Non-gelatin enteric soft capsules

1. An oral enteric dosage form comprising soft capsule shell and a fill,

the shell comprising:

2.5% iota carrageenan by mass;

0.6% kappa carrageenan by mass;

9.2% hydroxypropyl starch phosphate by mass;

2.4% polyvinyl alcohol-poly ethylene glycol graft copolymer by mass;

6.3% glycerin by mass;

2.9% dehydrated liquid sorbitol by mass;

1.7% ammonium hydroxide (30% w/v) by mass;

9.7% methacrylic acid copolymer by mass;

1.2% triethyl citrate by mass; and

63.4% water by mass; and

the fill comprising:

one or more active ingredients; and

optionally, one or more pharmaceutically acceptable excipients;

wherein the capsule shell is stable at pH 1.2 for at least 2 hours and dissolves at pH 6.8 within 30 minutes.

2. The dosage form of claim 1 , wherein the capsule shell is clear or transparent.

3. The dosage form of claim 1 , wherein the capsule shell is transparent and colored.

4. The dosage form of claim 1 , wherein the capsule shell has a thickness from about 0.010 inches to about 0.050 inches.

5. The dosage form of claim 1 , wherein the fill is liquid, semi-solid, or solid.

6. The dosage form of claim 1 , wherein the active ingredient comprises pharmaceutical agents, nutraceuticals, vitamins, minerals, or combinations thereof.

7. A method for preparing the enteric soft capsule of claim 1 , the method comprising:

(a) combining iota carrageenan, kappa carrageenan, hydroxypropyl starch phosphate, and methacrylic acid copolymer, together to form a dry mixture;

(b) adding glycerin, sorbitol, polyvinyl alcohol-poly ethylene glycol graft copolymer, ammonium hydroxide, triethyl citrate, and water to the dry mixture with agitation to form a wet mixture;

(c) heating the wet mixture with agitation and applying vacuum to form a gel mass;

(d) heating the gel mass for an additional period;

(i) transferring the heated gel mass to an extruder;

(ii) extruding the gel mass to form ribbons or films; and

(iii) forming an enteric soft capsule using rotary die technology comprising a fill; and

(e) drying the enteric soft capsule.

8. An enteric soft capsule comprising a fill formed by the method of claim 7 .