ALL-NATURAL ENTERIC SOFT CAPSULES

• US 20170119711A1
• Filed: 01/12/2017
• Published: 05/04/2017
• Est. Priority Date: 06/23/2014
• Status: Active Grant

• Current Assignee: Patheon Softgels, Inc. (Thermo Fisher Scientific Incorporated)
• Original Assignee: Banner Life Sciences, LLC (Thermo Fisher Scientific Incorporated)
• Inventors: Hu, Yunhua, Piest, Martin, Fang, Qi, van Duijnhoven, Henricus
• Granted Patent: US 9,782,374 B2
• Time in Patent Office: Days
• CPC Class Codes: A23L 29/284 Gelatin; Collagen
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23P 10/30 Encapsulation of particles, e.g. foodstuff additives
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 35/60 Fish, e.g. seahorses; Fish eggs
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61K 9/485 Inorganic compounds
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61K 9/4875 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/4858

Abstract

Described herein are soft capsules and enteric soft capsules comprising cationic Type A gelatin and acid insoluble enteric polymers. In particular, the compositions and methods for manufacturing all-natural enteric soft capsules comprising Type A gelatin and matrix fills are described. In one embodiment, the enteric soft capsules comprise active ingredients such as non-steroidal anti-inflammatory drugs (NSAIDs). In another embodiment, the enteric soft capsule comprises matrix fills of omega-3 fatty acids.

Claims

1. An enteric soft capsule gel mass composition comprising:

(a) about 20% to about 40% Type A gelatin by mass;

(b) about 2% to about 7% pectin by mass;

(c) about 8% to about 30% glycerol by mass;

(d) about 40% to about 70% water by mass; and

the composition does not contain a gelling agent such as calcium or magnesium.

2. The composition of claim 1, wherein upon extrusion to a ribbon, the ribbon comprises a strength of about 1.5 kg to about 2.5 kg.

3. The composition of claim 1, wherein the viscosity of the gel mass composition comprises about 20,000 cP to about 30,000 cP.

4. The composition of claim 1, wherein the Type A gelatin has a Bloom strength of about 150 grams to about 350 grams.

5. The composition of claim 1, wherein the Type A gelatin comprises acid bone gelatin.

6. The composition of claim 1, wherein the ribbon comprises a thickness of about 0.03 inches to about 0.045 inches.

7. The composition of claim 1, wherein the composition consists of

(a) about 33% to about 36% Type A gelatin by mass;

(b) about 3.3% pectin by mass;

(c) about 16% glycerol by mass; and

(d) about 44 to about 47% water by mass; and

the composition does not contain a gelling agent.

8. A method for preparing an enteric soft capsule consisting of

(a) about 20% to about 40% Type A gelatin by mass;

(b) about 2% to about 7% pectin by mass;

(c) about 8% to about 30% glycerol by mass;

(d) about 40% to about 70% water by mass; and

the composition does not contain a gelling agent;

the method comprising;

(i) combining the gelatin, pectin, glycerol and water with heating to form a gel mass; and

(ii) forming an enteric soft capsule from the gel mass using rotary die technology.

9. The enteric soft capsule formed by the method of claim 8.

10. The capsule of claim 9, wherein the capsule shell does not dissolve in simulated gastric fluid (pH 1.2) for at least 2 hours, and begins dissolution in simulated intestinal fluid (pH 6.8) within about 10 minutes.

11. The capsule of claim 9, wherein the capsule comprises a fill comprising one or more active ingredients.

12. The capsule of claim 9, wherein the capsule comprises a fill of fish oil or non-steroidal anti-inflammatory drug.

13. An enteric soft capsule comprising a shell and a matrix, the shell consisting of:

(a) about 20% to about 40% Type A gelatin by mass;

(b) about 2% to about 7% pectin by mass;

(c) about 8% to about 30% glycerol by mass; and

(d) about 40% to about 70% water by mass;

wherein the shell composition does not contain a gelling agent.

14. The capsule of claim 13, wherein the capsule shell comprises a strength of about 1.5 kg to about 2.5 kg.

15. The capsule of claim 13, wherein the matrix comprises one or more active ingredients.

16. The capsule of claim 13, wherein the active ingredient comprises fish oil or on a non-steroidal anti-inflammatory drug.

17. The capsule of claim 15, where in the fish oil comprises eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and one or more fat-soluble vitamins.

18. The capsule of claim 15, wherein the non-steroidal anti-inflammatory drug comprises diclofenac.