Chewable soft capsules
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 organoleptic 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.
1. A soft capsule suitable for chewing or buccal dissolution comprising
a sheath encapsulating a matrix,
the sheath comprising:
one or more gel-forming polymers;
one or more plasticizers;
one or more polymer modifiers comprising a carboxylic acid; and
water; and
the matrix comprising:
one or more second gel-forming polymers;
one or more non-steroidal anti-inflammatory drugs (NSAIDs); and
water.
2. The soft capsule of claim 1 , wherein the gel-forming polymer comprises gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, or a combination thereof.
3. The soft capsule of claim 1 , wherein the plasticizer comprises maltitol, glycerin, xylitol, or a combination thereof.
4. The soft capsule of claim 1 , wherein the polymer modifier comprises citric acid, lactic acid, tartaric acid, fumaric acid, glycolic acid, or a combination thereof.
5. The soft capsule of claim 1 , wherein the polymer modifier comprises citric acid.
6. The soft capsule of claim 1 , wherein the second gel-forming polymer comprises gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, or a combination thereof.
7. The soft capsule of claim 1 , wherein non-steroidal anti-inflammatory drug comprises ibuprofen, naproxen, celecoxib, or aspirin.
8. The soft capsule of claim 1 , wherein the shell further comprises one or more of sweeteners, flavors, or colors.
9. The soft capsule of claim 1 , wherein the matrix further comprises one or more of sweeteners or flavors.
10. A soft capsule suitable for chewing or buccal dissolution comprising
a sheath encapsulating a matrix,
the sheath comprising:
one or more gel-forming polymers;
one or more plasticizers;
one or more polymer modifiers comprising a carboxylic acid; and
water; and
the matrix comprising:
one or more second gel-forming polymers;
ibuprofen; and
water.
11. The soft capsule of claim 10 , wherein the gel-forming polymer comprises gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, or a combination thereof.
12. The soft capsule of claim 10 , wherein the plasticizer comprises maltitol, glycerin, xylitol, or a combination thereof.
13. The soft capsule of claim 10 , wherein the polymer modifier comprises citric acid, lactic acid, tartaric acid, fumaric acid, glycolic acid, or a combination thereof.
14. The soft capsule of claim 10 , wherein the polymer modifier comprises citric acid.
15. The soft capsule of claim 10 , wherein the second gel-forming polymer comprises gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, or a combination thereof.
16. The soft capsule of claim 10 , wherein the shell further comprises one or more of sweeteners, flavors, or colors.
17. The soft capsule of claim 10 , wherein the matrix further comprises one or more of sweeteners or flavors.
18. A soft capsule suitable for chewing or buccal dissolution comprising
a sheath encapsulating a matrix,
the sheath comprising:
one or more gel-forming polymers;
one or more plasticizer;
one or more polymer modifiers comprising a carboxylic acid;
one or more sweeteners;
one or more flavors;
one or more colors; and
water; and
the matrix comprising:
one or more second gel-forming polymers;
one or more sweeteners;
one or more flavors;
ibuprofen; and
water.