Gastric retained gabapentin dosage form
AssigneeDepomed, Inc.
InventorsBret Berner, Sui Yuen Eddie Hou, Gloria M. Gusler
Life of this patent
Estimating the term…
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.
Claims27
A method for the prophylactic treatment of migraine headaches comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment,
- wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and
- wherein upon ingestion of the dosage form the 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 (Cmax) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the 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.
A method of treating psychiatric disorders comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment, wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and
- wherein upon ingestion of the dosage form the 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 (Cmax) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured b the area under the plasma concentration-time curve, AUCinf.
A method of treating movement disorders comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment, wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and
- wherein upon ingestion of the dosage form the 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 (Cmax) 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.
A method for administering a therapeutically effective amount of gabapentin to a mammal in need thereof, the method comprising
- administering gabapentin or a pharmaceutically acceptable salt thereof in a gastric retained dosage form comprising a matrix, wherein the gabapentin is dispersed in the matrix, and
- wherein the mammal is being treated for movement disorders, psychiatric disorders, or wherein the mammal is receiving prophylactic treatment for migraine headaches, and
- wherein upon ingestion of the dosage form the 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 (Cmax) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the 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.
Dependencies are inferred from the claim text.