# US 10,765,668 B2 · Oral tablet composition comprising dexlansoprazole, oral tablet comprising the same and method for manufacturing the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,668 B2 - Document ID: US10765668B2 - Status: Granted - Kind: B2 - Application number: 16/464,491 - Filed: 2017-05-10 - Published: 2019-09-12 - Granted: 2020-09-08 - Earliest claimed: 2016-11-28 - Assignees: Lotte Fine Chemical Co., Ltd. - Applicants: Lotte Fine Chemical Co., Ltd. - Inventors: Kwang Il Shin; Kyung Yeol Park; Sang Youb Lee - Web page: https://patentgrep.com/patent/US10765668B2 ## CPC - A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) - A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)} - A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} - A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates} - A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/28: Dragees; Coated pills or tablets {, e.g. with film or compression coating (A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209)} - A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 9/2886: {having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer (of the type active core-drug layer-inactive layer A61K9/209)} - A61K 9/2095: {Tabletting processes} - 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 The present invention relates to: an oral tablet composition comprising amorphous dexlansoprazole, mannitol having an average particle size of 100 to 400 μm, a disintegrating agent and a lubricant; an oral tablet comprising same; and a method for manufacturing same. The oral tablet composition, according to the present invention, exhibits excellent hardness, has a shortened disintegration time, and at the same time, may be used to provide an oral tablet having improved friability. In addition, according to the present invention, a dry direct compression method is used as the method for manufacturing the oral tablet, and thus an increase in production efficiency by simplifying the production process may be achieved. ## Claims ### Claim 1 An oral tablet composition comprising: 0:1 to 20 wt % amorphous dexlansoprazole, 20 to 50 wt % mannitol having an average particle size of 100 to 400 m, 25 to 55 wt % disintegrating agent selected from one or more of the group consisting of low-substituted hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, and crospovidone, and 0.5 to 5 wt % lubricant, wherein a friability of the oral tablet is 0.01 to 0.5%. ### Claim 2 (depends on 1) The oral tablet composition of claim 1, wherein the amorphous dexlansoprazole has an average particle size of 0.1 to 15 μm. ### Claim 3 (depends on 1) The oral tablet composition of claim 1, wherein the lubricant comprises one or more selected from the group consisting of magnesium stearate, stearic acid, zinc stearate, calcium stearate, sodium stearyl fumarate, talc, silicon dioxide, and colloidal silicon dioxide. ### Claim 4 (depends on 1) The oral tablet of claim 1, further comprising a core comprising the oral composition, an aqueous coating layer covering a surface of the core, and an enteric coating layer covering a surface of the aqueous coating layer. ### Claim 5 (depends on 4) The oral tablet of claim 4, wherein the aqueous coating layer comprises one or more selected from the group consisting of cellulose ether, polyvinylpyrrolidone, and polyvinyl alcohol. ### Claim 6 (depends on 5) The oral tablet of claim 5, wherein the cellulose ether comprises one or more selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxybutyl cellulose, hydroxypentyl cellulose, and hydroxypropyl butyl cellulose. ### Claim 7 (depends on 4) The oral tablet of claim 4, wherein the enteric coating layer comprises one or more selected from the group consisting of hydroxypropyl methyl cellulose phthalate (HPMCP), hydroxypropyl methyl cellulose acetate succinate (HPMCAS), cellulose acetate phthalate, and derivatives thereof. ### Claim 8 (depends on 1) A method for manufacturing the oral tablet according to claim 1, the method comprising: steps of (1) mixing amorphous dexlansoprazole, mannitol having an average particle size of 100 to 400 pm, and a disintegrating agent; (2) inputting and mixing a lubricant into the mixture obtained according to Step (1); and (3) compressing the mixture obtained according to Step (2). ### Claim 9 (depends on 8) The method of claim 8, wherein the compression in Step (3) is a dry direct compression method. ### Claim 10 (depends on 8) The method of claim 8, further comprising: steps of coating the mixture compressed according to Step (3) with an aqueous coating layer; and coating a surface of the aqueous coating layer with an enteric coating layer.