Once-daily administration of central nervous system drugs
First Claim
1. A once-daily delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours.
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Abstract
Delayed onset chronotherapeutic formulations of central nervous system (CNS) drugs are disclosed. The formulations comprise at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours, wherein the formulation exhibits at least one in vivo parameter, at steady state following administration to a subject, chosen from: an initial lag in absorption from about 2 hours to about 6 hours; a peak-to-trough ratio greater than or equal to about 4:1; a percent fluctuation of greater than or equal to about 100%; and a minimum time cover of greater than or equal to 50% of Cmax of at least 8 hours.
24 Citations
40 Claims
- 1. A once-daily delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours.
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3. A delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours, wherein the formulation exhibits at least one in vivo parameter, at steady state following administration to a subject, chosen from:
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a) an initial lag in absorption from about 2 hours to about 6 hours;
b) a peak-to-trough ratio greater than or equal to about 4;
1;
c) a percent fluctuation of greater than or equal to about 100%; and
d) a minimum time cover of greater than or equal to 50% of Cmax of at least 8 hours. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 39, 40)
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18. A delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours, wherein the formulation exhibits the following in vivo profile, at steady state following administration to a subject:
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a) an initial lag in absorption from about 2 hours to about 6 hours;
b) a peak-to-trough ratio greater than or equal to about 4;
1;
c) a percent fluctuation of greater than or equal to about 100%; and
d) a minimum time cover of greater than or equal to 50% of Cmax of at least 8 hours.
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19. A method of treating at least one CNS condition comprising administering, to a subject in need thereof, a delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours, wherein the formulation exhibits at least one in vivo parameter, at steady state following administration to a subject, chosen from:
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a) an initial lag in absorption from about 2 hours to about 6 hours;
b) a peak-to-trough ratio greater than or equal to about 4;
1;
c) a percent fluctuation of greater than or equal to about 100%; and
d) a minimum time cover of greater than or equal to 50% of Cmax of at least 8 hours. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A method of treating at least CNS condition comprising administering, to a subject in need thereof, a delayed onset formulation comprising at least one CNS drug or pharmaceutically acceptable salt thereof that exhibits an in vivo elimination half-life of less than about 8 hours, and wherein the formulation exhibits the following in vivo profile at steady state following administration to a subject:
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a) an initial lag in absorption from about 2 hours to about 6 hours;
b) a peak-to-trough ratio greater than or equal to about 4;
1;
c) a percent fluctuation of greater than or equal to about 100%; and
d) a minimum time cover of greater than or equal to 50% of Cmax of at least 8 hours.
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Specification