Chewable soft capsules
View Patent ↗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.
1. A soft capsule suitable for chewing or buccal dissolution comprising a sheath encapsulating a flowable matrix,
the sheath comprising:
at least one gel-forming polymer;
at least one plasticizer;
at least one first sweetener;
at least one polymer modifier;
water; and
the flowable matrix comprising:
at least one hydrophilic polymer;
at least one flavoring agent;
at least one second sweetener;
at least one cold remedy; 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 a carboxylic acid.
5. 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.
6. The soft capsule of claim 1 , wherein the polymer modifier comprises citric acid.
7. The soft capsule of claim 1 , wherein the cold remedy comprises a decongestant, a cough suppressant, or a non-steroidal anti-inflammatory drug.
8. The soft capsule of claim 1 , wherein the sheath comprises:
about 32% of at least one gel-forming polymer;
about 40% of at least one plasticizer;
about 0.2% of at least one sweetener;
about 0.5% of at least one polymer modifier; and
about 23% water; and
the flowable matrix comprises:
about 5% water; and
about 1.5% of at least one cold remedy.
9. A soft capsule suitable for chewing or buccal dissolution comprising a sheath encapsulating a flowable matrix,
the sheath comprising:
at least one gel-forming polymer;
at least one plasticizer;
at least one first sweetener;
at least one first polymer modifier;
at least one colorant; and
water; and
the flowable matrix comprising:
at least one hydrophilic polymer;
at least one second polymer modifier;
at least one second sweetener;
at least one taste masking agent;
water; and
at least one non-steroidal anti-inflammatory drug.
10. The soft capsule of claim 8 , wherein the gel-forming polymer comprises gelatin, partially hydrolyzed gelatin, hydrolyzed gelatin, or a combination thereof.
11. The soft capsule of claim 8 , wherein the plasticizer comprises maltitol, glycerin, xylitol or a combination thereof.
12. The soft capsule of claim 8 , wherein the first and second polymer modifiers comprise a carboxylic acid.
13. The soft capsule of claim 8 , wherein the first and second polymer modifier comprises citric acid, lactic acid, tartaric acid, fumaric acid, glycolic acid, or a combination thereof.
14. The soft capsule of claim 8 , wherein the first and second polymer modifier comprises citric acid.
15. The soft capsule of claim 8 , wherein the second sweetener comprises sucralose.
16. The soft capsule of claim 8 , wherein the non-steroidal anti-inflammatory drug comprises ibuprofen.
17. The soft capsule of claim 8 , wherein the flowable matrix comprises:
about 2% polymer modifier;
about 20% water;
about 7% non-steroidal anti-inflammatory drug.
18. The soft capsule of claim 8 , wherein the capsule comprises:
about 15% total polymer;
about 10% total plasticizer;
about 2% total polymer modifier;
about 20% total water; and
about 7% non-steroidal anti-inflammatory drug.