IP Library › Patent Application 16295914
Patent Application
App. No. 16/295,914

COMPOSITION FOR ADMINISTERING AN NMDA RECEPTOR ANTAGONIST TO A SUBJECT

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Quick Facts
Patent No.
US None
App. No.
16/295,914
Abstract

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

Claims (19)

1 - 9 . (canceled)

10 . A method of treating a human subject with Parkinson's disease, comprising orally administering to a human subject with Parkinson's disease once-daily a composition comprising:

(i) a drug, wherein the drug is an NMDA receptor antagonist or a pharmaceutically acceptable salt thereof; and

(ii) at least one excipient;

wherein:

at least 50% of the drug is in an extended release form;

the composition has an in vitro dissolution profile of between 40% and 60% in 2 hours, between 60% and 80% in 6 hours, and greater than 80% in 8 hours; and

the daily dose of drug administered to the human subject is between 20 mg to 500 mg.

11 . The method of claim 10 , wherein the daily dose of the drug administered to the human subject is between 200 mg to 500 mg.

12 . The method of claim 10 , wherein at least a portion of the drug is in an immediate release form.

13 . The method of claim 10 , wherein at least 75% of the drug is in an extended release form.

14 . The method of claim 10 , wherein at least 90% of the drug is in an extended release form.

15 . The method of claim 10 , wherein the NMDA receptor agonist is amantadine.

16 . The method of claim 15 , wherein the human subject has dyskinesia.

17 . The method of claim 16 , wherein the frequency or severity of dyskinesia is reduced after administration.

18 . The method of claim 16 , wherein the dyskinesia is levodopa-induced dyskinesia.

19 . The method of claim 10 , wherein the Tmax of the drug in the composition is shifted by 2 to 16 hours, relative to an immediate release dosage form.

20 . The method of claim 10 , wherein the composition is administered at a therapeutically effective dose from the onset of therapy.

21 . The method of claim 10 , wherein the extended release form comprises an osmotic device.