Chewable soft capsules

摘要

A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier, and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

主权项

1. A chewable soft capsule comprising a sheath encapsulating a flowable matrix:
the sheath comprising:
a first gel-forming composition comprising gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, carbohydrates, carbopolymers, polysaccharides, starch, modified starch, alginates, hydroxypropylmethyl cellulose, methyl cellulose, or a combination thereof;a first plasticizer;a first polymer modifier;water; and the flowable matrix comprising:
a second gel-forming composition comprising gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, carbohydrates, carbopolymers, polysaccharides, starch, modified starch, alginates, hydroxypropylmethyl cellulose, methyl cellulose, or a combination thereof;a second plasticizer;a second polymer modifier;at least one active pharmaceutical ingredient;and water; wherein the first and second polymer modifiers comprise at least one of lactic acid, fumaric acid, tartaric acid, citric acid, glycolic acid, salts thereof, or combinations thereof.