Compositions for the treatment of CNS-related conditions
DCFirst Claim
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1. A method of treating a patient with a neurological condition, comprising orally administering to a human subject in need thereof:
- (a) 22.5 to 37.5 mg memantine or a pharmaceutically acceptable salt thereof provided in an extended release dosage form, wherein administration of a dose of said 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; and
(b) a therapeutically effective amount of immediate release donepezil;
wherein the neurological condition is selected from Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.
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Abstract
The invention provides compositions comprising extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil 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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10 Claims
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1. A method of treating a patient with a neurological condition, comprising orally administering to a human subject in need thereof:
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(a) 22.5 to 37.5 mg memantine or a pharmaceutically acceptable salt thereof provided in an extended release dosage form, wherein administration of a dose of said 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; and (b) a therapeutically effective amount of immediate release donepezil;
wherein the neurological condition is selected from Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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Specification