Method and composition for adminstering an NMDA receptor antagonist to a subject
First Claim
1. 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.
6 Assignments
0 Petitions
Accused Products
Abstract
The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
-
Citations
58 Claims
- 1. 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±
-
11. 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. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
- 0.5°
-
21. 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. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28)
- 10.9*
- 29. 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.
- 48. 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.
-
57. 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.
Specification