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US 8,148,393 B2Granted
Zolpidem tablets
AssigneeSynthon BV
InventorsFrans van Dalen, Korinde Annemarie Jansen, Farid Abedin Dorkoosh
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Abstract
A zolpidem tablet having modified release is designed as a tablet-in-tablet dosage form.
Claims14
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.
2 more elements
Dependencies are inferred from the claim text.