# US 2014/0154311 A1 · Enteric Soft Capsules > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154311 A1 - Document ID: US20140154311A1 - Status: Published application - Kind: A1 - Application number: 13/693,332 - Filed: 2012-12-04 - Published: 2014-06-05 - Earliest claimed: 2012-12-04 - Assignees: Banner Pharmacaps, Inc. - Applicants: Banner Pharmacaps, Inc. - Inventors: Emadeldin M. Hassan; Aqeel A. Fatmi; Nachiappan Chidambaram - Web page: https://patentgrep.com/patent/US20140154311A1 ## CPC - A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)} - A23L 29/284: {Gelatin; Collagen} - A23P 10/30: Encapsulation of particles, e.g. foodstuff additives - A61K 9/4816: {Wall or shell material} - A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)} - A61K 9/4858: {Organic compounds} - A61K 9/4866: {Organic macromolecular compounds} - A61K 9/70: Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)} - A61K 31/4402: only substituted in position 2, e.g. pheniramine, bisacodyl - A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) - A61K 31/5415: ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam - A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid - A61K 31/663: Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid - A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS - A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION ## Abstract A gel mass is provided that is useful in manufacturing enteric soft or hard capsules, or enteric tablets without coating. ## Claims ### Claim 1 An enteric soft capsule shell formed from a gel mass comprising: (a) a gelatin, (b) an acid-insoluble polymer; and (c) an alkaline aqueous solvent; wherein the gelatin and acid-insoluble polymer together comprise 45% by weight of the gel mass; the ratio of acid-insoluble polymer to gelatin is from 30:70 to 45:55 by weight; the final pH of the gel mass is less than or equal to about 9 pH units; and the final moisture content of the enteric soft capsule shell formed from the gel mass composition is from about 2% to about 10%. ### Claim 2 (depends on 1) The enteric soft capsule shell of claim 1, wherein the gelatin comprises at least about 25% by weight of the gel mass. ### Claim 3 (depends on 1) The enteric soft capsule shell of claim 1, wherein gelatin comprises about 25% to about 36% by weight of the gel mass. ### Claim 4 (depends on 1) The enteric soft capsule shell of claim 1, wherein the acid-insoluble polymer comprises at most about 20% by weight of the gel mass. ### Claim 5 (depends on 1) The enteric soft capsule shell of claim 1, wherein the acid-insoluble polymer comprises about 8% to about 20% by weight of the gel mass. ### Claim 6 (depends on 1) The enteric soft capsule shell of claim 1, wherein the gelatin is extracted from animal bones or skins, and has a bloom value of about 100 to about 250. ### Claim 7 (depends on 1) The enteric soft capsule shell of claim 1, wherein the acid-insoluble polymer is selected from the group consisting of acrylic and methacrylic acid copolymers, cellulose acetate esters such as phthalate, butyrate, hydroxypropyl methylcellulose phthalate, and salts thereof. ### Claim 8 (depends on 7) The enteric soft capsule shell of claim 7, wherein the acid-insoluble polymer is methacrylic acid copolymers. ### Claim 9 (depends on 1) The enteric soft capsule shell of claim 1, further comprising at least one plasticizer selected from the group consisting of sorbitol, glycerol, polyethylene glycol, poly-alcohols with 3 to 6 carbon atoms, citric acid, citric acid esters, triethyl citrate, and combinations thereof. ### Claim 10 (depends on 1) The enteric soft capsule shell of claim 1, wherein the alkaline aqueous solvent comprises an alkali selected from the group consisting of ammonia, sodium hydroxide, potassium hydroxide, ethylenediamine, hydroxylamine, and tri-ethanolamine. ### Claim 11 (depends on 1) The enteric soft capsule shell of claim 1, wherein the alkaline aqueous solvent comprises a volatile alkali. ### Claim 12 (depends on 11) The enteric soft capsule shell of claim 11, wherein the volatile alkali is selected from the group consisting of ammonia and ethylenediamine. ### Claim 13 (depends on 1) The enteric soft capsule shell of claim 1, wherein the alkaline aqueous solvent is a hydroalcoholic solution. ### Claim 14 (depends on 1) The enteric soft capsule shell of claim 1, where the final pH of the gel mass is less than or equal to about 8.5. ### Claim 15 (depends on 1) The enteric soft capsule shell of claim 1, wherein the gel mass has a moisture content of from about 9% to about 35%. ### Claim 16 (depends on 1) The enteric soft capsule shell of claim 1, wherein the final moisture content of the enteric soft capsule shell formed from the gel mass composition is from about 4% to about 8%. ### Claim 17 (depends on 1) The enteric soft capsule shell of claim 1, wherein the gel mass compositions comprises a plasticizer, and the ratio of plasticizer to film-forming, water-soluble polymer is from about 1:9 to about 1:1 by weight. ### Claim 18 (depends on 17) The enteric soft capsule shell of claim 17, wherein the ratio of plasticizer to film-forming, water-soluble polymer is about 1:3 by weight. ### Claim 19 (depends on 1) The enteric soft capsule shell of claim 1, wherein the plasticizer comprises about 17% of the gel mass. ### Claim 20 (depends on 1) The enteric soft capsule shell of claim 1, wherein the thickness of the capsule shell is from about 0.015 inches to about 0.050 inches. ### Claim 21 (depends on 1) A process of manufacturing enteric soft capsules, the process comprising (a) preparing a gel mass of claim 1; (b) casting the gel mass into films using heat-controlled drums or surfaces; and (c) forming a soft capsule using rotary die technology.