# US 11,998,641 B2 · Modified release coated capsules > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,641 B2 - Document ID: US11998641B2 - Status: Granted - Kind: B2 - Application number: 17/510,829 - Filed: 2021-10-26 - Published: 2022-02-17 - Granted: 2024-06-04 - Earliest claimed: 2014-05-19 - Assignees: Tillotts Pharma AG - Applicants: Tillotts Pharma AG - Inventors: Roberto Carlos Bravo Gonzaléz; Felipe José Oliveira Varum; Thomas Buser - Web page: https://patentgrep.com/patent/US11998641B2 ## CPC - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)} - A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)} - A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)} - A61K 9/4866: {Organic macromolecular compounds} - 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) ## Abstract Herein described is a modified release coated capsule and a process to obtain that capsule. ## Claims ### Claim 1 A capsule filled with a liquid material comprising a body, a cap and a gap therebetween, characterized in that said capsule body and capsule cap define a capsule shell, wherein capsule shell is selected from the group consisting of a hydroxypropylmethyl cellulose (HPMC) shell, a pullulan shell, and a polyvinyl alcohol (PVA)-based shell, and said capsule further comprises a band seal and a modified release coating applied to said capsule shell, further wherein said band seal is a gelatin band sealing the gap between said capsule body and capsule cap, and said modified release coating is an enteric coating that includes an enteric film forming agent, wherein the enteric film forming agent is present in an amount ranging from about 1 mg/cm2 to about 4.0 mg/cm2 of the modified release coating and is selected from the group consisting of acrylate polymers, cellulose polymers, polyvinyl-based polymers and mixtures thereof, further wherein there is no pre-coating between said capsule shell and said modified release coating, further wherein said enteric coating renders said capsule resistant against stomach acid while completely releasing its liquid material contents under intestinal tract conditions. ### Claim 2 (depends on 1) The capsule according to claim 1, wherein said enteric film forming agent is selected from the group consisting of co-polymers of (meth)acrylic acid and a (meth)acrylic acid C1-4 alkyl ester, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethyl cellulose acetate succinate, carboxymethylethyl cellulose acetate butyrate, polyvinyl acetate phthalate, and mixtures thereof. ### Claim 3 (depends on 1) The capsule according to claim 1, wherein said enteric film forming agent is an anionic poly(methacrylic acid/methyl methacrylate) co-polymer having a pH threshold of 5.5, 6.0 or 7. ### Claim 4 (depends on 1) The capsule according to claim 1, wherein the enteric film forming agent is present in an amount ranging from 1 mg/cm2 to 4.0 mg/cm2 of the modified release coating. ### Claim 5 (depends on 1) The capsule according to claim 1, wherein the modified release coating additionally comprises at least one excipient selected from the group consisting of plasticizers, anti-tacking agents, colourants, pigments, solubilizers, dispersion agents and surfactants. ### Claim 6 (depends on 1) The capsule according to claim 1, further comprising one or more additional coatings. ### Claim 7 (depends on 1) The capsule according to claim 1, wherein said liquid material comprises a nutritional ingredient and/or an active pharmaceutical ingredient. ### Claim 8 (depends on 1) The capsule according to claim 1, wherein the enteric film forming agent is present in an amount ranging from 1 mg/cm2 to 3.5 mg/cm2 of the modified release coating. ### Claim 9 (depends on 1) A process for manufacturing a liquid-filled capsule according to claim 1 comprised of a body, a cap and a gap therebetween, wherein said process comprises the steps of (i) filling the capsule body with a liquid material, (ii) closing the capsule with said cap, (iii) sealing the gap between body and cap with a gelatin band and (iv) applying a modified release coating onto the capsule shell, wherein the modified release coating is an enteric coating that includes an enteric film forming agent, wherein the enteric film forming agent is present in an amount ranging from about 1 mg/cm2 to about 4.0 mg/cm2 of the modified release coating and is selected from the group consisting of acrylate polymers, cellulose polymers, polyvinyl-based polymers and mixtures thereof, further wherein there is no pre-coating between said capsule shell and said modified release coating, further wherein said enteric coating renders said capsule resistant against stomach acid while completely releasing its liquid material contents under intestinal tract conditions. ### Claim 10 (depends on 9) The process according to claim 9, wherein the modified release coating is applied onto the capsule shell in the form of an aqueous or non-aqueous liquid composition that includes the enteric film forming agent.