Composition and method for treating neurological disease
DCFirst Claim
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1. A method comprising:
- orally administering to a human subject with Parkinson'"'"'s disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between 0 and 4 hours after administration.
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Abstract
Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.
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Citations
17 Claims
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1. A method comprising:
orally administering to a human subject with Parkinson'"'"'s disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between 0 and 4 hours after administration. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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2. A method comprising:
orally administering to a human subject with Parkinson'"'"'s disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between administration and Tmax of the immediate release form.
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3. A method comprising:
orally administering to a human subject with Parkinson'"'"'s disease a once-daily dose consisting of (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient, wherein the drug in the dose comprises an extended release form, and wherein the extended release form of the drug in the dose provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT provided by the same quantity of the drug in an immediate release form, wherein the dC/dT of the extended release form of the drug in the dose is measured in a single dose human pharmacokinetic study over the time period between 2 hours and 4 hours after administration and the dC/dT provided by the same quantity of the drug in an immediate release form is measured in a single dose human pharmacokinetic study over the time period between administration and Tmax of the immediate release form.
Specification