell, said shell comprising:
- at least one enteric polymer having acid groups;
- a film-forming aid;
- and
- an alkaline material, wherein said alkaline material is present in an amount such that said carboxylic acid groups of said enteric polymer have a degree of ionization of less than 15%.
An acid resistant capsule consisting essentially of:
- water present in an amount of from 1 wt % to 10 wt %;
- HPMCAS present in an amount of from 40 wt % to 90 wt %;
- a film-forming aid selected from the group consisting of HPMC and MC present in an amount of from 10 wt % to 50 wt %;
- and
- an alkaline material comprising ammonia and/or ethanolamine present in an amount of less than 1 wt %, wherein said alkaline material is present in an amount such that the carboxylic acid groups of said HPMCAS have a degree of ionization of less than 15%.
A dip-molding process for the manufacture of acid resistant hard capsule shells, the process comprising:
- a) providing an aqueous composition comprising an enteric polymer having acid groups, a film-forming aid, and an alkaline material, said alkaline material being present in a sufficient amount so that said enteric polymer is homogeneously dispersed in said aqueous composition;
- b) provided dipping mold pins in said aqueous composition;
- c) extracting said mold pins from said aqueous composition such that a film forms over each of said mold pins;
- d) drying said film to form a solid coating on each of said mold pins;
- e) removing said solid coating from said mold pins to provide capsule shells;
- and
- f) reducing the amount of said alkaline material from the capsule shells such that said acid groups of said enteric polymer in said capsule shells have a degree of ionization of less than 15%.
Dependencies are inferred from the claim text.