Enteric soft capsule compositions
View Patent ↗Described herein are enteric soft capsules comprising gastric resistant polymers and gelatin and methods for manufacturing the same. The enteric soft capsules described herein have enhanced enteric and elastic properties and are simpler to manufacture and produce.
1. An oral enteric soft capsule shell formed from a gel mass composition comprising:
(a) about 10% to about 40% by mass of Type B gelatin;
(b) about 8% to about 12% by mass of an acid insoluble polymer comprising poly(methacylic acid-co-ethyl acrylate) 1:1; and
(c) about 8% to about 30% by mass of one or more plasticizers; and
wherein the composition comprises a mass ratio of gelatin to the acid-insoluble polymer of about 2.5:1 to about 3:1.
2. The composition of claim 1 , wherein the Type B gelatin comprises about 28% by mass.
3. The composition of claim 1 , wherein the Type B gelatin has a Bloom strength of about 130 grams to about 170 grams.
4. The composition of claim 1 , wherein the poly(methacylic acid-co-ethyl acrylate) 1:1 comprises about 11% by mass.
5. The composition of claim 1 wherein the one or more plasticizers comprise sorbitol, non-crystallizing sorbitol, corn syrup, maltitol, glycerol, polyethylene glycol, citric acid, citric acid esters, triethyl citrate, or combinations thereof.
6. The composition of claim 1 , wherein the one or more plasticizers comprise glycerol and triethyl citrate.
7. The composition of claim 1 , further comprising an alkali neutralizing agent comprising sodium hydroxide, potassium hydroxide, or ammonia.
8. The composition of claim 7 , wherein the alkali neutralizing agent comprises about 1% to about 7% by mass.
9. The composition of claim 1 , further comprising about 40% by mass water.
10. An oral enteric soft capsule shell formed from a gel mass composition comprising:
(a) about 10% to about 40% by mass of Type B gelatin;
(b) about 5% to about 20% of by mass of two acid-insoluble polymers comprising poly(methacylic acid-co-ethyl acrylate) 1:1 and poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1; and
(c) about 8% to about 30% by mass of one or more plasticizers; and
wherein the composition comprises a mass ratio of gelatin to acid-insoluble polymers of 2.5:1 to 3:1; and
a mass ratio of poly(methacylic acid-co-ethyl acrylate) 1:1 to poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1 of about 1:6 to about 5:1.
11. The composition of claim 10 , wherein the poly(methacylic acid-co-ethyl acrylate) 1:1 comprises about 11% by mass.
12. The composition of claim 10 , wherein the poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1 comprises about 0.25% by mass.
13. The composition of claim 10 , wherein the mass ratio of poly(methacylic acid-co-ethyl acrylate) 1:1 to poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1 is about 2:1 to about 3:1.
14. The composition of claim 10 , wherein the Type B gelatin comprises about 28% by mass.
15. The composition of claim 10 , wherein the Type B gelatin has a Bloom strength of about 130 grams to about 170 grams.
16. The composition of claim 10 , wherein the one or more plasticizers comprise sorbitol, non-crystallizing sorbitol, corn syrup, maltitol, glycerol, polyethylene glycol, citric acid, citric acid esters, triethyl citrate, or combinations thereof.
17. The composition of claim 10 , wherein the one or more plasticizers comprise glycerol and triethyl citrate.
18. The composition of claim 10 , further comprising an alkali neutralizing agent comprising sodium hydroxide, potassium hydroxide, or ammonia.
19. The composition of claim 18 , wherein the alkali neutralizing agent comprises about 1% to about 7% by mass.
20. The composition of claim 10 , further comprising about 40% by mass water.