IP Library › Patent Application 15887753
Patent Application
App. No. 15/887,753

COMPOSITION FOR ADMINISTERING AN NMDA RECEPTOR ANTAGONIST TO A SUBJECT

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Quick Facts
Patent No.
US None
App. No.
15/887,753
Abstract

The invention provides extended release amantadine compositions for once daily administration of amantadine to a subject.

Claims (12)

1 . A pharmaceutical composition in a unit dosage form comprising memantine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in a sustained release form, and wherein the pharmaceutical composition comprises coated cores having about 8% to 16.5% (by weight) of a sustained release coating comprising:

(i) ethyl cellulose; and

(ii) hydroxypropylmethyl cellulose (HPMC);

wherein the ethyl cellulose to HPMC ratio is about 8:2 to 9:1.

2 . The pharmaceutical composition of claim 1 , wherein the sustained release coating is substantially resistant to gastric conditions.

3 . The pharmaceutical composition of claim 1 , wherein the sustained release coating is erodible under conditions prevailing in the gastrointestinal tract.

4 . The pharmaceutical composition of claim 1 , comprising 12.5 mg to 40 mg memantine or a pharmaceutically acceptable salt thereof.

5 . The pharmaceutical composition of claim 1 , comprising 20 mg to 40 mg memantine or a pharmaceutically acceptable salt thereof.

6 . The pharmaceutical composition of claim 1 , comprising 22.5 mg to 40 mg memantine or a pharmaceutically acceptable salt thereof.

7 . The pharmaceutical composition of claim 1 , having a memantine in vitro dissolution profile of between 0.1% to 20% in one hour, 5% to 30% in two hours, 40% to 80% in six hours, and 50% to 90% in 10 hours, wherein the in vitro dissolution profile is determined using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37±0.5° C., in 500 ml water.

8 . The pharmaceutical composition of claim 1 , wherein the sustained release coating comprises about 11.2% to 16.5% (by weight) of the pharmaceutical composition.

9 . A pharmaceutical composition in a unit dosage form comprising memantine or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in an extended release form, and wherein the pharmaceutical composition comprises a coating comprising ethyl cellulose and hydroxypropyl methylcellulose.