Composition for administering an NMDA receptor antagonist to a subject
DC CAFC
First 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.
152 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
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- Resources
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Current AssigneeAdamas Pharma, LLC (Supernus Pharmaceuticals, Inc.)
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Original AssigneeAdamas Pharmaceuticals, Inc. (Supernus Pharmaceuticals, Inc.)
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InventorsWent, Gregory T., Fultz, Timothy J., Meyerson, Laurence R.
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Primary Examiner(s)Padmanabhan, Sreeni
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Assistant Examiner(s)Carter, Kendra D
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Application NumberUS13/536,008Publication NumberTime in Patent Office166 DaysField of Search514/597, 514/766, 424/400US Class Current514/597CPC Class CodesA61K 31/13 Amines A61K31/04 takes prec...A61K 9/4891 Coated capsules; Multilayer...A61P 25/00 Drugs for disorders of the ...A61P 25/02 for peripheral neuropathiesA61P 25/04 Centrally acting analgesics...A61P 25/08 Antiepileptics; Anticonvuls...A61P 25/16 Anti-Parkinson drugsA61P 25/24 AntidepressantsA61P 25/28 for treating neurodegenerat...A61P 25/30 for treating abuse or depen...
