Composition for administering an NMDA receptor antagonist to a subject
DC CAFCFirst Claim
1. A solid pharmaceutical composition in a unit dosage form for oral administration comprising an extended release formulation of 22.5 mg to 30 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 concentration of memantine as a function of time (dC/dT) that is:
- (a) 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-Tmax of the immediate release form of memantine; and
(b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours;
wherein dC/dT is measured in a single-dose human PK study.
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Abstract
The invention provides compostions for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
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Citations
16 Claims
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1. A solid pharmaceutical composition in a unit dosage form for oral administration comprising an extended release formulation of 22.5 mg to 30 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 concentration of memantine as a function of time (dC/dT) that is:
- (a) 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-Tmax of the immediate release form of memantine; and
(b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours;
wherein dC/dT is measured in a single-dose human PK study. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
- (a) 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-Tmax of the immediate release form of memantine; and
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9. A solid pharmaceutical composition in a unit dosage form for oral administration comprising an extended release formulation of 22.5 mg to 30 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 concentration of memantine as a function of time (dC/dT) that is:
- (a) 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 and 6 hours of administration of memantine; and
(b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours;
wherein dC/dT is measured in a single-dose human PK study. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
- (a) 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 and 6 hours of administration of memantine; and
Specification