Gastric retained gabapentin dosage form

  • US 8,192,756 B2
  • Filed: 05/19/2011
  • Issued: 06/05/2012
  • Est. Priority Date: 10/25/2001
  • Status: Active Grant
First Claim
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1. A dosage form, comprising:

  • comprising from 100 mg to 4800 mg of therapeutically effective amount of gabapentin or pharmaceutically acceptable salt thereof, dispersed in a single matrixwherein the matrix comprises at least one swellable hydrophilic polymer that swells unrestrained dimensionally by imbibing water to increase its size to promote gastric retention of the dosage form in the stomach in a fed mode,wherein upon once-daily or twice-daily ingestion of the dosage form gabapentin is released from the matrix over a period of at least five hours wherein at least 40 wt% of the gabapentin is retained in the matrix one hour after administration, andwherein the gabapentin is released at a rate sufficient to achieve a lower maximum plasma concentration (Cmax) compared to an equal dose of gabapentin provided by an immediate release dosage form, and without loss in bioavailability as measured by the area under the curve (AUCinfinity) as compared to the bioavailability which is achieved from an immediate release dosage form comprising the same dose of gabapentin.

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