# US 10,478,429 B2 · Abuse deterrent dosage forms > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,429 B2 - Document ID: US10478429B2 - Status: Granted - Kind: B2 - Application number: 15/795,515 - Filed: 2017-10-27 - Published: 2018-03-01 - Granted: 2019-11-19 - Earliest claimed: 2015-10-07 - Assignees: Patheon Softgels, Inc. - Applicants: Patheon Softgels Inc - Inventors: Justin Hughey; Saujanya Gosangari; Chue Hue Yang - Web page: https://patentgrep.com/patent/US10478429B2 ## CPC - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)} - A61K 9/4858: {Organic compounds} - A61K 9/4866: {Organic macromolecular compounds} - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - 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 Described herein are oral abuse deterrent pharmaceutical compositions, methods for making the same, and methods for treating pain by administering the pharmaceutical composition to a subject in need thereof. In particular, an oral abuse deterrent pharmaceutical composition comprising a soft capsule and a controlled release matrix comprising oxycodone are described. ## Claims ### Claim 1 A controlled release oral pharmaceutical composition comprising: (a) about 35% to about 70% by mass glyceryl monolinoleate; (b) about 20% to about 50% by mass polyethylene oxide having an average molecular weight (Mv) of about 1,00,000 to about 7,000,000; and (c) one or more active pharmaceutical ingredients. ### Claim 2 (depends on 1) The composition of claim 1, wherein the composition further comprises one or more pharmaceutically acceptable excipients. ### Claim 3 (depends on 1) The composition of claim 1, wherein the composition further comprises one or more pharmaceutically acceptable antioxidants. ### Claim 4 (depends on 3) The composition of claim 3, wherein the antioxidant comprises about 0.05% to about 0.5% of the composition by mass. ### Claim 5 (depends on 3) The composition of claim 3, wherein the antioxidant comprises butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), or a combination thereof. ### Claim 6 (depends on 1) The composition of claim 1, wherein the polyethylene oxide comprises a polyethylene oxide having an average molecular weight (Mv) of about 4,000,000. ### Claim 7 (depends on 1) The composition of claim 1, wherein the composition comprises a mass ratio of polyethylene oxide to glyceryl monolinoleate of about 1:2. ### Claim 8 (depends on 1) The composition of claim 1, wherein the composition comprises: (a) about 35% to about 70% by mass of glyceryl monolinoleate; (b) about 20% to about 50% by mass of polyethylene oxide; and (c) about 1% to about 30% by mass of one or more active pharmaceutical ingredients. ### Claim 9 (depends on 8) The composition of claim 8, further comprising: (d) about 0.1% to about 0.4% by mass of BHA; and (e) about 0.05% to about 0.1% by mass of BHT. ### Claim 10 (depends on 1) The composition of claim 1, wherein the composition comprises: (a) about 50% to about 70% by mass of glyceryl monolinoleate; (b) about 25% to about 40% by mass of polyethylene oxide; (c) about 0.1% to about 0.4% by mass of BHA; (d) about 0.05% to about 0.1% by mass of BHT; and (e) about 1% to about 20% of by mass of one or more active pharmaceutical ingredients. ### Claim 11 An oral controlled release dosage form comprising a capsule encapsulating: (a) about 50% to about 70% by mass glyceryl monolinoleate; (b) about 25% to about 40% by mass polyethylene oxide comprising an average molecular weight (Mv) of about 1,00,000 to about 7,000,000; and (c) about 1% to about 20% by mass of one or more active pharmaceutical ingredients; and the dosage form having been heated to about 50° C. to about 80° C. for about 10 min to about 180 min, and cooled to room temperature by reducing the temperature at a rate of about 2° C. to about 10° C. per about 5 min to about 15 min. ### Claim 12 (depends on 11) The dosage form of claim 11, wherein the amount of the one or more active pharmaceutical ingredients is about 5 mg to about 100 mg. ### Claim 13 (depends on 11) The dosage form of claim 11, wherein the capsule is coated with a polyvinyl alcohol coating. ### Claim 14 (depends on 11) The dosage form of claim 11, wherein the dosage form exhibits an in vitro dissolution rate at pH 1.2 of about 50% after about 90 minutes. ### Claim 15 (depends on 11) A kit for dispensing a controlled release dosage form comprising: (a) one or more dosage forms of claim 11; (b) one or more receptacles comprising a tamper evident, moisture proof packaging comprising blister or strip packs, aluminum blisters, transparent or opaque polymer blisters or pouches, polypropylene tubes, colored blister materials, tubes, bottles, or bottles optionally containing child-resistant features, optionally comprising a desiccant; and (c) optionally, an insert comprising instructions or prescribing information for the dosage form. ### Claim 16 A method for manufacturing an abuse deterrent dosage form comprising: (a) combining about 35% to about 70% by mass glyceryl monolinoleate, about 20% to about 50% by mass polyethylene oxide having a molecular weight (Mv) of about 1,00,000 to about 7,000,000, and one or more active pharmaceutical ingredients; (b) encapsulating the combination into capsules; (c) incubating the capsules at about 50° C. to about 80° C. for about 10 min to about 180 min; and (d) cooling the capsules to room temperature. ### Claim 17 (depends on 16) The method of claim 16, wherein the capsules produced in step (b) are coated with a coating prior to the incubating of step (c). ### Claim 18 (depends on 16) The method of claim 16, wherein the capsules are cooled in step (d) by reducing the temperature at a rate of about 2° C. to about 10° C. per about 5 to about 15 min.