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Claims for Patent: 8,598,233

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Claims for Patent: 8,598,233

Title:Method for administering an NMDA receptor antagonist to a subject
Abstract: Compositions and methods for administering memantine to a subject are provided. In particular, a solid pharmaceutical composition in a unit dosage form for once daily oral administration is provided. The compositions comprises an extended release formulation of 22.5 mg to 33.75 mg memantine, or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is less than 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study. Methods of treating dementia, in particular Alzheimer's diseases, using the compositions are provided.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee: Adamas Pharmacueticals, Inc. (Emeryville, CA)
Application Number:13/751,876
Patent Claims: 1. A solid pharmaceutical composition in a unit dosage form for once daily oral administration comprising an extended release formulation of 22.5 mg to 33.75 mg memantine, or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is less than 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

2. The composition of claim 1, comprising 22.5 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof.

3. The composition of claim 1, comprising 28 mg memantine or a pharmaceutically acceptable salt thereof.

4. The composition of claim 1, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

5. The composition of claim 4, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.

6. The composition of claim 2, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

7. The composition of claim 6, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.

8. The composition of claim 3, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

9. The composition of claim 8, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.

10. A solid pharmaceutical composition in an unit dosage form consisting essentially of 22.5 to 37.5 mg memantine or a pharmaceutically acceptable salt thereof provided in an extended release dosage form, wherein administration of the dosage form provides a mean plasma memantine concentration profile characterized by a change in memantine concentration of memantine as a function of time (dC/dT) that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours of administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

11. The composition of claim 10, comprising 22.5 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof.

12. The composition of claim 10, comprising 28 mg memantine or a pharmaceutically acceptable salt thereof.

13. The composition of claim 10, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

14. The composition of claim 13, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.

15. The composition of claim 11, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

16. The composition of claim 15, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.

17. The composition of claim 12, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by dC/dT that is 2.1 ng/ml/hr or less, determined in a time period of 0 hours to 4 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study.

18. The composition of claim 17, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 hours to 4 hours after administration of memantine.
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