Gastric Retained Gabapentin Dosage Form
First Claim
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1. A dosage form, comprising:
- a matrix comprising gabapentin, wherein upon ingestion of the dosage form by a human gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUCinf.
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Abstract
A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.
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27 Claims
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1. A dosage form, comprising:
a matrix comprising gabapentin, wherein upon ingestion of the dosage form by a human gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUCinf. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A dosage form, comprising:
a matrix comprising 300 mg or 600 mg gabapentin, wherein upon ingestion by a human of one 600 mg dosage form or upon ingestion of two 300 mg dosage forms gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUCinf. - View Dependent Claims (10, 11, 12, 13, 14)
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15. A method of treating a condition responsive to a therapeutic dose of gabapentin, comprising:
orally administering to a human a dosage form comprising a matrix comprising gabapentin, wherein upon ingestion of the dosage form gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUCinf. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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22. A method of treating a condition responsive to a therapeutic dose of gabapentin, comprising:
orally administering to a human a dosage form comprising a matrix comprising gabapentin, wherein gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a longer time to the maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUCinf. - View Dependent Claims (23, 24, 25, 26, 27)
Specification