Method and composition for adminstering an NMDA receptor antagonist to a subject
AssigneeAdamas Pharmaceuticals, Inc.
InventorsGregory Went, Timothy Fultz, Seth Porter, Laurence Meyerson, Timothy Burkoth
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Abstract
The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
Claims58
A composition comprising a modified release coating or matrix and an N-methyl-D-aspartate (NMDA) receptor antagonist, wherein said NMDA receptor antagonist has an in vitro dissolution profile in water that is substantially identical to its in vitro dissolution profile in a dissolution medium having a pH of 1.2 and wherein said dissolution profile ranges between 0.1-20% in one hour, 5-30% in two hours, 40-80% in six hours, greater than or equal to 70% in 10 hours, and greater than or equal to 90% in 12 hours as measured using a USP type II (paddle) dissolution system at 50 rpm, at a temperature of 37±0.5° C.
A composition comprising a modified release coating or matrix and memantine, wherein memantine has an in vitro dissolution profile ranging between 0-60% one hour, 0-86% in two hours, 0.6-100% in six hours, 3-100% in 10 hours, and 8-100% in 12 hours as measured using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37±0.5° C., in water.
A composition comprising memantine and a sustained release coating or matrix, wherein the fraction of released memantine is greater or equal to 0.01(0.297+0.0153*e(0.515*t)) and less than 1-e(−10.9*t) as measured using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37±0.5° C., in water, wherein t is the time in hours and wherein t is greater than zero and equal or less than 17.
A method of treating, preventing or reducing a neurologic or neuropsychiatric condition comprising administering to a subject at risk of having or having said condition a composition comprising an NMDA receptor antagonist provided in a modified release dosage form, wherein said subject is administered said NMDA receptor antagonist at a substantially identical dose from the start of therapy.
A method of preparing a pharmaceutical composition for the treatment of a condition associated with a deregulation in NMDA receptor activity by providing a matrix or coated core to provide sustained release of a NMDA receptor antagonist, wherein said NMDA receptor antagonist is present in sufficient quantity to treat said condition, using a therapy that involves administering to a subject substantially identical doses of said NMDA receptor antagonist from the onset of said therapy.
A method of treating, preventing or reducing a neurologic or neuropsychiatric condition comprising administering to a subject at risk of having or having said condition a composition comprising an NMDA receptor antagonist provided in a modified release dosage form, wherein said subject is administered said NMDA receptor antagonist at a substantially identical dose from the start of therapy, no more than once every 24 hours.
Dependencies are inferred from the claim text.