High strength seamless alginate capsules

1. A seamless alginate capsule comprising a film encapsulating a fill material, wherein the film comprises alginate, glycerol, and a noncrystallizing plasticizer, wherein: (i) a weight ratio of the noncrystallizing plasticizer to glycerol is between about 1:1 and about 8:1; (ii) the total weight of plasticizer in said film is from 35-70% by weight of the film; and (iii) said capsule has a disintegration time of less than 12 minutes in an intestinal buffer after pretreatment for 20 minutes in a solution of 0.1 M NaCl and acid (HCl) at pH of 3 at 37° C.

2. The capsule of claim 1 , wherein the ratio is between about 2:1 and about 6:1.

3. The capsule of claim 1 , wherein the ratio is about 3:1.

4. The capsule of claim 1 , wherein the glycerol comprises between about 6% (wt/wt) and about 22% (wt/wt) of the film or the noncrystallizing plasticizer comprises between about 28% (wt/wt) and about 46% (wt/wt) of the film.

5. The capsule of claim 1 , wherein the glycerol comprises less than about 18% of the film by weight.

6. The capsule of claim 1 , wherein the glycerol comprises less than 16% of the film by weight.

7. The capsule of claim 1 , wherein the glycerol is about 14% of the film by weight.

8. The capsule of claim 4 , wherein the noncrystallizing plasticizer is noncrystallizing sorbitol.

9. The capsule of claim 8 , wherein the noncrystallizing sorbitol is about 36% of the film weight.

10. The capsule of claim 1 , wherein the film has a dry matter content of greater than 80% by weight.

11. The capsule of claim 1 , wherein the alginate comprises M alginate and G alginate, wherein the M alginate is between about 50% and about 62% by weight of M and G alginate.

12. The capsule of claim 1 , wherein the fill material comprises at least one unsaturated oil.

13. The capsule of claim 12 , wherein the fill material in the capsule has an oxidation rate of less than 8 TOTOX units increase per two weeks stored in open containers at 25° C./60% RH.

14. The capsule of claim 12 , wherein the fill material is at least 50% (wt/wt) oil.

15. The capsule of claim 12 , wherein the fill material further comprises a pharmaceutical, nutraceutical, or veterinary active agent, or a carrier therefor.

16. The capsule of claim 12 , wherein the oil comprises ω-3 fatty acids, triglycerides, or salts or esters thereof.

17. A seamless alginate capsule prepared by:

a) obtaining or preparing an emulsion comprising oil, water, optionally an emulsifier, and at least one of a water-soluble a polyvalent metal salt, and an acid, wherein the oil is present in an amount of at least 50% by weight of the emulsion;

b) dividing the emulsion into portions;

c) adding at least one portion of the emulsion to an aqueous gelling solution comprising alginate to form at least one wet capsule;

d) washing the at least one wet capsule with a wash solution to form at least one washed wet capsule;

e) contacting the at least one washed wet capsule with a plasticizing solution comprising (i) between about 2% (wt/wt) and about 18% (wt/wt) noncrystallizing sorbitol, and (ii) between about 6% (wt/wt) and about 3% (wt/wt) glycerol to form at least one plasticized wet capsule; and

drying the at least one plasticized wet capsule, wherein: (i) the total weight of plasticizer in said film is from 35-70% by weight of the film; and (ii) said capsule has a disintegration time of less than 12 minutes in an intestinal buffer after pretreatment for 20 minutes in a solution of 0.1 M NaCl and acid (HCl) at pH of 3 at 37° C.

18. The capsule of claim 17 , wherein the fill material comprises a pharmaceutical, nutraceutical, or veterinary active agent, or a carrier therefor.

19. The capsule of claim 1 , wherein said capsule has a dry break strength of at least 20 kg.

20. The capsule of claim 12 , wherein said pharmaceutical, nutraceutical, or veterinary agent is dispersed in said oil.

21. The capsule of claim 16 , wherein said pharmaceutical, nutraceutical, or veterinary agent is dissolved in said oil.