# US 8,148,393 B2 · Zolpidem tablets > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,148,393 B2 - Document ID: US8148393B2 - Status: Granted - Kind: B2 - Application number: 11/561,737 - Filed: 2006-11-20 - Published: 2007-07-19 - Granted: 2012-04-03 - Earliest claimed: 2005-11-18 - Assignees: Synthon BV - Inventors: Frans van Dalen; Korinde Annemarie Jansen; Farid Abedin Dorkoosh - Web page: https://patentgrep.com/patent/US8148393B2 ## CPC - A61K 31/435: having six-membered rings with one nitrogen as the only ring hetero atom - 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 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin} - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof - A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48) - 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 A zolpidem tablet having modified release is designed as a tablet-in-tablet dosage form. ## Claims ### Claim 1 A zolpidem oral tablet, comprising: (a) an inner tablet core comprising zolpidem or a pharmaceutically acceptable salt thereof and a controlled release matrix, wherein said tablet core comprises 5 to 20% of said zolpidem or pharmaceutically acceptable salt, 15 to 40% of an HPMC, 30 to 55% of an MCC, 0 to 20% of a polyol, 2 to 20% of an acid, and 0 to 5% of one or more additional excipients; and (b) a compressed coating layer surrounding said inner tablet core, which comprises an effective amount of zolpidem or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, wherein said coating layer comprises 1 to 10% of said zolpidem or a pharmaceutically acceptable salt thereof, 20 to 40% of an MCC, 40 to 80% of a polyol, 0 to 10% of an HPMC, 1 to 10% of a disintegrant, and 0 to 5% of one or more additional excipients; wherein the mass of said coating layer is at least 2.5 times the mass of said tablet core. ### Claim 2 (depends on 1) The zolpidem tablet according to claim 1, wherein said tablet core has a mass within the range of 30 to 100 mg. ### Claim 3 (depends on 2) The zolpidem tablet according to claim 2, wherein said coating layer has a mass within the range of 150 to 300 mg. ### Claim 4 (depends on 1) The zolpidem tablet according to claim 1, wherein said tablet has a diameter within the range of 9 to 10.5 millimeters. ### Claim 5 (depends on 4) The zolpidem tablet according to claim 4, wherein said coating layer is about four times the mass of said tablet core. ### Claim 6 (depends on 1) The zolpidem tablet according to claim 1, wherein the total amount of zolpidem or its pharmaceutically acceptable salt contained in the tablet is within the range of 5 to 30 mg. ### Claim 7 (depends on 6) The zolpidem tablet according to claim 6, wherein said tablet core contains 2 to 20 mg of zolpidem or a pharmaceutically acceptable salt thereof and said coating layer contains 3 to 20 mg of zolpidem or a pharmaceutically acceptable salt thereof, each expressed in terms of zolpidem tartrate. ### Claim 8 (depends on 6) The zolpidem tablet according to claim 6, wherein the zolpidem is zolpidem tartrate. ### Claim 9 (depends on 8) The zolpidem tablet according to claim 8, wherein the total amount of zolpidem tartrate contained in the tablet is 6.25 mg or 12.5 mg. ### Claim 10 (depends on 6) The zolpidem tablet according to claim 6, wherein the amount of zolpidem in the tablet core is identical to the amount of zolpidem in the coating layer. ### Claim 11 (depends on 1) The zolpidem tablet according to claim 1, wherein said tablet is a direct compression tablet. ### Claim 12 (depends on 1) The zolpidem tablet according to claim 1, which further comprises a film coating surrounding said tablet. ### Claim 13 (depends on 1) The zolpidem tablet according to claim 1, wherein said tablet has a diameter of about 11 millimeters or less. ### Claim 14 (depends on 13) The zolpidem tablet according to claim 13, wherein said tablet core has a mass within the range of 50-70 mg and has a diameter of about 7 millimeters or less; and said coating layer has a mass within the range of 220 to 260 mg.