METHOD AND COMPOSITION FOR ADMINISTERING AN NMDA RECEPTOR ANTAGONIST TO A SUBJECT
The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
1 - 58 . (canceled)
59 . A pharmaceutical composition in a capsule dosage form comprising 25 mg memantine or a pharmaceutically acceptable salt thereof, wherein the composition is formulated as beads with an extended release coating, wherein oral administration of the capsule provides a memantine Tmax that is about 8-16 hours shifted relative to immediate release memantine, and wherein at least 95% of the memantine in the capsule is in the extended release form.
60 . A solid pharmaceutical composition comprising an extended release form of memantine or a pharmaceutically acceptable salt thereof, wherein the composition:
(i) is in a pellet containing a capsule dosage form for oral administration;
(ii) exhibits a dissolution of <50% in 4 hours, <70% in 6 hours, <80% in 8 hours and >90% in 12 hours in acidic or neutral conditions; and
(iii) exhibits a Tmax of 8-16 hours shifted relative to an immediate release form.
61 . A pharmaceutical composition in a unit dosage form comprising memantine or a pharmaceutically acceptable salt thereof, wherein the composition is in a sustained release form, and wherein the composition comprises coated cores having about 8%-16.5% (by weight) a sustained release coating comprising:
(i) ethyl cellulose;
(ii) a porosity enhancer selected from the group consisting of PVP and HPMC;
(iii) a plasticizer, and
(iv) an ethyl cellulose to porosity enhancer ratio of about 8:2 to 9:1.
62 . A pharmaceutical composition comprising 25-40 mg of memantine or a salt thereof in a sustained release form and least one pharmaceutically acceptable carrier wherein the composition is in a unit dosage form, wherein the composition exhibits a shift in Tmax by at least 8 hours relative to an immediate release form of memantine, and wherein the composition is in a coated pellet or capsule form.
63 . A pharmaceutical composition comprising 25-40 mg of memantine or a salt thereof in a sustained release form and least one pharmaceutically acceptable carrier wherein the composition is in a unit dosage form, wherein the composition exhibits a DC/DT of less than 50% of an immediate release form of memantine, and wherein the composition is in a coated pellet or capsule form.
64 . A pharmaceutical composition comprising 25-40 mg of memantine or a salt thereof in a sustained release form and least one pharmaceutically acceptable carrier wherein the composition is in a unit dosage form, wherein the composition exhibits a Cmax/Cmean of about 2 to 2.5 from 1 hour to 6 hours and wherein the composition is in a coated pellet or capsule form.
65 . A pharmaceutical composition in a unit dosage form for oral administration, the composition comprising:
(i) 5-40 mg memantine or a pharmaceutically acceptable salt thereof; and
(ii) donepezil or a pharmaceutically acceptable salt thereof;
wherein at least one of the memantine or pharmaceutically acceptable salt thereof or said donepezil or pharmaceutically acceptable salt thereof is provided in an extended release dosage form.