# US 8,784,886 B2 · Coating capsules with active pharmaceutical ingredients > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,886 B2 - Document ID: US8784886B2 - Status: Granted - Kind: B2 - Application number: 11/716,020 - Filed: 2007-03-09 - Published: 2007-09-13 - Granted: 2014-07-22 - Earliest claimed: 2006-03-09 - Assignees: GlaxoSmithKline LLC - Applicants: Abdel Fawzy; George Bobotas - Inventors: Abdel Fawzy; George Bobotas - Web page: https://patentgrep.com/patent/US8784886B2 ## 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: 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 Pharmaceutical compositions in unit dose form comprising capsules containing one or more first active pharmaceutical ingredient in a pharmaceutically acceptable vehicle, coated with one or more second active pharmaceutical ingredients, wherein the unit dose form is a pharmaceutical grade finished dosage form, and methods of making and using the same. ## Claims ### Claim 1 A pharmaceutical composition in unit dose form comprising: (a) a soft gelatin capsule comprising a single, first active pharmaceutical ingredient (“API”), wherein the first API is an omega-3 fatty acid oil and is present in the form of a pharmaceutically acceptable vehicle; (b) one or more coatings on the capsule, wherein at least one coating comprises a second active pharmaceutical ingredient (“API”), wherein the second API is a statin compound and is the only API in the one or more coatings, and wherein the at least one coating comprising the second active pharmaceutical ingredient is applied by pan coating, fluid bed coating, or spray coating; and wherein the unit dose form is a pharmaceutical grade finished dosage form suitable for oral administration. ### Claim 2 (depends on 1) The pharmaceutical composition of claim 1, further comprising at least one additional coating between the capsule and the at least one coating comprising the second active pharmaceutical ingredient. ### Claim 3 (depends on 2) The pharmaceutical composition of claim 2, wherein the at least one additional coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, and combinations thereof. ### Claim 4 (depends on 1) The pharmaceutical composition of claim 1, further comprising at least one top coating on the at least one coating comprising the second active pharmaceutical ingredient. ### Claim 5 (depends on 4) The pharmaceutical composition of claim 4, wherein the at least one top coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, and combinations thereof. ### Claim 6 (depends on 1) The pharmaceutical composition of claim 1, further comprising at least one barrier coating between the capsule and the at least one coating comprising the second active pharmaceutical ingredient, and at least one top coating selected from the group consisting of enteric or delayed release coatings, protective coatings, and combinations thereof, on the at least one coating comprising the second active pharmaceutical ingredient. ### Claim 7 (depends on 1) The pharmaceutical composition of claim 1, wherein the capsule has an oblong shape. ### Claim 8 (depends on 1) The pharmaceutical composition of claim 1, wherein the at least one coating comprising the second active pharmaceutical ingredient comprises at least one compound present in an amount sufficient to prevent oxidative degradation of the second active pharmaceutical ingredient for a pharmaceutically acceptable duration of time. ### Claim 9 (depends on 1) The pharmaceutical composition of claim 1, wherein the at least one coating comprising the second active pharmaceutical ingredient has a thickness sufficient to prevent oxidative degradation of the second active pharmaceutical ingredient for a pharmaceutically acceptable duration of time. ### Claim 10 (depends on 1) A method of treating a condition or disease independently selected from the group consisting of hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease (CHD), vascular disease, and atherosclerotic disease, comprising administering to the subject the pharmaceutical composition of claim 1. ### Claim 11 (depends on 1) The pharmaceutical composition of claim 1 wherein the omega-3 fatty acid oil comprises EPA, DHA, a triglyceride of EPA, a triglyceride of DHA, EPA ethyl ester, DHA ethyl ester, or a mixture thereof. ### Claim 12 (depends on 11) The pharmaceutical composition of claim 11 wherein the omega-3 fatty acid oil comprises EPA ethyl ester and DHA ethyl ester. ### Claim 13 (depends on 11) The pharmaceutical composition of claim 11 wherein the omega-3 fatty acid oil comprises at least 80% EPA and DHA, about 40% to about 55% EPA, and about 30% to about 60% DHA, in an EPA:DHA weight ratio of from 1:2 to 2:1, and wherein the percentage by weight is based on the total fatty acid content in the capsule and on the ethyl ester form of the fatty acids. ### Claim 14 (depends on 13) The pharmaceutical composition of claim 13 wherein the EPA and DHA are in the ethyl ester form. ### Claim 15 (depends on 1) The pharmaceutical composition of claim 1 wherein the statin compound is selected from pitavastatin, pravastatin, simvastatin, lovastatin, atorvastatin, and fluvastatin. ### Claim 16 (depends on 11) The pharmaceutical composition of claim 11 wherein the statin compound is selected from pitavastatin, pravastatin, simvastatin, lovastatin, atorvastatin, and fluvastatin. ### Claim 17 (depends on 14) The pharmaceutical composition of claim 14 wherein the statin compound is selected from pitavastatin, pravastatin, simvastatin, lovastatin, atorvastatin, and fluvastatin. ### Claim 18 (depends on 14) The pharmaceutical composition of claim 14 wherein the statin compound is simvastatin. ### Claim 19 (depends on 1) The pharmaceutical composition of claim 1, wherein the capsule further comprises a solubilizer. ### Claim 20 (depends on 14) The pharmaceutical composition of claim 14, wherein the capsule further comprises a solubilizer. ### Claim 21 (depends on 18) The pharmaceutical composition of claim 18, wherein the capsule further comprises a solubilizer.