Gastric retentive gabapentin dosage forms and methods for using same
AssigneeDepomed, Inc.
InventorsBret Berner, Sui Yuen Eddie Hou, Theophilus Gana, Marilou Cramer
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AssigneeDepomed, Inc.
InventorsBret Berner, Sui Yuen Eddie Hou, Theophilus Gana, Marilou Cramer
Estimating the term…
Provided is a method of treating a patient suffering from a pain state by administering to the patient a gastric retentive dosage form of gabapentin that is capable of administration in once-daily or twice daily dosing regimens. By reducing the need to administer gabapentin from the thrice-daily administrations characteristic of immediate release gabapentin, the gastric retentive gabapentin dosage forms provided herein have the advantages of improving patient compliance for gabapentin treatment. In addition to the foregoing, the gastric retentive gabapentin dosages forms also exhibit decreased blood plasma concentrations and increased bioavailability throughout the dosing regimen.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to treat a patient suffering from a pain state, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to treat a patient suffering from a pain state, wherein said medicament is to be administered to a patient in a twice-daily dosing regimen within a single 24 hour period.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to reduce or eliminate side effects associated with γ-aminobutyric acid (GABA) analogs, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to reduce or eliminate side effects associated with γ-aminobutyric acid (GABA) analogs, wherein said medicament is to be administered to a patient in a twice-daily dosing regimen within a single 24 hour period.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to reduce or eliminate side effects associated with γ-aminobutyric acid (GABA) analogs, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period or in a twice daily dosing regimen in which the dose in the morning and dose in the evening are not equal, also within a single 24 hour period, and wherein said medicament upon administration to a patient as a single dose results in blood plasma levels of the patient that exhibit a maximum concentration (Cmax) of gabapentin that is approximately 15% to approximately 85% less than Cmax for a comparable dose of immediate release gabapentin also administered as a single dose, and wherein upon administration, bioavailability (AUC from 0 to 24 hours at steady-state) of the gabapentin at 2400 mg is approximately 80% to approximately 150% of the AUC for a comparable total daily dose of immediate release gabapentin.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to reduce or eliminate side effects associated with γ-aminobutyric acid (GABA) analogs, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period or in a twice daily dosing regimen in which the dose in the morning and dose in the evening are not equal, also within a single 24 hour period, and wherein said medicament upon administration to a patient as a single dose results in blood plasma levels of the patient that exhibit a maximum concentration (Cmax) of gabapentin that is approximately 15% to approximately 85% less than Cmax for a comparable dose of immediate release gabapentin also administered as a single dose, and wherein upon administration, bioavailability (AUC from 0 to 24 hours at steady-state) of the gabapentin at 1800 mg is approximately 80% to approximately 150% of the AUC for a comparable total daily dose of immediate release gabapentin.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to treat a patient suffering from a pain state, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period or in a twice daily dosing regimen in which the dose in the morning and dose in the evening are not equal, also within a single 24 hour period, and wherein said medicament upon administration to a patient as a single dose results in blood plasma levels of the patient that exhibit a maximum concentration (Cmax) of gabapentin that is approximately 15% to approximately 85% less than Cmax for a comparable dose of immediate release gabapentin also administered as a single dose, and wherein upon administration, bioavailability (AUC from 0 to 24 hours at steady-state) of the gabapentin at 2400 mg is approximately 70% to approximately 150% of the AUC for a comparable total daily dose of immediate release gabapentin.
Use of a medicament comprising a therapeutically effective amount of a GABA analog in a gastric retentive dosage form to treat a patient suffering from a pain state, wherein said medicament is to be administered to a patient in a once-daily dosing regimen within a single 24 hour period or in a twice daily dosing regimen in which the dose in the morning and dose in the evening are not equal, also within a single 24 hour period, and wherein said medicament upon administration to a patient as a single dose results in blood plasma levels of the patient that exhibit a maximum concentration (Cmax) of gabapentin that is approximately 15% to approximately 85% less than Cmax for a comparable dose of immediate release gabapentin also administered as a single dose, and wherein upon administration, bioavailability (AUC from 0 to 24 hours at steady-state) of the gabapentin at 1800 mg is approximately 70% to approximately 150% of the AUC for a comparable total daily dose of immediate release gabapentin.
Dependencies are inferred from the claim text.